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Design Assurance, Quality Engineer
Minor Hotels Europe and AmericasDesign Assurance Engineer leading product development tasks in medical devices for Heraeus. Responsible for ensuring compliance and quality within design and manufacturing processes.
About the role
Key responsibilities & impact- Lead and implement product development, including the application of design controls, for new products and existing product changes including line extensions.
- Create and maintain the design history file (DHF), including development of related specifications such as user requirements and design specifications.
- Plan, implement, and report on design verification and validation studies, including bench and pre-clinical test protocols and reports.
- Lead the development of manufacturing documentation and manufacturing process validation activities.
- Responsible for risk management activities from product concept through commercialization.
- Partner with Regulatory to support submissions for pre-market authorizations in the US.
- Work closely with contract manufacturers and other suppliers to implement new projects and ensure supply chain meets performance and quality requirements.
- Perform lot release, including reviewing batch records, device history records (DHRs), and process documentation for accuracy and completeness.
- Support the intake, evaluation, and documentation of nonconforming materials.
- Support post-market phase including product complaint handling, risk management, and post-market surveillance activities.
- Help conduct supplier qualification and performance evaluation activities.
- Communicate quality issues to suppliers and support resolution tasks.
- Assist with internal audits and support external audits and inspections (e.g., FDA, ISO).
Requirements
What you’ll need- Bachelor’s degree in life sciences, material sciences, engineering or a related field required.
- Experience in medical device industry required; minimum 3 years preferred.
- Working knowledge of design controls and general knowledge of the ISO 13485 standard; formal ISO 13485 training is a plus.
- Experience in a small company or start-up environment preferred.
- Experience with QMS support software / document control systems is a plus.
Benefits
Comp & perks- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Remote work options
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
product developmentdesign controlsdesign verificationdesign validationmanufacturing documentationrisk managementlot releasenonconforming materials evaluationpost-market surveillancesupplier qualification
Soft Skills
communicationleadershipcollaborationproblem-solvingorganizational skills
Certifications
ISO 13485 training