What are the responsibilities and job description for the Senior Quality Engineer position at Grove Technical Resources, INC?
Job Title: Sr Quality Engineer – Medical Device
Job Location: Northridge, California (Fully Onsite)
Type: W2 contract
Duration: 12 months
Must-Have:
1. Design Control and Regulatory Experience (ISO 13485, 21 CFR 820, EU-MDR, MDD)
2. Risk Management and Validation Proficiency
3. Implantable / Electro-Mechanical Device Experience
Seeking a highly experienced Quality Engineer to provide crucial quality engineering support throughout the product development lifecycle for complex implantable / electro-mechanical medical devices. The ideal candidate will possess detailed knowledge of FDA 21CFR 820, ISO 13485, and ISO 14971 to ensure full compliance with design control principles and global medical device regulations like EU-MDR. This role demands serving as a Subject Matter Expert for Risk Management (Hazards Analysis, FMEAs), leading design verification and validation testing, and executing process validations (TMV, IQ/OQ/PQ). Furthermore, the role involves supporting design transfer, supplier qualifications, continuous improvement initiatives, and utilizing sound problem-solving methodologies to resolve quality issues, requiring the ability to author comprehensive technical documentation.
Good to Haves:
Working knowledge of IEC 62304 and IEC 60601-1.
Ability to drive process improvement activities.
ASQ Certification in Quality or Reliability.
Ability to multi-task, prioritize, meets/exceed deadlines and holds themselves, and others accountable.
Education Required:
Bachelor’s degree in engineering or science with 5 years of work experience in Quality and/or Engineering OR master’s degree in engineering or science with 3 years of work experience in Quality and/or Engineering
Years’ Experience Required: Minimum 3 years of work experience
Essential Functions and Responsibilities
Provide quality engineering support throughout the product development lifecycle by applying ISO 13485, ISO 14971, and FDA design control principles to ensure compliance.
Serve as a Subject Matter Expert and own Risk Management (Hazards Analysis and FMEAs) across the assigned product / product families (mainly complex electro-mechanical devices).
Support design verification, validation, and reliability testing.
Participate in supplier qualifications.
Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements, supporting design transfer activities.
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Support audits, CAPA investigations, and continuous improvement initiatives.
Must Haves / Minimum Requirements:
Detailed knowledge of FDA 21CFR 820, GMP, MDD and EU-MDR, and ISO 13485 and ISO 14971.
Engineering and technical experience and demonstrated use of Quality tools/methodologies.
Experience with planning and executing design verification testing, test method development and test method validation (hands on execution experience preferred)
Ability to author technical reports, business correspondence and standard operating procedures.
Experience with planning and executing process validations (TMV, IQ/OQ/PQ) including authoring of Master Validation Plans and Reports.
