Staff Quality Engineer
About The Position
Sarmal is hiring a Staff Quality Engineer to build and run our quality management system hands-on as we bring molecular assay, consumables, and instrument programs from concept through design transfer and commercialization. This is a full-time, individual-contributor role within Operations, reporting directly into company leadership, with no existing quality staff or precedent to lean on — you will write the procedures, train the team on them, audit against them, and revise what doesn't work. You will own design control and Design History Files across multiple concurrent programs, lead ISO 14971 risk management, implement and administer our eQMS, run CAPA and nonconformance to closure, qualify suppliers and CDMO partners, and drive process and software validation — right-sizing every control to a 30–50 person organization without leaving audit exposure.
Requirements
- Working command of FDA QMSR (21 CFR 820), ISO 13485:2016, ISO 9001:2015, ISO 14971, and cGMP.
- ASQ Certified Quality Engineer (CQE) or equivalent certification.
- Sound applied statistics for quality engineering: sampling plans, process capability, gage R&R, and method validation — able to defend the rationale, not just execute the protocol.
- Familiarity with IEC 62304 and premarket cybersecurity documentation preferred.
- Sufficient technical depth across molecular/genomics, assay chemistry, or instrumentation to review technical data and credibly challenge conclusions.
- 10+ years of quality experience in medical device or IVD product development and commercialization, with demonstrated progression across multiple quality functions.
- Hands-on experience building or substantially rebuilding a quality system — document control, design control, CAPA, supplier controls — rather than solely operating within an established one.
- Demonstrated ownership of a Design History File through at least one product from concept to design transfer or launch.
- Process validation experience (IQ/OQ/PQ) with sound applied statistics, including DOE familiarity.
- A builder's mindset: comfortable operating without support staff or precedent, with the pragmatic judgment to right-size controls and the credible independence to hold the line with engineering, R&D, and executive stakeholders on the things that matter most.
Responsibilities
- Design control & DHF ownership — own Design History Files across multiple molecular assay, consumables, and instrument programs from concept through design transfer.
- Risk management — own ISO 14971 risk management files, hazard analysis, dFMEA/pFMEA/uFMEA, risk control verification, and benefit-risk rationale, feeding directly into design and process decisions.
- eQMS implementation & administration — select, implement, and administer the electronic quality management system as the backbone of document control and quality records.
- CAPA, nonconformance & deviation management — own the full loop: investigation, root cause, corrective/preventive action, effectiveness checks, and trending into management review.
- Supplier quality & purchasing controls — qualify and monitor critical suppliers, CDMO partners, and OEM chemistry sources; own incoming inspection criteria and supplier corrective actions.
- Validation — lead process validation (IQ/OQ/PQ) with defensible statistical rationale; support assay, consumables, instrument, and software validation, including computer system validation under an SDLC framework.
- Audit & certification readiness — run the internal audit program; prepare for and support notified body, supplier, and regulatory audits; drive the system toward ISO 13485 certification and IVDR technical documentation readiness.
Benefits
- Medical, dental, and vision coverage
- Company-paid life insurance
- 401(k) retirement plan
- Generous paid time off
- Access to additional voluntary benefits, employee perks, and discount programs
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
