Supplier Quality Manager
Sunnyvale, CA, United States
Description
Are you a detail-oriented professional with a passion for quality and continuous improvement? Join our team as the Quality Supplier Manager! This multi-faceted leadership role is responsible for developing product specifications and quality plans, managing supplier qualification and re-qualification documentation, and ensuring compliance with quality management requirements.
Please note – this is an on-site position. Relocation assistance is not available.
Summary of what you will do:
· Lead the qualification and monitoring of suppliers, overseeing the supplier audit program to ensure compliance with company standards and regulatory requirements.
· Define and implement quality improvement parameters for supplied products, collaborating with various departments to resolve CAPAs, NCRs, and complaints.
· Act as the primary owner of CAPAs, conducting thorough root cause investigations and documenting corrective and preventive action plans.
· Collaborate with suppliers to evaluate significant product and process changes, reducing defects, enhancing yields, and optimizing product costs.
· Work with R&D, Operations, Regulatory Affairs, and Sales and Marketing to manage non-conforming materials, documenting non-conformances, root cause analyses, and corrective actions.
· Assess supplier capabilities, identify quality risks, and implement effective mitigation strategies in collaboration with cross-functional teams.
· Partner with Engineering and Operations to ensure suppliers develop and document appropriate test methods and generate comprehensive reports, including statistical analysis.
· Ensure adherence to Quality System Regulation and FDA/MDD regulations, maintaining compliance with company Quality System procedures and policies.
· Cultivate and maintain a professional, credible image with key stakeholders, fostering positive relationships and effective communication.
· Serve as a subject matter expert on supplier quality management, providing guidance and support to internal stakeholders on quality-related issues.
· Maintain compliance with relevant standards for facilities.
· Perform other duties as assigned.
Education & Experience:
· BS in biomedical engineering;
· Can be an equivalent combination of education and professional experience.
Knowledge, Skills, & Abilities:
· Understanding of regulatory requirements for the medical device industry, specifically 21 CFR 820.50, ISO 13485, and EU MDR.
· Proficiency with Microsoft Office suite required. Proficiency with statistical software, such as MiniTab, preferred.
· Ability to work independently, using good judgment, initiative, and analytical abilities, to accomplish short and long-range projects, anticipate likely needs, and recommend actions with minimal direction.
· Ability to work as a team member and ability to be very flexible, adaptable, and to work under pressure.
Salary Range:
$130,000 - $170,000
Base pay is one part of your total compensation. The final starting salary offer to the successful candidate will be determined by evaluating several factors, such as education, experience, knowledge, skills, internal equity, and alignment with market data.
About EBR Systems
Silicon Valley's EBR Systems is revolutionizing cardiac rhythm disease treatment with its WiSE CRT System technology, eliminating the need for pacing leads. Our dedicated team is committed to providing safe, cost-effective wireless cardiac stimulation therapies for millions of patients.
Are you curious, creative, and driven? If you are passionate about healthcare innovation, EBR could be the place for you. We seek candidates who are passionate about improving healthcare and motivated to do the hard and exciting work required to bring a ground-breaking technology to market.
EBR Systems offers a great place to work as well as generous benefits and growth opportunities:
Medical, dental, and vision insurance
401K
PTO – starting at 3 weeks per year
Competitive salary with opportunities for career growth
Employee stock options
Life, AD&D, Long-Term Disability insurance
Weekly company lunches and occasional happy hour events
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