Engineer III, QA
Thermo Fisher Scientific · Santa Clara, CA · 3 wk ago
On-siteQuality Assurance$91k–$130k/yrFull-time
We need to output HTML fragment with sections: Use for section headings (About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). We must only include sections that have real specific content. We have:
- Work Schedule: Standard Office Hours (40/wk) -> schedule info.
- Environmental Conditions: Office -> maybe not needed; but schedule and environmental conditions maybe not needed as separate sections; we can include Schedule section with that info.
- About the role: The paragraph starting "As part of the Thermo Fisher Scientific team..." etc. That's about role.
- Responsibilities: The "How You Will Make an Impact:" and sub-bullets (Day In The Life etc). Those are responsibilities.
- Requirements: Education & Experience (Required and Preferred) maybe considered Requirements/Qualifications. Also Knowledge, Skills, Abilities (Required and Preferred) maybe Skills.
- Qualifications: Could be Education & Experience.
- Skills: Knowledge, Skills, Abilities.
- Benefits: Compensation And Benefits section includes salary range, bonus, total rewards details.
- Pay: Could be separate but we have salary range in Benefits; but we could still have Pay section with salary range. However instructions: Prefer a few substantive sections over many thin ones. We could combine Pay and Benefits into one Benefits section that includes salary and benefits. But they said use headings for Benefits, Pay, Schedule separately if content exists. We have schedule info, we have pay info (salary range). We have benefits info. Could make three sections: Schedule, Pay, Benefits. Or combine Pay and Benefits? The instruction: "Prefer a few substantive sections over many thin ones." So maybe combine Pay and Benefits into one Benefits section that includes salary and benefits. But they also said include a section ONLY when posting has real specific content for it. We have schedule, pay, benefits. Could make three sections; each is substantive enough. However "thin" maybe if only one line. Schedule: "Standard Office Hours (40/wk)" plus maybe environmental conditions? That's thin. Pay: salary range line plus bonus line. That's moderate. Benefits: list of items. That's substantive.
We could combine Schedule and Pay into a single "Work Details" but headings are prescribed; we must use those headings if we create them. Could we omit Schedule heading because it's thin? The instruction: "include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text". Schedule has specific content: "Standard Office Hours (40/wk)". That's specific. So we can include Schedule section with that line.
Similarly Pay: salary range is specific.
Thus we will have sections: About the role, Responsibilities, Requirements (or Qualifications?), Skills, Benefits, Pay, Schedule. But we need to avoid duplication. Let's map content:
About the role: The introductory paragraph about mission, location, etc. Could be "About the role". We'll put that.
Responsibilities: The "How You Will Make an Impact:" and the Day In The Life subsections (bulleted). We'll turn those into
for section headings (About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). We must only include sections that have real specific content. We have:
- Work Schedule: Standard Office Hours (40/wk) -> schedule info.
- Environmental Conditions: Office -> maybe not needed; but schedule and environmental conditions maybe not needed as separate sections; we can include Schedule section with that info.
- About the role: The paragraph starting "As part of the Thermo Fisher Scientific team..." etc. That's about role.
- Responsibilities: The "How You Will Make an Impact:" and sub-bullets (Day In The Life etc). Those are responsibilities.
- Requirements: Education & Experience (Required and Preferred) maybe considered Requirements/Qualifications. Also Knowledge, Skills, Abilities (Required and Preferred) maybe Skills.
- Qualifications: Could be Education & Experience.
- Skills: Knowledge, Skills, Abilities.
- Benefits: Compensation And Benefits section includes salary range, bonus, total rewards details.
- Pay: Could be separate but we have salary range in Benefits; but we could still have Pay section with salary range. However instructions: Prefer a few substantive sections over many thin ones. We could combine Pay and Benefits into one Benefits section that includes salary and benefits. But they said use headings for Benefits, Pay, Schedule separately if content exists. We have schedule info, we have pay info (salary range). We have benefits info. Could make three sections: Schedule, Pay, Benefits. Or combine Pay and Benefits? The instruction: "Prefer a few substantive sections over many thin ones." So maybe combine Pay and Benefits into one Benefits section that includes salary and benefits. But they also said include a section ONLY when posting has real specific content for it. We have schedule, pay, benefits. Could make three sections; each is substantive enough. However "thin" maybe if only one line. Schedule: "Standard Office Hours (40/wk)" plus maybe environmental conditions? That's thin. Pay: salary range line plus bonus line. That's moderate. Benefits: list of items. That's substantive.
