Staff Engineer Quality Process
Stryker · Chandler, AZ · 1 mo ago
On-siteQuality Assurance$89k–$149k/yrFull-time
We need to output only HTML fragment with sections: headings for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to include only sections that have real specific content. The posting includes description of role (What You Will Do) and What You Need (requirements). Also includes Pay Ranges and Health benefits etc. Also location: Onsite in Chandler, Arizona. Also maybe "Some travel may be required." That's schedule? Not exactly schedule. No explicit schedule. Benefits are described. Pay range is given. So we can have sections: About the role (maybe summary), Responsibilities (What You Will Do), Requirements (What You Need), Benefits, Pay. Possibly also Qualifications? But we have Requirements covering qualifications. We could separate Qualifications and Skills but not needed. The instruction: Prefer a few substantive sections over many thin ones. So we can combine.
We must not repeat job title as heading. No Job ID. Remove boilerplate: cookie/navigation/legal/EEO etc. There's none.
We need to preserve all substantive info. So include location, onsite, Chandler AZ, some travel may be required (maybe under Responsibilities or a note). Could include under Responsibilities as a bullet.
We need to use
for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to include only sections that have real specific content. The posting includes description of role (What You Will Do) and What You Need (requirements). Also includes Pay Ranges and Health benefits etc. Also location: Onsite in Chandler, Arizona. Also maybe "Some travel may be required." That's schedule? Not exactly schedule. No explicit schedule. Benefits are described. Pay range is given. So we can have sections: About the role (maybe summary), Responsibilities (What You Will Do), Requirements (What You Need), Benefits, Pay. Possibly also Qualifications? But we have Requirements covering qualifications. We could separate Qualifications and Skills but not needed. The instruction: Prefer a few substantive sections over many thin ones. So we can combine.
We must not repeat job title as heading. No Job ID. Remove boilerplate: cookie/navigation/legal/EEO etc. There's none.
We need to preserve all substantive info. So include location, onsite, Chandler AZ, some travel may be required (maybe under Responsibilities or a note). Could include under Responsibilities as a bullet.
We need to use - for any list of duties/requirements/benefits. So we need to turn the responsibilities list into bullet list. Similarly requirements list into bullet list. Benefits list into bullet list.
We need to use
for prose.
We need headings
for sections.
Let's extract:
About the role: The first paragraph: "The Staff Quality Process Engineer will provide quality engineering leadership and direction in quality assurance, control, and preventative activities with a focus on continuous improvement of products and processes. Advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers. Mentor and provide technical direction across multiple areas of expertise. Ensure compliance with regulations and standards. This role is Onsite in Chandler, Arizona."
That's prose.
Responsibilities: The bullet list under "What You Will Do". Let's list each sentence as bullet.
- Work closely with operations and the business functions to ensure quality performance of product and processes.
- Work closely with customers, sales/marketing/field personnel, and cross-functional teams to address top quality issues.
- Mentors, provides oversight and approval of NC/CAPA, activist and high-level expert in problem-solving and root-causing activities.
- Initiates and leads in the development and improvement of the manufacturing processes for existing products.
- Oversight and leads investigations during concession management.
- Review and approval of change management activities, challenges effectiveness and drives strong review.
- Interpret KPI trends, drive continuous improvement process.
- Advocate of Human Factor practices, proficiency in the science of identification of mitigation.
- Subject matter expert in risk management practices and concepts.
- Develop and provide input by identifying opportunities and weaknesses.
- Proficiency in and provides technical direction in optimization of inspection methods and sampling.
- High proficiency in statistical methods and application.
- Engage in and may lead internal and external audits with regulatory representatives, providing effective narrative and description of topic of expertise and overview of the business. May manage audit logistics and/or preparation.
- Aids in the development of validation strategies for existing products.
- Support manufacturing transfers to other plants/facilities, leading quality activities.
- Responsible for initiation, internal containment, and support of ship and product holds for potential product escapes.
- Coach and mentor others in quality topics and activities.
- Some travel may be required.
Requirements: "What You Need" list.
- Bachelor of Science in engineering or related discipline.
- Minimum of 5+ years’ experience.
- Previous medical industry experience required.
- Understanding of US and International Medical Device Regulations.
- Previous product transfer experience required.
- Familiarity with ISO 13485, GDP, GMP required.
- Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).
- Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously.
- Preferred MS, CQE, or CRE.
- Six Sigma Green or Black belt.
- Experience in launching new production lines desired.
- Experience in interacting with regulatory agencies (FDA, MoH, TUV; etc.) desired.
- Ability to represent Quality function within and across project teams.
- Strong interpersonal skills, written, oral communication and negotiations skills.
- Strong in critical thinking and “outside the box” thinking.
- Highly developed problem-solving skills.
- Strong analytical skills.
- Demonstrated ability to successfully manage and complete projects in a matrix organization.
- Demonstrated ability to work independently and as part of cross-functional teams.
- Experience in working in a compliance risk situation.
Benefits: Health benefits list and Financial benefits list.
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.
Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.
Also mention Stryker offers innovative products... but that's maybe not benefit. Could be omitted as boilerplate? It's descriptive of company, maybe not needed. The instruction: preserve ALL substantive information; do not invent or summarize away detail. That paragraph about Stryker's impact may be considered substantive? It's about company, not directly job. Might be considered boilerplate? It's not cookie/navigation/legal/EEO etc. It's describing the company. Might be considered substantive but not required for job posting? The instruction says preserve ALL substantive information; do not invent or summarize away detail. So we should include that as prose maybe under a section like "About the Company" but we don't have a heading for that. Could add a paragraph after benefits as prose. However we should avoid creating thin sections. Could include as a
after benefits without a heading? But we need to use headings for sections only when we have specific content. We could add a section "About the Company" with that paragraph. But the instruction says use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It doesn't forbid other headings, but suggests those as examples. It says "use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." So we can use those headings; we could also add other headings if needed, but better to stick to those. The company description could be placed under About the role? Might be okay to add as a paragraph after About the role. But the About the role currently is a short paragraph; we could expand it to include company description. However that would mix role description with company info. Might be okay.
Pay: we have Pay Ranges: USN: $89,300 - $148,800 USD Annual. Also note "View the U.S. work location and transparency guide to find the pay range for your location." That's a link; we can ignore as boilerplate? It's instruction to view guide; maybe we can keep the pay range only. We'll include Pay section with that range.
Schedule: Not explicitly given; only "Some travel may be required." That's not schedule. So we omit Schedule section.
Thus sections: About the role (h3), Responsibilities (h3), Requirements (h3), Benefits (h3), Pay (h3). Possibly also Qualifications? But we have Requirements covering qualifications. We'll not duplicate.
Now format:
About the role
The Staff Quality Process Engineer will provide quality engineering leadership and direction in quality assurance, control, and preventative activities with a focus on continuous improvement of products and processes. Advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers. Mentor and provide technical direction across multiple areas of expertise. Ensure compliance with regulations and standards. This role is Onsite in Chandler, Arizona. Some travel may be required.
But we moved travel to responsibilities; maybe keep it there. We'll keep travel under responsibilities bullet.
Now Responsibilities:
Responsibilities
- Work closely with operations and the business functions to ensure quality performance of product and processes.
- Work closely with customers, sales/marketing/field personnel, and cross-functional teams to address top quality issues.
- Mentors, provides oversight and approval of NC/CAPA, activist and high-level expert in problem-solving and root-causing activities.
- Initiates and leads in the development and improvement of the manufacturing processes for existing products.
- Oversight and leads investigations during concession management.
- Review and approval of change management activities, challenges effectiveness and drives strong review.
- Interpret KPI trends, drive continuous improvement process.
- Advocate of Human Factor practices, proficiency in the science of identification of mitigation.
- Subject matter expert in risk management practices and concepts.
- Develop and provide input by identifying opportunities and weaknesses.
- Proficiency in and provides technical direction in optimization of inspection methods and sampling.
- High proficiency in statistical methods and application.
- Engage in and may lead internal and external audits with regulatory representatives, providing effective narrative and description of topic of expertise and overview of the business. May manage audit logistics and/or preparation.
- Aids in the development of validation strategies for existing products.
- Support manufacturing transfers to other plants/facilities, leading quality activities.
- Responsible for initiation, internal containment, and support of ship and product holds for potential product escapes.
- Coach and mentor others in quality topics and activities.
- Some travel may be required.
Requirements:
Requirements
- Bachelor of Science in engineering or related discipline.
