Quality Assurance Engineer - Medical Devices
Primary Talent Partners · Lafayette, CO · 1 mo ago
On-siteEngineering$45–$55/hrContract
We need to output HTML fragment with sections for headings where content exists. Use for section headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We must not repeat job title. Must not include Job ID etc. Must preserve all substantive info. Remove boilerplate: EEO, equal-opportunity, scam warning, application instructions, cookie/navigation/legal. Also remove duplicated lines. Must not create sections with filler like "commensurate with experience". Pay and Schedule: we have Pay: $45.00 - $55.00/hr; W2 contract, no PTO, no Benefits. ACA-compliant supplemental package available for enrollment. That's pay info. Schedule not given. So we should include Pay section only. Benefits: they say no Benefits, but ACA-compliant supplemental package available for enrollment. That's a benefit? It says no Benefits but supplemental package. The instruction: never create Benefits section unless posting actually states them. It states "no Benefits" and "ACA-compliant supplemental package available for enrollment." That's somewhat a benefit but they say no Benefits. Probably we should not create Benefits section because they explicitly say no Benefits. However we could include a brief note under Pay? But they said only include section when posting has real, specific content. The phrase "no Benefits" is specific content about benefits (i.e., lack thereof). Should we include Benefits section with that? The rule: never create Benefits section unless posting actually states them. It does state "no Benefits". So we could include Benefits section with that statement. However they also say "ACA-compliant supplemental package available for enrollment." That's a benefit. So we have some benefit info. So we should include Benefits section.
Schedule: not mentioned, so omit.
We need sections: About the role (maybe description intro), Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay. Possibly also "Qualifications" vs "Requirements" overlapping. The posting has "Must Have:" list which are requirements. Also there is a list of skills like "Design Quality Engineer", etc. That seems like skills. Also there is "Nice to Have skills:" list. So we can separate Requirements (Must Have) and Skills (Nice to Have). Also there is a paragraph describing responsibilities after "Description:" which includes bullet-like sentences. We'll put those under Responsibilities.
Also there is an introductory sentence: "Primary Talent Partners has a new contract opening for a Quality Assurance Engineer - Medical Devices with our medical device client in Lafayette, CO. This is a 6-month contract with a potential for extension." That's about the role. So About the role section.
We must not repeat job title. So we can just have About the role paragraph.
Now we need to format lists with
for section headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We must not repeat job title. Must not include Job ID etc. Must preserve all substantive info. Remove boilerplate: EEO, equal-opportunity, scam warning, application instructions, cookie/navigation/legal. Also remove duplicated lines. Must not create sections with filler like "commensurate with experience". Pay and Schedule: we have Pay: $45.00 - $55.00/hr; W2 contract, no PTO, no Benefits. ACA-compliant supplemental package available for enrollment. That's pay info. Schedule not given. So we should include Pay section only. Benefits: they say no Benefits, but ACA-compliant supplemental package available for enrollment. That's a benefit? It says no Benefits but supplemental package. The instruction: never create Benefits section unless posting actually states them. It states "no Benefits" and "ACA-compliant supplemental package available for enrollment." That's somewhat a benefit but they say no Benefits. Probably we should not create Benefits section because they explicitly say no Benefits. However we could include a brief note under Pay? But they said only include section when posting has real, specific content. The phrase "no Benefits" is specific content about benefits (i.e., lack thereof). Should we include Benefits section with that? The rule: never create Benefits section unless posting actually states them. It does state "no Benefits". So we could include Benefits section with that statement. However they also say "ACA-compliant supplemental package available for enrollment." That's a benefit. So we have some benefit info. So we should include Benefits section.
Schedule: not mentioned, so omit.
We need sections: About the role (maybe description intro), Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay. Possibly also "Qualifications" vs "Requirements" overlapping. The posting has "Must Have:" list which are requirements. Also there is a list of skills like "Design Quality Engineer", etc. That seems like skills. Also there is "Nice to Have skills:" list. So we can separate Requirements (Must Have) and Skills (Nice to Have). Also there is a paragraph describing responsibilities after "Description:" which includes bullet-like sentences. We'll put those under Responsibilities.
Also there is an introductory sentence: "Primary Talent Partners has a new contract opening for a Quality Assurance Engineer - Medical Devices with our medical device client in Lafayette, CO. This is a 6-month contract with a potential for extension." That's about the role. So About the role section.
We must not repeat job title. So we can just have About the role paragraph.
Now we need to format lists with - . For responsibilities, we have a paragraph that starts "Responsibilities may include the following and other duties may be assigned:" then a list of sentences separated by periods? Actually it's a long sentence with many clauses separated by periods. We can split each duty into separate
- . Let's extract:
- Develops, modifies, applies, and maintains standards for software systems quality operating methods, processes, and procedures.
- Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation.
- Defines appropriate measures to ensure product quality.
- Develops overall operating criteria to ensure implementation of the software quality program according to project, process and contract requirements and objectives.
- Ensures that projects and process control documentation are compliant with requirements, objectives and/or contracts.
