Katalyst CRO ยท 1 week ago
Design Quality Engineer
Winchester, VA
Contract
Onsite
Mid LevelKatalyst Healthcares & Life Sciences is seeking a Design Quality Engineer to ensure compliance with design control standards and support quality assurance processes. The role involves collaborating with engineering teams, overseeing design verification and validation, and ensuring adherence to regulatory requirements.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Collaborate with design engineering to develop, review, and approve Design Inputs/Outputs, Design History File (DHF) documentation, and Change Control implementation
Ensure full compliance with design control standards such as 21 CFR 820 and ISO 13485
Act as SME for design controls, design verification & validation (V&V), process validation, test method validation (TMV), and risk management per ISO 14971
Plan and execute risk management activities including hazard analysis, dFMEA, and pFMEA throughout the product lifecycle
Conduct Failure Modes and Effects Analysis (FMEA) and integrate findings into design and manufacturing processes
Lead or support design verification and validation planning, execution, protocol creation, and report writing
Oversee test method validation, statistical testing, and process validation to ensure traceability and compliance
Develop, revise, and ensure adherence to QMS procedures covering ISO 13485, cGMP, and 21 CFR Part 820, including document control, CAPA, and audit readiness
Support internal and supplier audits, regulatory inspections, and ensure follow-up with corrective actions
Investigate product deviations and process non-conformances, lead root cause analysis, and implement CAPA or Client actions
Monitor the effectiveness of corrective actions and maintain relevant documentation
Qualify suppliers, review supplier documentation, and support pilot/production transfer to align with Critical to Quality (CTQ) requirements
Collaborate with manufacturing engineering to implement process improvements and validate manufacturing outputs
Stay current with relevant regulations (FDA, EU MDR, ISO 10993, etc.) and integrate best practices into quality systems
Provide regulatory submission support for 510(k) or similar filings
Educate engineering and manufacturing teams on design and quality requirements, quality tools, and compliance standards
Qualification
Required
Collaborate with design engineering to develop, review, and approve Design Inputs/Outputs, Design History File (DHF) documentation, and Change Control implementation
Ensure full compliance with design control standards such as 21 CFR 820 and ISO 13485
Act as SME for design controls, design verification & validation (V&V), process validation, test method validation (TMV), and risk management per ISO 14971
Plan and execute risk management activities including hazard analysis, dFMEA, and pFMEA throughout the product lifecycle
Conduct Failure Modes and Effects Analysis (FMEA) and integrate findings into design and manufacturing processes
Lead or support design verification and validation planning, execution, protocol creation, and report writing
Oversee test method validation, statistical testing, and process validation to ensure traceability and compliance
Develop, revise, and ensure adherence to QMS procedures covering ISO 13485, cGMP, and 21 CFR Part 820, including document control, CAPA, and audit readiness
Support internal and supplier audits, regulatory inspections, and ensure follow-up with corrective actions
Investigate product deviations and process non-conformances, lead root cause analysis, and implement CAPA or Client actions
Monitor the effectiveness of corrective actions and maintain relevant documentation
Qualify suppliers, review supplier documentation, and support pilot/production transfer to align with Critical to Quality (CTQ) requirements
Collaborate with manufacturing engineering to implement process improvements and validate manufacturing outputs
Stay current with relevant regulations (FDA, EU MDR, ISO 10993, etc.) and integrate best practices into quality systems
Provide regulatory submission support for 510(k) or similar filings
Educate engineering and manufacturing teams on design and quality requirements, quality tools, and compliance standards
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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