Director, QA/RA
# Director, QA/RA **TRIFECTA MEDICAL LLC** · Plainfield, IN 46168 · `On-site` 🕒 **Статус:** *Опубликовано: сегодня* · *Источник: Indeed* --- ### About the Role Title: Quality & Regulatory Affairs Manager Position summary Trifecta 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. Pay: $80,000.00 - $110,000.00 per year Benefits: 401(k) Dental insurance Health insurance Health savings account Life insurance Paid time off Referral program Vision insurance Work Location: In person
Наблюдалась 2026-09-21, впервые 2026-09-21, источник — Indeed.