We could combine Schedule and Pay into a single "Work Details" but headings are prescribed; we must use those headings if we create them. Could we omit Schedule heading because it's thin? The instruction: "include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text". Schedule has specific content: "Standard Office Hours (40/wk)". That's specific. So we can include Schedule section with that line.
Similarly Pay: salary range is specific.
Thus we will have sections: About the role, Responsibilities, Requirements (or Qualifications?), Skills, Benefits, Pay, Schedule. But we need to avoid duplication. Let's map content:
About the role: The introductory paragraph about mission, location, etc. Could be "About the role". We'll put that.
Responsibilities: The "How You Will Make an Impact:" and the Day In The Life subsections (bulleted). We'll turn those into - .
Requirements: Education & Experience (Required and Preferred) maybe also include "Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening." That's also a requirement. We'll include that.
Qualifications: Could be same as Requirements; but we should not duplicate. Perhaps we treat Education & Experience as Qualifications, and Knowledge, Skills, Abilities as Skills. Then we might not need a separate Requirements section. But we have to decide.
We have headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule.
We need to decide which to use. We could use Requirements for the mandatory eligibility (work authorization, background check) and maybe also for Education & Experience? But then Qualifications could be for Preferred qualifications? That seems messy.
Better: Use Requirements for Education & Experience (both required and preferred). Use Skills for Knowledge, Skills, Abilities (required and preferred). Use Qualifications maybe for certifications? But we already have preferred certifications in Knowledge, Skills, Abilities. Could omit Qualifications heading if no distinct content. The instruction: include a section ONLY when posting has real specific content for it. If we don't have distinct content for Qualifications, we should omit it.
Thus we will have sections: About the role, Responsibilities, Requirements (Education & Experience), Skills (Knowledge, Skills, Abilities), Benefits, Pay, Schedule.
We must not repeat job title as heading. No Job ID etc.
We must remove boilerplate: EEO, accommodations, apply now, link, etc. Also remove "At Thermo Fisher Scientific Inc., we are committed..." etc. Also remove "Join our exceptional team..." etc. Also remove "Apply now and seize..." etc. Also remove the link.
We must preserve all substantive information.
Let's extract content.
**About the role**: Paragraphs starting "As part of the Thermo Fisher Scientific team, you’ll discover meaningful work..." up to "Our technologies—including single-use bioreactors, mixers, fermenters, chromatography systems, centrifuges and process control software—help biopharmaceutical manufacturers improve efficiency, scale production and accelerate the delivery of life-changing therapies. By combining engineering innovation, manufacturing excellence and a commitment to quality, our teams help customers around the world bring breakthrough medicines to patients while advancing Thermo Fisher Scientific's mission of making the world healthier, cleaner and safer."
That's about the role and location. Also includes location: "Location: On-site Santa Clara, CA. Relocation assistance is NOT provided." That's also part of about role. We'll include that.
**Responsibilities**: The "How You Will Make an Impact:" and then the Day In The Life sections with bullet points. We'll capture all bullet points under responsibilities.
Let's list responsibilities bullet points:
From "Day In The Life: Quality Systems Management Lead and manage CAPA, deviation, nonconformance, and change control activities.Review quality records to ensure timely investigation, root cause determination, and effective corrective actions.Facilitate and document risk assessments using FMEA and other risk management methodologies.Ensure compliance with document control and quality system requirements.Monitor quality system metrics and support continuous improvement initiatives."