- Minimum of 5+ years’ experience.
- Previous medical industry experience required.
- Understanding of US and International Medical Device Regulations.
- Previous product transfer experience required.
- Familiarity with ISO 13485, GDP, GMP required.
- Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).
- Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously.
- Preferred MS, CQE, or CRE.
- Six Sigma Green or Black belt.
- Experience in launching new production lines desired.
- Experience in interacting with regulatory agencies (FDA, MoH, TUV; etc.) desired.
- Ability to represent Quality function within and across project teams.
- Strong interpersonal skills, written, oral communication and negotiations skills.
- Strong in critical thinking and “outside the box” thinking.
- Highly developed problem-solving skills.
- Strong analytical skills.
- Demonstrated ability to successfully manage and complete projects in a matrix organization.
- Demonstrated ability to work independently and as part of cross-functional teams.
- Experience in working in a compliance risk situation.
Benefits:
Benefits
- Medical and prescription drug insurance
- Dental insurance
- Vision insurance
- Critical illness insurance
- Accident insurance
- Hospital indemnity insurance
- Personalized healthcare support
- Wellbeing program
- Tobacco cessation program
- Health Savings Account (HSA)
- Flexible Spending
for prose. We need headings
for sections. Let's extract: About the role: The first paragraph: "The Staff Quality Process Engineer will provide quality engineering leadership and direction in quality assurance, control, and preventative activities with a focus on continuous improvement of products and processes. Advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers. Mentor and provide technical direction across multiple areas of expertise. Ensure compliance with regulations and standards. This role is Onsite in Chandler, Arizona." That's prose. Responsibilities: The bullet list under "What You Will Do". Let's list each sentence as bullet. - Work closely with operations and the business functions to ensure quality performance of product and processes. - Work closely with customers, sales/marketing/field personnel, and cross-functional teams to address top quality issues. - Mentors, provides oversight and approval of NC/CAPA, activist and high-level expert in problem-solving and root-causing activities. - Initiates and leads in the development and improvement of the manufacturing processes for existing products. - Oversight and leads investigations during concession management. - Review and approval of change management activities, challenges effectiveness and drives strong review. - Interpret KPI trends, drive continuous improvement process. - Advocate of Human Factor practices, proficiency in the science of identification of mitigation. - Subject matter expert in risk management practices and concepts. - Develop and provide input by identifying opportunities and weaknesses. - Proficiency in and provides technical direction in optimization of inspection methods and sampling. - High proficiency in statistical methods and application. - Engage in and may lead internal and external audits with regulatory representatives, providing effective narrative and description of topic of expertise and overview of the business. May manage audit logistics and/or preparation. - Aids in the development of validation strategies for existing products. - Support manufacturing transfers to other plants/facilities, leading quality activities. - Responsible for initiation, internal containment, and support of ship and product holds for potential product escapes. - Coach and mentor others in quality topics and activities. - Some travel may be required. Requirements: "What You Need" list. - Bachelor of Science in engineering or related discipline. - Minimum of 5+ years’ experience. - Previous medical industry experience required. - Understanding of US and International Medical Device Regulations. - Previous product transfer experience required. - Familiarity with ISO 13485, GDP, GMP required. - Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics). - Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously. - Preferred MS, CQE, or CRE. - Six Sigma Green or Black belt. - Experience in launching new production lines desired. - Experience in interacting with regulatory agencies (FDA, MoH, TUV; etc.) desired. - Ability to represent Quality function within and across project teams. - Strong interpersonal skills, written, oral communication and negotiations skills. - Strong in critical thinking and “outside the box” thinking. - Highly developed problem-solving skills. - Strong analytical skills. - Demonstrated ability to successfully manage and complete projects in a matrix organization. - Demonstrated ability to work independently and as part of cross-functional teams. - Experience in working in a compliance risk situation. Benefits: Health benefits list and Financial benefits list. Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Also mention Stryker offers innovative products... but that's maybe not benefit. Could be omitted as boilerplate? It's descriptive of company, maybe not needed. The instruction: preserve ALL substantive information; do not invent or summarize away detail. That paragraph about Stryker's impact may be considered substantive? It's about company, not directly job. Might be considered boilerplate? It's not cookie/navigation/legal/EEO etc. It's describing the company. Might be considered substantive but not required for job posting? The instruction says preserve ALL substantive information; do not invent or summarize away detail. So we should include that as prose maybe under a section like "About the Company" but we don't have a heading for that. Could add a paragraph after benefits as prose. However we should avoid creating thin sections. Could include as a
after benefits without a heading? But we need to use headings for sections only when we have specific content. We could add a section "About the Company" with that paragraph. But the instruction says use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It doesn't forbid other headings, but suggests those as examples. It says "use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." So we can use those headings; we could also add other headings if needed, but better to stick to those. The company description could be placed under About the role? Might be okay to add as a paragraph after About the role. But the About the role currently is a short paragraph; we could expand it to include company description. However that would mix role description with company info. Might be okay.
Pay: we have Pay Ranges: USN: $89,300 - $148,800 USD Annual. Also note "View the U.S. work location and transparency guide to find the pay range for your location." That's a link; we can ignore as boilerplate? It's instruction to view guide; maybe we can keep the pay range only. We'll include Pay section with that range.
Schedule: Not explicitly given; only "Some travel may be required." That's not schedule. So we omit Schedule section.
Thus sections: About the role (h3), Responsibilities (h3), Requirements (h3), Benefits (h3), Pay (h3). Possibly also Qualifications? But we have Requirements covering qualifications. We'll not duplicate.
Now format:
About the role
The Staff Quality Process Engineer will provide quality engineering leadership and direction in quality assurance, control, and preventative activities with a focus on continuous improvement of products and processes. Advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers. Mentor and provide technical direction across multiple areas of expertise. Ensure compliance with regulations and standards. This role is Onsite in Chandler, Arizona. Some travel may be required.
But we moved travel to responsibilities; maybe keep it there. We'll keep travel under responsibilities bullet. Now Responsibilities:Responsibilities
- Work closely with operations and the business functions to ensure quality performance of product and processes.
- Work closely with customers, sales/marketing/field personnel, and cross-functional teams to address top quality issues.
- Mentors, provides oversight and approval of NC/CAPA, activist and high-level expert in problem-solving and root-causing activities.
- Initiates and leads in the development and improvement of the manufacturing processes for existing products.
- Oversight and leads investigations during concession management.
- Review and approval of change management activities, challenges effectiveness and drives strong review.
- Interpret KPI trends, drive continuous improvement process.
- Advocate of Human Factor practices, proficiency in the science of identification of mitigation.
- Subject matter expert in risk management practices and concepts.
- Develop and provide input by identifying opportunities and weaknesses.
- Proficiency in and provides technical direction in optimization of inspection methods and sampling.
- High proficiency in statistical methods and application.
- Engage in and may lead internal and external audits with regulatory representatives, providing effective narrative and description of topic of expertise and overview of the business. May manage audit logistics and/or preparation.
- Aids in the development of validation strategies for existing products.
- Support manufacturing transfers to other plants/facilities, leading quality activities.
- Responsible for initiation, internal containment, and support of ship and product holds for potential product escapes.
- Coach and mentor others in quality topics and activities.
- Some travel may be required.
Requirements
- Bachelor of Science in engineering or related discipline.
- Minimum of 5+ years’ experience.
- Previous medical industry experience required.
- Understanding of US and International Medical Device Regulations.
- Previous product transfer experience required.
- Familiarity with ISO 13485, GDP, GMP required.
- Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).
- Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously.
- Preferred MS, CQE, or CRE.
- Six Sigma Green or Black belt.
- Experience in launching new production lines desired.
- Experience in interacting with regulatory agencies (FDA, MoH, TUV; etc.) desired.
- Ability to represent Quality function within and across project teams.
- Strong interpersonal skills, written, oral communication and negotiations skills.
- Strong in critical thinking and “outside the box” thinking.
- Highly developed problem-solving skills.
- Strong analytical skills.
- Demonstrated ability to successfully manage and complete projects in a matrix organization.
- Demonstrated ability to work independently and as part of cross-functional teams.
- Experience in working in a compliance risk situation.
Benefits
- Medical and prescription drug insurance
- Dental insurance
- Vision insurance
- Critical illness insurance
- Accident insurance
- Hospital indemnity insurance
- Personalized healthcare support
- Wellbeing program
- Tobacco cessation program
- Health Savings Account (HSA)
- Flexible Spending