Senior QSAT Engineer

The Senior QSAT Engineer is a technical quality engineering role within the Quality Science and Technology (QSAT) Sustain organization. This position is primarily responsible for leading complex product quality investigations throughout the product lifecycle to ensure patient safety, regulatory compliance, product reliability, and continuous improvement.

The successful candidate will serve as the Quality Engineering lead for product investigations arising from complaints, post-market surveillance, manufacturing events, field actions, and product quality trends. This role is expected to independently drive robust root cause investigations, risk assessments, and corrective actions while partnering closely with Manufacturing, R&D, Technical Support, MSAT, Regulatory Affairs, Post-Market Surveillance, and Manufacturing Quality.

Primary Responsibilities

• Lead complex product investigations resulting from customer complaints, post-market surveillance, field actions, manufacturing events, product quality trends, and nonconformances.

• Perform and facilitate structured root cause investigations using established problem-solving methodologies (5 Whys, Fishbone, Fault Tree Analysis, Kepner-Tregoe, DMAIC, etc.).

• Drive timely completion of CAPAs, nonconformance investigations, effectiveness checks, and associated quality records.

• Evaluate product and process risks using ISO 14971 risk management principles and support updates to risk management documentation.

• Partner with Manufacturing, MSAT, R&D, Regulatory Affairs, Technical Support, and Quality organizations to resolve complex technical and quality issues.  

• Support sustaining engineering activities, including design changes, engineering change orders, and lifecycle management activities.

• Provide Quality Engineering oversight for Design Controls, Design Verification & Validation (V&V), Design Transfer, and manufacturing process validation activities.

• Review and approve validation documentation, engineering studies, protocols, reports, and qualification activities to ensure regulatory compliance.

• Support Equipment Qualification (IQ/OQ/PQ), software validation, process validation, method validation, and manufacturing changes, as applicable.

• Analyze complaint, field, and manufacturing data to identify systemic trends and recommend product and process improvements.

• Ensure compliance with internal Quality Management System requirements and applicable global regulations.

• Serve as a technical resource during internal and external regulatory inspections and quality audits.

• Mentor junior engineers and contribute to continuous improvement initiatives within the QSAT organization.

• Perform other duties as assigned.

• Bachelor's degree in Engineering or related scientific discipline.

• Minimum 8 years of Quality Engineering experience within the medical device or in vitro diagnostics (IVD) industry.

• Demonstrated experience leading complex product investigations from initiation through closure.

• Strong experience performing Root Cause Analysis (RCA), CAPA, Nonconformance, and Product Investigation activities.

• Experience supporting Design Verification & Validation (V&V) and Design Transfer activities.

• Experience supporting process validation, equipment qualification, software validation, and manufacturing changes.

• Working knowledge of:

  • ISO 13485

  • FDA 21 CFR Part 820 / Quality Management System Regulation (QMSR)

  • ISO 14971 Risk Management

  • Good Documentation Practices (GDP)

• Experience applying risk management tools including FMEA and Hazard Analysis.

• Demonstrated ability to independently assess technical data and make quality-based decisions.

• Excellent written and verbal communication skills.

• Ability to influence cross-functional teams without direct authority.

Preferred Qualifications

• ASQ Certified Quality Engineer (CQE) or equivalent certification.

• Experience with IVD, pathology, molecular diagnostics, or life science instrumentation.

• Experience supporting FDA, ISO 13485, MDSAP, or Notified Body inspections.

• Lean Six Sigma Green Belt or Black Belt.

• Experience with statistical analysis and trending tools (Minitab or equivalent).