Keller Executive Search ยท 3 months ago
Medical Device Quality Engineering Professional #1508
Gallaway, Tennessee, United States
Full-time
Onsite
Mid, Senior LevelKeller Executive Search is representing a well-established producer of plastic medical devices seeking a Quality Engineering Professional to enhance their quality operations within an FDA-regulated production setting. The role involves managing CAPA processes, supervising quality assurance staff, and maintaining compliance with regulatory standards for medical devices.
Staffing & Recruiting
Responsibilities
Manage CAPA (Corrective and Preventive Action) processes, including investigating customer complaints, performing root cause analysis, and verifying effectiveness of corrective measures
Supervise and guide Quality Assurance Auditors and Analysts in their daily quality assurance responsibilities
Support ongoing improvement programs throughout production operations
Facilitate the creation and upkeep of a robust Quality Management System (QMS) aligned with ISO 13485:2016 standards and FDA 21 CFR Part 820 (QSR) for Class I and II medical devices
Act as the quality point of contact with vendors and customers regarding quality issues
Conduct training sessions for cross-functional teams covering regulatory requirements, quality science, and statistical techniques
Monitor sterilization validation and regulatory adherence for medical device products sterilized by contract facilities
Direct and participate in external and internal quality audits, maintaining preparedness for regulatory inspections from FDA, Health Canada, and additional regulatory bodies
Maintain compliance with applicable regulatory requirements including AAMI sterilization standards, FDA, Health Canada, EPA, OSHA, and others
Deliver quality engineering assistance to manufacturing operations, including developing product specifications, ongoing evaluation, and analyzing data to verify products fulfill their intended purpose
Qualification
Required
Manage CAPA (Corrective and Preventive Action) processes, including investigating customer complaints, performing root cause analysis, and verifying effectiveness of corrective measures
Supervise and guide Quality Assurance Auditors and Analysts in their daily quality assurance responsibilities
Support ongoing improvement programs throughout production operations
Facilitate the creation and upkeep of a robust Quality Management System (QMS) aligned with ISO 13485:2016 standards and FDA 21 CFR Part 820 (QSR) for Class I and II medical devices
Act as the quality point of contact with vendors and customers regarding quality issues
Conduct training sessions for cross-functional teams covering regulatory requirements, quality science, and statistical techniques
Monitor sterilization validation and regulatory adherence for medical device products sterilized by contract facilities
Direct and participate in external and internal quality audits, maintaining preparedness for regulatory inspections from FDA, Health Canada, and additional regulatory bodies
Maintain compliance with applicable regulatory requirements including AAMI sterilization standards, FDA, Health Canada, EPA, OSHA, and others
Deliver quality engineering assistance to manufacturing operations, including developing product specifications, ongoing evaluation, and analyzing data to verify products fulfill their intended purpose
Company
Keller Executive Search
Keller Executive Search is a boutique executive recruitment and advisory firm dedicated to connecting top-tier talent with leading organizations worldwide.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase