Senior Quality Engineer – Santa Clara, CA - $150k - $160k

No C2C

Join an innovative leader in the cardiovascular medical device industry. Founded in 2005, this forward-thinking company specialises in integrated solutions designed to improve patient outcomes in vascular treatments. Their portfolio includes advanced carotid PTA balloon systems with embolic protection, peripheral balloon angioplasty systems, and cutting-edge thrombectomy devices.

Position Overview:

Could you be the next Senior Quality Engineering professional to join my client’s dynamic team? As a Senior Quality Engineer , you will be an integral part of a dynamic team, driving quality initiatives across the entire product lifecycle. With a primary focus on manufacturing and commercialization, your work will directly support the development and delivery of life-saving cardiovascular treatments.

Key Responsibilities:

• Lead quality aspects of complaint investigations, CAPAs, and nonconformance.
• Partner with Manufacturing Engineering to improve yield, reduce costs, and optimize supply chains, ensuring all performance requirements are met or enhanced.
• Support product development activities, including design control, risk management, sterilization, biocompatibility, and design transfer/process validation.
• Oversee manufacturing quality activities at contract manufacturers, ensuring compliance with product specifications and regulatory requirements.
• Develop and review test protocols and reports for design verification and process validation.
• Proactively ensure compliance with ISO 13485, 21 CFR 820, and other applicable quality standards and regulations.
• Contribute to risk management activities, including DFMEA, PFMEA, and product biological risk assessments.
• Use post-market data to enhance risk management programs and support failure investigations.
• Assist in supplier qualification, internal audits, and third-party audit preparations.
• Provide insights and metrics for management review.

Qualifications:

• Bachelor’s degree in engineering or a related field.
• 5+ years of experience in the medical device industry, with a focus on quality engineering and design.
• Strong understanding of ISO 13485, ISO 14971, and 21 CFR 820.
• Skilled in risk evaluation and decision-making.
• Proficient in interpreting technical documentation and mechanical drawings.
• Professional and collaborative team player with excellent interpersonal skills.