Manager, QA/RA

Medical is an ISO 13485:2016 certified contract manufacturer of sterilization cases, trays, and instrument caddies for the orthopedic and surgical device market. The Quality & Regulatory Affairs Manager owns day-to-day operation of the quality management system and serves as the primary quality contact for customers, suppliers, and external auditors. This is a hands-on role in a lean organization — you will write the procedure, run the audit, and close the CAPA yourself.

Required qualifications

• Bachelor's degree in engineering, life sciences, Biomedical Science, Business Management, or a related technical field (equivalent experience considered in lieu of degree)
• 3+ years in quality assurance within a medical device or other FDA-regulated manufacturing environment , including at least 2 years with direct QMS ownership or supervisory responsibility
• Working, hands-on knowledge of ISO 13485:2016 and 21 CFR Part 820 / QMSR
• Demonstrated experience owning core QMS processes: CAPA, nonconforming material, internal audit, document and change control, training records, management review
• Experience hosting or directly supporting external audits (notified body, registrar, FDA, or customer)
• Experience with supplier qualification, supplier quality agreements, and supplier corrective action requests (SCARs)
• Ability to read engineering drawings and apply GD&T ; comfortable with basic inspection methods and measurement equipment
• Strong technical writing — procedures, work instructions, audit responses, and customer-facing corrective action reports
• Proficient in Excel and an ERP/MRP system

Preferred qualifications

• Experience at a contract manufacturer (multi-customer, multi-part environment) rather than a single-product OEM
• Certified Quality Auditor ( CQA ), Certified Quality Engineer ( CQE ), or ISO 13485 Lead Auditor certification
• Familiarity with 21 CFR Part 11 and validation of electronic records/electronic signatures
• Experience writing and executing IQ/OQ/PQ protocols for manufacturing equipment and processes
• Working knowledge of EU MDR , UDI/GUDID, and FDA establishment registration and device listing
• Exposure to sterile barrier / sterilization case and tray product families, or metal fabrication processes (laser, turret punch, welding, silk screen, sublimation, passivation)
• Experience with JobBoss or a comparable job-shop ERP
• Statistical sampling plans (ANSI/ASQ Z1.4), basic SPC, MSA/gage R&R

Core responsibilities

• Maintain and continuously improve the ISO 13485:2016 quality management system; own the document control and change control processes.
• Manage the internal audit program — schedule, conduct, report, and drive closure of findings.
• Own CAPA and nonconforming product processes end to end, including root cause investigation and effectiveness verification.
• Serve as primary quality contact for customer complaints, SCARs, and customer audits; write and defend formal responses.
• Host registrar/notified-body surveillance and recertification audits.
• Run supplier qualification, monitoring, requalification, and quality agreements.
• Support regulatory activities: registrations and listings, UDI submissions, labeling review, and technical file/DHF support as applicable.
• Author and execute validation protocols (IQ/OQ/PQ) for new equipment and processes; manage revalidation.
• Prepare quality metrics and lead management review.
• Train production and inspection personnel on quality requirements and maintain training records.

Success in the first 12 months

• 90 days: fully independent on document control, NCM disposition, and receiving/final inspection escalations.
• 6 months: running the internal audit schedule and CAPA program without oversight.
• 12 months: leading the registrar surveillance audit as the primary host.