Senior Engineer, Operations Quality
About The Position
Advanced Bionics is seeking a Senior Engineer, Operations Quality to support compliance, manufacturing quality, and operational excellence for implant and external products. This role is responsible for ensuring Manufacturing Controls are compliant with procedures, regulatory requirements, internal standards, and international standards, including 21 CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR. This role partners closely with Manufacturing, Operations, Quality Control, Supplier Quality, Receiving Inspection, Engineering, Clinical, Regulatory, and cross-functional teams to help ensure products meet quality, regulatory, and performance expectations.
Requirements
- Bachelor’s degree in Engineering required, or Associate’s degree in Engineering with 7 years of equivalent work experience
- Minimum of 5 years of Quality Engineering experience in medical device manufacturing required
- Strong knowledge of quality practices, regulatory requirements, and manufacturing controls in a medical device environment
- Ability to coach, mentor, and lead engineers without formal authority
- Strong communication, professionalism, collaboration, and cross-functional partnership skills
- Microsoft Office and engineering software experience required
Nice To Haves
- Class III active implantable medical device experience preferred
- Experience with project management, root cause analysis, process improvement, Six Sigma techniques, or advanced statistical analysis preferred
- Agile PLM, SAP, Minitab, and CAD or solid modeling experience preferred
Responsibilities
- Manage Manufacturing Quality Assurance activities for multiple related projects to ensure alignment with strategic objectives
- Partner with Receiving Inspection, Quality Control, Supplier Quality, Manufacturing, and Operations to support a streamlined manufacturing process
- Support third-party audits related to manufacturing processes, procedures, and policies
- Provide status reporting on manufacturing process deliverables, dependencies, risks, and issues
- Provide expertise on international standards including ISO 13485, ISO 14971, 21 CFR 820, MDSAP, and EU MDR
- Support design transfer, IQ, OQ, PQ, verification, validation, tooling, and manufacturing process testing activities
- Participate in investigations and dispositions related to nonconformances, CAPA, NCMR, MRB, product changes, and root cause analysis
Benefits
- Medical, dental and vision coverage
- Health Savings, Health Reimbursement, Flexible Spending/Dependent Care Accounts
- TeleHealth options
- 401k plan with company match
- Company paid life/ad&d insurance
- Additional supplemental life/ad&d coverage available
- Company paid Short/Long-Term Disability coverage (STD/LTD)
- STD LTD Buy-ups available
- Accident/Hospital Indemnity coverage
- Legal/ID Theft Assistance
- PTO (or sick and vacation time), floating Diversity Day, & paid holidays
- Paid parental bonding leave
- Employee Assistance Program (24/7 mental health support hotline, 5 company paid counseling sessions and more)
- Robust Internal Career Growth opportunities
- Tuition reimbursement
- Hearing aid discount for employees and family
- Internal social recognition platform
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What This Job Offers
Job Type
Full-time
Career Level
Senior