Then "Investigation & Compliance Support Lead investigations related to product, process, supplier, and customer quality issues.Perform root cause analysis using structured problem-solving methodologies.Support validation and qualification activities to ensure compliance with quality and regulatory requirements.Participate in internal audits, customer audits, and regulatory inspections.Support supplier quality activities including qualification, issue resolution, and corrective action effectiveness reviews.Assist in the development and implementation of corrective and preventive actions."
Then "Continuous Improvement & Risk Management Analyze quality data and trends to identify improvement opportunities.Lead or participate in continuous improvement projects to enhance product quality and process performance.Evaluate quality risks associated with products, processes, and changes.Support implementation of preventive quality strategies and best practices.Drive initiatives that improve compliance, efficiency, and customer satisfaction."
Then "Cross-Functional Collaboration & Customer Support Partner with Manufacturing, Engineering, Validation, Supply Chain, and Regulatory Affairs teams to resolve quality issues.Provide quality guidance and support for equipment, automation system, process, and product changes throughout the product lifecycle.Support customer inquiries, complaint investigations, and supplier quality activities.Communicate quality risks, trends, and recommendations to stakeholders.Promote a culture of quality, compliance, and continuous improvement across the organization.Perform other duties and responsibilities as assigned to support business objectives, quality initiatives, and operational requirements."
We'll turn each sentence into a list item? Could group but each bullet can be a sentence. We'll produce
- for each distinct duty.
**Requirements**: Education & Experience (Required and Preferred) plus work authorization and background check.
Required: "Advanced degree in Engineering, Life Sciences, Biotechnology or related field with 3 years of experience in quality assurance, quality engineering, or quality systems within a regulated industry such as biotechnology, pharmaceutical, medical device, life sciences, or related manufacturing environments OR Bachelor's degree in Engineering, Life Sciences, Chemistry, Biotechnology or related field with 5 years of experience in quality assurance, quality engineering, or quality systems within a regulated industry such as biotechnology, pharmaceutical, medical device, life sciences, or related manufacturing environments."
Then bullet list of experiences: "Experience managing CAPA, deviations, nonconformances, change controls, and quality investigations." "Experience conducting root cause analysis and implementing corrective and preventive actions." "Experience supporting GMP and/or ISO-compliant quality management systems." "Experience working cross-functionally with Manufacturing, Engineering, Validation, and Supply Chain teams."
Preferred: "ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent quality certification." "Formal training in GMP, ISO 9001, ISO 13485, risk management, or quality systems." "Experience within bioprocessing, automation systems, single-use technologies, life sciences equipment, or related regulated manufacturing environments." "Experience supporting customer audits, regulatory inspections, and supplier quality activities." "Experience with validation and qualification protocols." "Experience leading continuous improvement and risk management initiatives." "Experience utilizing electronic quality management systems (eQMS)."
Also "Must be legally authorized to work in the United States without sponsorship." "Must be able to pass a comprehensive background check, which includes a drug screening."
We'll include those as list items under Requirements.
**Skills**: Knowledge, Skills, Abilities (Required and Preferred).
Required: "Strong knowledge of GMP, GDP, ISO 9001, and applicable regulatory requirements; familiarity with ISO 13485 is preferred." "Expertise in quality systems including CAPA, deviation management, change control, document control, and risk management." "Strong understanding of root cause analysis methodologies and problem-solving tools." "Knowledge of validation, qualification, and quality risk management principles." "Ability to conduct risk assessments using FMEA and related methodologies." "Strong analytical skills with the ability to interpret quality data, identify trends, and recommend improvements." "Excellent written and verbal communication skills for interaction with internal stakeholders, customers, auditors, and regulatory agencies." "Strong project management and organizational skills with the ability to manage multiple priorities." "Ability to work independently while collaborating effectively within cross-functional teams." "Proficiency with Microsoft Office applications including Excel, Word, PowerPoint, and data analysis tools." "Experience using electronic Quality Management Systems (eQMS) such as TrackWise, MasterControl, or equivalent." "Strong attention to detail while maintaining a broad business perspective."
Preferred: "Knowledge of bioprocessing equipment, automation systems, and single-use technology products." "Experience with statistical analysis techniques and quality tools." "Familiarity with ERP systems such as SAP." "Experience with data visualization and reporting tools such as Power BI." "Additional language proficiency to support global customer and supplier interactions."
