Job Description
We are seeking an experienced Senior Quality Engineer to support NPI (New Product Introduction) projects and ongoing process revalidation.
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.
* 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.
* Lead investigations into material/product issues encountered throughout the development/validation lifecycle, ensuring root cause analysis, containment/corrective actions, and preventive measures are implemented.
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.
Travel and Physical Requirements
* Must be able to travel up to 5% of the time.
* 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.
About Us
The company is committed to delivering high-quality products that meet customer specifications and regulatory requirements. We strive to maintain a safe and healthy work environment and promote a culture of continuous improvement.