Entry - level Quality Engineer at Celestica, responsible for quality standards in manufacturing processes. Engaging in ISO compliance, supply chain management, and process documentation.
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Staff Quality Engineer – Medical Device, Combination Product
Posted last week
About the role
- Quality Engineer providing hands-on QA support for medical device and combination product development teams. Ensuring compliance with medical device standards and facilitating quality processes from development to launch.
Responsibilities
- Serve as the Quality representative on medical device and combination product development teams from proof-of-concept through clinical readiness and launch.
- Provide proactive guidance on medical device design controls in accordance with 21 CFR 820, ISO 13485, and applicable internal procedures.
- Review and approve design control deliverables including Design Inputs, Design Outputs, Design Reviews, Design Verification and Validation, and Design History File (DHF) documentation.
- Support integration of device constituent quality requirements within combination product development programs (21 CFR Part 4).
- Lead and facilitate risk management activities in accordance with ISO 14971, including hazard analysis, FMEA, system risk assessments, and risk-benefit evaluations.
- Review and approve Risk Management Files and ensure appropriate linkage to design controls and verification/validation activities.
- Support human factors and usability engineering activities, including formative and summative usability studies, as applicable.
- Partner with Device Development and Contract Manufacturing Organizations (CMOs) to support manufacturing process development, characterization, and validation.
- Review and approve manufacturing-related documentation such as manufacturing plans, manufacturing instructions, process FMEAs, process validation protocols and reports.
- Support supplier qualification activities, including supplier audits, quality agreements, and ongoing supplier performance oversight.
- Review, approve, and as needed lead investigations related to deviations, nonconformances, and complaints with impact to medical devices or combination products.
- Lead or support root cause investigations and development of effective CAPAs.
- Contribute to continuous improvement initiatives related to design control processes, risk management practices, and quality system effectiveness.
- Author, review, and revise Quality System procedures related to medical device and combination product development.
- Maintain current knowledge of applicable global regulations and standards, including FDA, ISO, MDR, and MDSAP requirements.
- Support internal audits, supplier audits, and inspection readiness activities as required.
Requirements
- Bachelor’s degree in Engineering, Biomedical Engineering, Life Sciences, or a related scientific discipline AND 8+ years of experience in Quality Assurance supporting medical devices and/or combination products, or equivalent education and years of experience.
- Demonstrated hands-on experience with medical device design controls and Design History File management.
- Strong working knowledge of applicable regulations and standards, including 21 CFR 820, ISO 13485, ISO 14971, and combination product requirements (21 CFR Part 4).
- Experience with quality event management, root cause analysis, and CAPA within a regulated environment.
- Ability to work independently, exercise sound judgment, and communicate effectively with cross-functional stakeholders.
- **Preferred Requirements: **
- Combined experience in pharmaceutical and medical device development environments.
- Master’s degree in Engineering, Life Sciences, or a related field.
- Experience supporting clinical trial readiness and clinical supply release for device or combination products.
- Strong background in risk management across the full product lifecycle, from early development through launch.
- Experience working with CMOs and contract testing laboratories, including audits and quality agreement management.
- Knowledge of statistical methods applied to quality and validation activities.
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