Onsite Senior Quality Engineer - Medical Device (12-Month)

Grove Technical Resources, INC; Santa Ana (CA); Sur place; USD 90 000 - 120 000; Plein temps

Résumé du poste

Grove Technical Resources, INC. is seeking a Sr Quality Engineer for a medical device role in Santa Ana, CA.

The position is fully onsite and involves hands-on quality activities in controlled environments, with exposure to animal-origin tissue and cross-functional collaboration with manufacturing and other groups. You will support manufacturing, drive CAPA and risk management, participate in process validation, and ensure compliance with FDA QSR and ISO 13485.

Qualifications

• Bachelor’s degree in Engineering, Science, or a related technical field.
• 4+ years of experience in Quality Engineering in the medical device or regulated industry.
• Experience with Nonconformance material reports, CAPAs, and FMEA.
• Able to work with Bovine and Porcine tissue.
• Working knowledge of FDA regulations and ISO 13485.

Responsabilités

• Provide quality engineering support for manufacturing, sustaining, and new product introduction.
• Participate in daily manufacturing tier meetings to support production and quality concerns.
• Be present in controlled environment areas/clean rooms to monitor processes and ensure compliance.
• Investigate product non-conformances and implement CAPA.
• Lead or participate in process validation activities (IQ/OQ/PQ).
• Lead or support internal and external audits.

Connaissances

CAPA & FMEA

Team collaboration

Quality exp 4+ yrs

Formation

Bachelor's degree in Engineering/Science

Description du poste

Grove Technical Resources, INC. is seeking a Sr Quality Engineer for a medical device role in Santa Ana, CA.

The position is fully onsite and involves hands-on quality activities in controlled environments, with exposure to animal-origin tissue and cross-functional collaboration with manufacturing and other groups. You will support manufacturing, drive CAPA and risk management, participate in process validation, and ensure compliance with FDA QSR and ISO 13485.