Quality Engineer II
Responsibilities may include the following and other duties may be assigned:
- Ensure legacy design documentation is accurately migrated and aligned with current Medtronic templates and standards
- Ensure DHF & risk management files alignment with design control requirements and internal quality procedures.
- Review, assess, and remediate legacy DHFs (including risk management to ensure completeness and compliance with regulatory requirements (e. g. FDA, EU MDR).
- Participate with cross-functional teams to review DHF files & technical files, identify gaps & drive remediation with respect to standards such as FDA 21 CFR 820, ISO 13485, ISO 14971 and EU MDR.
- Revise or create documentation related to design controls, risk management, verification and validation, design reviews and change management.
- Assist in the creation of verification and validation plans, protocol and reports. Oversee testing and analysis for standards and product requirements compliance.
- Identify gaps in design documentation including requirements, verification/validation, traceability and design reviews.
- Develop product risk management file (risk management plan, risk assessments, DFMEA and risk management report) as per ISO 14971 standard and internal procedures.
- Ensure complete bidirectional traceability from user needs through design inputs, outputs, V&V, and risk controls.
- Establish clear traceability between hazards, harms, hazardous situations, and mitigations in risk management files.
- Deep understanding of Change Development Process and structured change management systems.
- Comfortable working with international cross functional teams in different time zones.
Required Knowledge and Experience:
- B E or B. Tech in Mechanical/Biomedical engineering
- Minimum 3-5 years of quality engineering experience or equivalence and overall 5-8 years of experience.
- DHF Remediation, Risk Remediation, Gap analysis.
- Previous experience working in a cross-functional team environment and remediation activities.
- Good verbal and written communication skills including protocol / report development and technical presentations.
- Strong in design and development, verification and validation and risk management.
- Good interpersonal skills and ability to work in a fast-paced environment.
Nice to have: - ISO 13485 Internal Auditor / Lead Auditor Certification.
- Experience in Test Method Validation (TMV) including statistical justification and GR&R.
- Strong understanding of statistical tools for validation and sampling rationale.
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