We'll put these as list items under Skills.
**Benefits**: Compensation And Benefits section.
We need to capture: "The salary range estimated for this position based in California is $91,000.00–$130,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: A choice of national medical and dental plans, and a national vision plan, including health incentive programsEmployee assistance and family support programs, including commuter benefits and tuition reimbursementAt least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policyRetirement and savings programs, such as our competitive 401(k) U.S. retirement savings planEmployees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards"
We need to format as list items.
We'll separate salary and bonus maybe
- for each distinct duty. **Requirements**: Education & Experience (Required and Preferred) plus work authorization and background check. Required: "Advanced degree in Engineering, Life Sciences, Biotechnology or related field with 3 years of experience in quality assurance, quality engineering, or quality systems within a regulated industry such as biotechnology, pharmaceutical, medical device, life sciences, or related manufacturing environments OR Bachelor's degree in Engineering, Life Sciences, Chemistry, Biotechnology or related field with 5 years of experience in quality assurance, quality engineering, or quality systems within a regulated industry such as biotechnology, pharmaceutical, medical device, life sciences, or related manufacturing environments." Then bullet list of experiences: "Experience managing CAPA, deviations, nonconformances, change controls, and quality investigations." "Experience conducting root cause analysis and implementing corrective and preventive actions." "Experience supporting GMP and/or ISO-compliant quality management systems." "Experience working cross-functionally with Manufacturing, Engineering, Validation, and Supply Chain teams." Preferred: "ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent quality certification." "Formal training in GMP, ISO 9001, ISO 13485, risk management, or quality systems." "Experience within bioprocessing, automation systems, single-use technologies, life sciences equipment, or related regulated manufacturing environments." "Experience supporting customer audits, regulatory inspections, and supplier quality activities." "Experience with validation and qualification protocols." "Experience leading continuous improvement and risk management initiatives." "Experience utilizing electronic quality management systems (eQMS)." Also "Must be legally authorized to work in the United States without sponsorship." "Must be able to pass a comprehensive background check, which includes a drug screening." We'll include those as list items under Requirements. **Skills**: Knowledge, Skills, Abilities (Required and Preferred). Required: "Strong knowledge of GMP, GDP, ISO 9001, and applicable regulatory requirements; familiarity with ISO 13485 is preferred." "Expertise in quality systems including CAPA, deviation management, change control, document control, and risk management." "Strong understanding of root cause analysis methodologies and problem-solving tools." "Knowledge of validation, qualification, and quality risk management principles." "Ability to conduct risk assessments using FMEA and related methodologies." "Strong analytical skills with the ability to interpret quality data, identify trends, and recommend improvements." "Excellent written and verbal communication skills for interaction with internal stakeholders, customers, auditors, and regulatory agencies." "Strong project management and organizational skills with the ability to manage multiple priorities." "Ability to work independently while collaborating effectively within cross-functional teams." "Proficiency with Microsoft Office applications including Excel, Word, PowerPoint, and data analysis tools." "Experience using electronic Quality Management Systems (eQMS) such as TrackWise, MasterControl, or equivalent." "Strong attention to detail while maintaining a broad business perspective." Preferred: "Knowledge of bioprocessing equipment, automation systems, and single-use technology products." "Experience with statistical analysis techniques and quality tools." "Familiarity with ERP systems such as SAP." "Experience with data visualization and reporting tools such as Power BI." "Additional language proficiency to support global customer and supplier interactions." We'll put these as list items under Skills. **Benefits**: Compensation And Benefits section. We need to capture: "The salary range estimated for this position based in California is $91,000.00–$130,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: A choice of national medical and dental plans, and a national vision plan, including health incentive programsEmployee assistance and family support programs, including commuter benefits and tuition reimbursementAt least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policyRetirement and savings programs, such as our competitive 401(k) U.S. retirement savings planEmployees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards" We need to format as list items. We'll separate salary and bonus maybe