We are seeking an experienced Senior Quality Engineer to support NPI (New Product Introduction) projects and ongoing process revalidation, with a focus on customer specifications, process risk management, validation master planning, and protocol reviews. This role involves providing technical and quality expertise to manage quality deliverables on selected NPI projects and day-to-day validation activities. You will also coordinate activities to ensure the timely closure of internal and external quality issues on projects.
Essential Duties and 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 the 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.
Basic Qualifications:
- 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.
Preferred Knowledge, Skills, and Abilities:
- Awareness of relevant standard operating procedures related to the position.
- Support and contribute to Lean Sigma programs and activities towards the delivery of set targets.
- Compliance with company safety and quality policies at all times.
Travel Requirements:
- Must be able to travel up to 5% of the time.
Physical and Mental Requirements:
- Physical Requirements: Must be able to exert up to 10lbs/4kg of force occasionally, and/or negligible amounts of force frequently or constantly to move objects.
- Mental Requirements: Must be able to communicate effectively with team members and other departments, make quick decisions, and interpret data accurately.
Additional Responsibilities:
- Perform additional duties as requested by the direct supervisor when necessary.
