Sr Design Quality Engineer

Sr Quality Engineer – Medical Device

Job Title: Sr Quality Engineer – Medical Device

Job Location: Northridge, California (Fully Onsite)

Employment Type: W2 contract

Duration: 12 months

• Design Control and Regulatory Experience (ISO 13485, 21 CFR 820, EU-MDR, MDD)
• Risk Management and Validation Proficiency
• Implantable / Electro-Mechanical Device Experience

• 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, meet/exceed deadlines and hold 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

Minimum Experience: 3 years of work experience

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.

Identify and implement effective process control systems to support the development, qualification, and ongoing 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.

Detailed knowledge of FDA 21

CFR 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.

Mid‑Senior level

Contract

Quality Assurance

Medical Equipment Manufacturing and Engineering Services