Quality System Specialist (MedTech)

Location: Milpitas, California, United States

Salary: $75,000–$120,750 per year

Company

Johnson & Johnson MedTech develops healthcare and medical device solutions across the spectrum of patient care.

What you will do

• Support the administration, monitoring, maintenance, and continuous improvement of the Quality Management System.
• Prepare quality metrics, dashboards, trend analyses, performance reports, and Quality Management System Review materials.
• Coordinate Nonconformance, CAPA, Change Control, investigations, root cause analysis, action tracking, and effectiveness verification.
• Administer document control and records management, including review, approval, release, revision, retention, and archival.
• Support internal, external, supplier, and regulatory audits, inspection readiness, remediation, and closure of findings.
• Collaborate with Quality, Regulatory Affairs, Engineering, Manufacturing, Operations, R&D, Supply Chain, Service, and IT on QMS improvement initiatives.

Requirements

• Bachelor’s degree or equivalent in a scientific, engineering, business, or related discipline.
• 2–5 years of experience in Quality Assurance, Regulatory Compliance, or related functions within a regulated industry.
• Working knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, MDSAP, and related quality system requirements.
• Understanding of CAPA, Change Control, Document Control, Training, Risk Management, and Audit processes.
• Strong analytical, problem-solving, project management, organization, prioritization, communication, and presentation skills.
• Ability to work independently and collaborate effectively across functions in a fast-paced environment.

Nice to have

• Medical device industry experience.
• Experience in FDA-regulated or ISO 13485 environments.
• Experience with electronic Quality Management Systems, Agile PLM, SAP, ETQ, ComplianceWire, or similar systems.
• Experience supporting Nonconformance, CAPA, Change Control, Audit Management, and Document Control processes.

Culture & Benefits

• Inclusive work environment focused on diversity, dignity, and equal opportunity.
• Eligibility for pension and 401(k) savings plans.
• Vacation, sick time, holiday pay, personal and family time, parental leave, bereavement leave, caregiver leave, volunteer leave, and military spouse time off.