Sr Quality Engineer

Sr Quality Engineer

Medtronic Cardiac and Vascular
5-8 years
Not Specified

Job Description


Must Have
  • Review new and modified product design documentation for quality characteristics,including manufacturability, serviceability, testability, reliability, and product requirements.
  • Ensure that product development projects and changes to existing products are conducted in compliance with FDA Quality System Regulations, EU MDR and inhouse Standards.
  • Participate on cross-functional teams to develop product risk management file (risk management plan, Hazard Analysis, DFMEA, and risk management report) as per ISO 14971.
  • Acts as the subject matter expert on risk management for one or more products/platforms.
  • Previous experience working in a cross-functional team environment.
  • Familiar with statistical software tools (Minitab, Stat Graphics)
  • Familiar with ISO 13485, ISO 14971, IEC 60601 and product specific industry standards.
  • Hands-on experience on EU MDR.
  • Ensure successful transfer of new products to production facility by assisting in the development of process validation requirements (PFMEA, IQ, OQ, PQ) using appropriate statistical tools and techniques.
  • Review Design History Files and Technical Files for conformance to applicable requirements.
  • Assist in creation of verification and validation plans, protocol and reports. Oversee testing and analysis for standards and product requirements compliance.
  • Participate and provide input to training on department / division procedures and policies.
  • Participate when appropriate in audits
  • Independently develop test strategies for new, pre-concept features in development.
  • Provide guidance to junior quality engineers.
  • Develops templates and training based on the quality system regulations, applicable standards and guidance.
  • Independently reviews all deliverables to ensure compliance with development process and the standard.
  • Delivers presentations to the QA organization on status and issues of assigned projects.
    Delivers training to departments outside of QA.
  • Demonstrates ability to effectively play multiple roles on a cross-functional team including contributor, subject matter expert, leader, facilitator.
  • Previous experience working in a cross-functional team environment.
  • Hands-on experience on Risk Management, Design Controls for Medical Devices.

Minimum Qualification
  • B E or B.Tech in Mechanical Engineering
  • Minimum 5-8 years of quality engineering experience or equivalence and overall 8-10 years of experience

Key Technical Competencies
  • Previous experience working in a cross-functional team environment.
  • Familiar with statistical software tools (Minitab, Stat Graphics)
  • Familiar with ISO 9001, ISO 13485, ISO 14971, IEC 60601, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards.
  • Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive.
  • Good verbal and written communication skills including protocol / report development andtechnical presentations.
  • Fair Knowledge in Risk Management
  • Comparative Statistical techniques, sampling plans, GR&R, K-factor, hypothesis testing, ANOVA, parametric and non-parametric analysis.
  • Familiar with DMAIC or DMADV(DFSS) methodologies

Nice to Haves
  • ASQ CQE, CQA, CSQE and/or CRE certification.
  • ISO 9001 Internal Auditor / Lead Auditor Cerification
  • ISO 13485 Internal Auditor / Lead Auditor Cerification
  • Lean Six Sigma Green Belt or Black Belt

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