What are the responsibilities and job description for the Senior Quality Engineer position at ACE Partners?
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 :
Salary : $150,000 - $160,000