- Reviews software systems design, change specifications, and plans against contractual and/or process requirements.
- Reviews include applicable specifications, materials, tools, techniques, and methodologies.
- Provides or directs verification and validation of software system requirements, traceability, and testability.
We need to preserve all substantive info; we can keep as list items.
Now Must Have list: It's a block of text with many items separated by line breaks? Let's parse:
"Must Have:
Computer and software validation
Change control of Medical Devices
Understanding of, and/or experience with, medical device regulations, including EU MDR, ISO 13485, and IEC 62304, as well as the changes needed to keep medical devices compliant with new and evolving regulations.
Understanding of non-medical product development processes and lifecycle requirements.
Serve as the voice of the Software Systems function on deliverables, providing guidance to cross-functional team members from a software and systems perspective.
Expertise in training development and delivery.
Broad understanding of how medical devices are developed, regulated, and approved in the European Union and the United States.
Familiarity with, or the ability to quickly learn, evolving medical device regulations, including emerging AI-related standards and requirements.
Expert-level process development skills, with the ability to create quality system documents for a wide range of users and product types, including software and AI-enabled applications
a Design Quality Engineer', 'Advanced understanding of design controls, quality system regulations, and failure investigation process and methodologies.Apply knowledge of design control principles and quality engineering techniques throughout the product development process.Can provide instruction and guidance of processes and proceduresdefect analysis skills', 'design and implementation of quality testing and validation toolsdevelopment and implementation of processes and proceduresSaMD"
This seems garbled due to copy-paste. We need to preserve substantive info but not invent. We'll try to extract meaningful items:
- Computer and software validation
- Change control of Medical Devices
- Understanding of, and/or experience with, medical device regulations, including EU MDR, ISO 13485, and IEC 62304, as well as the changes needed to keep medical devices compliant with new and evolving regulations.
- Understanding of non-medical product development processes and lifecycle requirements.
- Serve as the voice of the Software Systems function on deliverables, providing guidance to cross-functional team members from a software and systems perspective.
- Expertise in training development and delivery.
- Broad understanding of how medical devices are developed, regulated, and approved in the European Union and the United States.
- Familiarity with, or the ability to quickly learn, evolving medical device regulations, including emerging AI-related standards and requirements.
- Expert-level process development skills, with the ability to create quality system documents for a wide range of users and product types, including software and AI-enabled applications
- Advanced understanding of design controls, quality system regulations, and failure investigation process and methodologies.
- Apply knowledge of design control principles and quality engineering techniques throughout the product development process.
- Can provide instruction and guidance of processes and procedures
- Defect analysis skills
- Design and implementation of quality testing and validation tools
- Development and implementation of processes and procedures
Also there is "SaMD" maybe stands for Software as a Medical Device. Might be a skill.
We'll keep as list items, cleaning up obvious duplicates.
Now Nice to Have skills list:
"Nice to Have skills: 1-3 years of medical/clinical experience or exposure
2 years Medical Device experience
Agile QMS
Experience in Cloud Based Software
NC/CAPA"
We'll list those.
Now Benefits: "no PTO, no Benefits. ACA-compliant supplemental package available for enrollment." So we can say: No PTO, no traditional benefits; ACA-compliant supplemental package available for enrollment.
Pay: "$45.00 - $55.00/hr; W2 contract, no PTO, no Benefits." Actually pay line includes that. We'll separate.
We must not repeat info. Pay section: "$45.00 - $55.00/hr; W2 contract." Benefits section: "No PTO, no traditional benefits; ACA-compliant supplemental package available for enrollment."
Now we need to output HTML fragment only.
Structure:
About the role
Primary Talent Partners has a new contract opening for a Quality Assurance Engineer - Medical Devices with our medical device client in Lafayette, CO. This is a 6-month contract with a potential for extension.
Responsibilities
- ...
...
Requirements
- Computer and software validation
...
Skills
- Nice to Have: 1-3 years of medical/clinical experience or exposure
...
Maybe separate Requirements and Skills. But we have Must Have (requirements) and Nice to Have (skills). We'll label Skills as "Nice to Have Skills". Or we could have Skills section for Nice to Have.
We also might have Qualifications section but we already have Requirements. Could combine but better to follow instruction: use headings only when posting has real content. We have Requirements (Must Have) and Skills (Nice to Have). We'll output both.
Now Benefits:
Benefits
No PTO, no traditional benefits; ACA-compliant supplemental package available for enrollment.
Pay:
Pay
$45.00 - $55.00/hr; W2 contract.
We should not repeat "no PTO, no Benefits" in Pay because it's already in Benefits. But the original Pay line included that; we can keep Pay just the rate and contract type. However we might lose the "no PTO, no Benefits" info if we only put in Benefits. That's okay because we have Benefits section covering that. Ensure we don't duplicate.
Now check for any other info: location Lafayette, CO already in About the role. Contract duration 6-month with potential extension also there.
Now ensure we didn't include boilerplate: removed EEO, etc.
Now output HTML.
Let's craft list items precisely.
Responsibilities list:
- Develops, modifies, applies, and maintains standards for software systems quality operating methods, processes, and procedures.
- Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation.
- Defines appropriate measures to ensure product quality.
- Develops overall operating criteria to ensure implementation of the software quality program according to project, process and contract requirements and objectives.
- Ensures that projects and process control documentation are compliant with requirements, objectives and/or contracts.
- Reviews software systems design, change specifications, and plans against contractual and/or process requirements.
- Reviews include applicable specifications, materials, tools, techniques, and methodologies.
- Provides or directs verification and validation of software system requirements, traceability, and testability.
Now Requirements list (Must Have):
- Computer and software validation
- Change control of Medical Devices
- Understanding of, and/or experience with, medical device regulations, including EU MDR, ISO 13485, and IEC 62304, as well as the changes needed to keep medical devices compliant with new and evolving regulations.
- Understanding of non-medical product development processes and lifecycle requirements.
- Serve as the voice of the Software Systems function on deliverables, providing guidance to cross-functional team members from a software and systems perspective.
- Expertise in training development and delivery.
- Broad understanding of how medical devices are developed, regulated, and approved in the European Union and the United States.
- Familiarity with, or the ability to quickly learn, evolving medical device regulations, including emerging AI-related standards and requirements.
- Expert-level process development skills, with the ability to create quality system documents for a wide range of users and product types, including software and AI-enabled applications
- Advanced understanding of design controls, quality system regulations, and failure investigation process and methodologies.
- Apply knowledge of design control principles and quality engineering techniques throughout the product development process.
- Can provide instruction and guidance of processes and procedures
- Defect analysis skills
- Design and implementation of quality testing and validation tools
- Development and implementation of processes and procedures
Now Skills list (Nice to Have):
- 1-3 years of medical/clinical experience or exposure
- 2 years Medical Device experience
- Agile QMS
- Experience in Cloud Based Software
- NC/CAPA
Now Benefits paragraph: "No PTO, no traditional benefits; ACA-compliant supplemental package available for enrollment."
Pay paragraph: "$45.00 - $55.
About the role
Primary Talent Partners has a new contract opening for a Quality Assurance Engineer - Medical Devices with our medical device client in Lafayette, CO. This is a 6-month contract with a potential for extension.
Responsibilities
- ... ...
Requirements
- Computer and software validation ...
Skills
- Nice to Have: 1-3 years of medical/clinical experience or exposure ...
Benefits
No PTO, no traditional benefits; ACA-compliant supplemental package available for enrollment.
Pay:Pay
$45.00 - $55.00/hr; W2 contract.
We should not repeat "no PTO, no Benefits" in Pay because it's already in Benefits. But the original Pay line included that; we can keep Pay just the rate and contract type. However we might lose the "no PTO, no Benefits" info if we only put in Benefits. That's okay because we have Benefits section covering that. Ensure we don't duplicate. Now check for any other info: location Lafayette, CO already in About the role. Contract duration 6-month with potential extension also there. Now ensure we didn't include boilerplate: removed EEO, etc. Now output HTML. Let's craft list items precisely. Responsibilities list: - Develops, modifies, applies, and maintains standards for software systems quality operating methods, processes, and procedures. - Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation. - Defines appropriate measures to ensure product quality. - Develops overall operating criteria to ensure implementation of the software quality program according to project, process and contract requirements and objectives. - Ensures that projects and process control documentation are compliant with requirements, objectives and/or contracts. - Reviews software systems design, change specifications, and plans against contractual and/or process requirements. - Reviews include applicable specifications, materials, tools, techniques, and methodologies. - Provides or directs verification and validation of software system requirements, traceability, and testability. Now Requirements list (Must Have): - Computer and software validation - Change control of Medical Devices - Understanding of, and/or experience with, medical device regulations, including EU MDR, ISO 13485, and IEC 62304, as well as the changes needed to keep medical devices compliant with new and evolving regulations. - Understanding of non-medical product development processes and lifecycle requirements. - Serve as the voice of the Software Systems function on deliverables, providing guidance to cross-functional team members from a software and systems perspective. - Expertise in training development and delivery. - Broad understanding of how medical devices are developed, regulated, and approved in the European Union and the United States. - Familiarity with, or the ability to quickly learn, evolving medical device regulations, including emerging AI-related standards and requirements. - Expert-level process development skills, with the ability to create quality system documents for a wide range of users and product types, including software and AI-enabled applications - Advanced understanding of design controls, quality system regulations, and failure investigation process and methodologies. - Apply knowledge of design control principles and quality engineering techniques throughout the product development process. - Can provide instruction and guidance of processes and procedures - Defect analysis skills - Design and implementation of quality testing and validation tools - Development and implementation of processes and procedures Now Skills list (Nice to Have): - 1-3 years of medical/clinical experience or exposure - 2 years Medical Device experience - Agile QMS - Experience in Cloud Based Software - NC/CAPA Now Benefits paragraph: "No PTO, no traditional benefits; ACA-compliant supplemental package available for enrollment." Pay paragraph: "$45.00 - $55.