Role details

Contract type

Permanent contract

Employment type

Full-time (> 32 hours)

Experience level

Expert

Experience required

8 years minimum

Working hours

Regular working hours

Job source

www.disabledperson.com

Tech stack

Failure Mode Effects Analysis Verification and Validation (Software) Iq/oq/pq Model Validation

Job description

• Own Design History Files and design control across multiple assay, consumable and instrument programs
• Lead ISO 14971 risk management, including hazard analysis, design/process/use FMEAs, and risk control verification
• Select, implement and administer the company’s electronic QMS
• Run CAPA, nonconformance and deviation management end to end, from root cause to effectiveness checks
• Qualify and monitor suppliers, CDMOs and OEM partners, including incoming inspection and supplier corrective actions
• Lead process validation (IQ/OQ/PQ) and support assay, instrument and software validation
• Build the internal audit program and drive toward ISO 13485 certification and IVDR readiness

Requirements

• 8-10+ years of quality experience within IVD product development and commercialization
• Experience building or substantially rebuilding a quality system, not just operating within one
• Ownership of a Design History File for at least one product from concept to design transfer or launch
• Working command of 21 CFR 820 (QMSR), ISO 13485, ISO 14971 and cGMP
• Strong applied statistics: sampling plans, process capability, gage R&R, method validation and DOE
• ASQ CQE certification or equivalent
• Enough technical depth in molecular, assay chemistry or instrumentation to credibly challenge data
• Bonus: IEC 62304 and premarket cybersecurity experience

Apply for this position

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Apply on www.disabledperson.com

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