Quality Manager

ADMEDES INC. LIVERMORE, CA

ADMEDES is the leading global provider of finished Nitinol self-expandable components such as stents and heart valve frames to the medical device industry. We apply the latest micro-machining and surface finishing techniques for rapid response prototypes, pilot line and full-scale manufacturing. Together with products manufactured from tubing, using advanced laser technology, we have also developed a comprehensive range of NiTi braiding and wire forming technologies. ADMEDES Inc. in Livermore, CA is a subsidiary of ADMEDES GmbH in Germany.

ARE YOU A VISIONARY QUALITY MANAGER WITH A PASSION FOR DRIVING EXCELLENCE IN THE MEDICAL DEVICE INDUSTRY?

Join our dynamic team and lead the charge in shaping our quality systems, ensuring compliance, and fostering continuous improvement as we expand our global reach.

RESPONSIBILITIES

• Guide, maintain and improve current Quality system and procedures in alignment with ADMEDES GmbH.
• Develop, plan, and implement department goals and objectives.
• Provide communication, work direction, coaching, training, and guidance for employees.
• Provide quality engineering support and services including internal auditing, qualification, validation, problem analysis, failure investigation, and corrective action.
• Work directly with customers and suppliers to investigate and resolve quality related issues.

REQUIREMENTS

• Bachelor’s degree in Engineering or Natural Sciences with 10+ years of experience in relevant roles within the medical device industry or Master’s degree with 5+ years of experience in relevant roles in the medical device industry.
• Minimum of 2 years in a team leadership or management role.
• Proven experience with ISO 13485, ISO 9001, and 21 CFR Part 820 quality standards.
• Solid understanding of analytical and statistical tools, including basic applications such as Minitab.
• Demonstrated success managing audits conducted by notified bodies, regulatory authorities, customers, and suppliers.
• Strong problem-solving capabilities and ability to work independently in a dynamic environment.
• Fluent English (business level, written and spoken) is required.
• German language skills are an asset and considered a plus.

ANNUAL SALARY

• $ 115,000 - 145,333