Siter-Neubauer & Associates is currently conducting a search for Quality Systems Compliance Manager:

QUALITY SYSTEMS COMPLIANCE MANAGER with an INNOVATING MEDICAL DEVICE COMPANY

Responsible for ensuring the company’s quality system compliance to current global quality system regulations and standards for active implant medical device manufacturing. This person will ensure compliance through management of internal and external audit, quality system validation activities, Corrective and Preventive Action system and other compliance activities. This person reports to the Head of Quality Systems and will support the Management Review process.

• Demonstrated certified lead auditor training and experience pursuant to 21CFR820, ISO13485, CMDR, AIMD, South Korea GMP and JPAL regulations.
• Strong knowledge of medical device relevant regulatory requirements, and demonstrate a willingness to keep abreast of regulatory changes.
• Demonstrated knowledge and understanding of the Quality System Regulations (QSR), ISO 14385 requirements and other related medical device regulations.
• Proficiency with Microsoft Word, Excel, and Access.
• Sound reasoning skills and ability to problem solve.
• Lead and work effectively in teams.
• Excellent problem solving skills, using industry accepted concepts and tools to solve complex problems in creative and effective ways as they apply to compliance issues.
• Excellent written and communication skills are a requirement for this position.

• 5+ years’ experience in regulated medical device environment.
• Demonstrated experience in quality systems compliance auditing.
• CAPA and Control of Nonconformance Management Systems, Record Retention and Control.
• Experience in a management or supervisory position, preferable in Quality or Regulatory fields.
• B.S. in Engineering Service, Business Administration, or equivalent experience.
• Certification as Certified Quality Auditor or equivalent formal training and experience in auditing required