About the Role
We are seeking an experienced Senior Quality Engineer to support NPI projects and ongoing process revalidation, with a focus on customer specifications, process risk management, validation master planning, and protocol reviews.
Key Responsibilities:
* Review and approve qualification and/or validation documentation, including specifications, protocols, and reports, for instruments, equipment, facilities, utilities, automated systems, manufacturing processes, and cleaning processes during FAT, SAT, IQ, OQ, and PQ phases.
* Review validation documentation (protocols & reports) to ensure they align with the signed-off Validation Master Plan (VMP) and customer requirements.
* Support the development of a Risk Management Plan with the Program Manager, covering quality, timeline, and commercial risks.
* Facilitate equipment process and Design FMEA, ensuring SMEs are trained in the FMEA process and updated on relevant FMEAs as needed.
* Contribute to the development of the Risk Summary Report (RSR) before completing the validation summary report.
* Support Test Method Validation activities and computer systems validation efforts.
* Participate in the review and disposition of quality attribute and variable data for the program against customer specifications (e.g., Ppk's, Cpk's, FOT/FAT visual inspections).
* Lead investigations into material/product issues encountered throughout the development/validation lifecycle, ensuring root cause analysis, containment/corrective actions, and preventive measures are implemented.
* Drive the closure of change control, deviations, and quality continuous improvements identified during the project.
* Ensure customer-related problems/issues are communicated effectively and that corrective actions are implemented and closed in a timely manner.
* Prepare data and presentations for quality review meetings with the customer.
* Support Process Output activities (e.g., MSS, QSS, PSS) and review and approve operational procedures.
* Set up quality controls for a smooth handover to Operations (e.g., defect library and QSS during OQ, incoming material inspections).
* Implement best practices principles in the company's quality management systems as applicable.
* Assist in internal and supplier audits, and play a key role in the preparation and hosting of third-party and customer audits.
* Trend and track quality data (e.g., sampling data, material review reports, project protocols) to drive improvements.
Requirements:
* A minimum of a degree in Engineering, Quality, or Science.
* At least 3 years' post-graduate experience working in a high-volume manufacturing environment, ideally in the Medical Device/Pharmaceutical sector.
* In-depth knowledge of ISO 13485 and 21 CFR Part 820 quality systems.
* A solid understanding of validations in the medical device industry.
* A good understanding of plastic process manufacturing.
* Strong experience with computer system validation.
* Proficient in statistics, SPC, and ideally Minitab.
* Excellent written and oral communication skills.
* Auditing experience (ISO 13485 / 21 CFR Part 820) preferred.
* Strong organizational skills with the ability to prioritize tasks.