Zimmer BiometRemote
Quality Sr Engineer II
United States of America
Full Time
3 weeks ago
$89,000 - $112,000 USD
H1B Sponsor Likely
Key skills
Design controlsVerification and validationFDA 21 CFR 820.30ISO 13485EU MDRRisk managementISO 14971FMEAStatistical analysisCAPARoot cause analysisQuality Management SystemsDesign History FilesRisk Management FilesSupplier quality managementCustomer complaint investigationContinuous improvementV&V planning and executionHuman factors usability studiesWindchillCodebeamerJiraMicrosoft OfficeMinitabCQE certificationCRE certificationMaterials scienceRoboticsSiMDSaMDSix Sigma Black BeltDOE proficiencyQSIT Lead Auditor CertificationCoaching and mentoringStatistical AnalysisRisk Management
About this role
Zimmer Biomet is a global medical technology leader committed to enhancing patient mobility. They are seeking a Senior Quality Engineer II to ensure compliance with regulatory standards, drive quality initiatives, and collaborate across teams to deliver innovative medical technology.
Responsibilities:
- Works as part of a team and individually, completing Quality tasks in the design and development, and change control processes
- Coaches and mentors less experienced peers
- Reviewer and approver of document-controlled forms
- Leads team member training
- Serves as site SME for multiple processes
- Represents Quality team in global and site meetings
- Creates project and resource plans for medium scale, moderate complexity projects
- Ensure compliance with global regulations and recognized standards (e.g., FDA 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR)
- Review, maintain and approve Design History Files (DHF) and Risk Management Files (RMF)
- Identify and mitigate design risks using FMEA and other tools
- Support design verification and validation activities
- Supports design and change control processes
- Collaborate with design teams to embed quality standards
- Author, review and approve documentation in Quality capacity
- Define and control Critical to Quality (CTQ) characteristics
- Assist with regulatory submissions and audits
- Analyze quality data to identify trends and improvement areas
- Support quality improvement initiatives
- Support root cause investigations and CAPA activities
- Supports design transfer and sourcing transfers with Supplier Quality counterparts
- Supports customer complaints investigations
Requirements:
- Bachelor's Degree in Engineering and 5 years of relevant experience or equivalent experience
- Proficient in design controls, verification, validation (design, process and software)
- Experienced with FDA 21 CFR 820.30, ISO 13485, EU MDR and other global regulations
- Skilled in risk management (ISO 14971, FMEA, statistical tools)
- Strong QMS knowledge and continuous improvement focus
- Capable in V&V planning and execution including human factors usability studies
- Proficient in statistical analysis data analysis
- Experienced in CAPA, root cause analysis, and quality improvement
- Skilled in technical documentation (DHF, test plans, specs)
- Effective cross-functional communicator
- Excellent technical writing skills
- CQE or CRE certification preferred
- Solid foundation in engineering principles; preferred expertise in materials science, robotics, SiMD, and SaMD
- Six Sigma Black Belt, DOE Proficiency Preferred
- QSIT Lead Auditor Certification Preferred
- IT System Skills (Preferred): Windchill, Codebeamer, Jira, Microsoft Office, Minitab