Keller Executive Search · 3 months ago
Medical Device Quality Engineering Professional #1508
Gallaway, TN, US
Full-time
Onsite
Entry, Mid Level
$90K/yr - $100K/yr
2+ years expKeller Executive Search is representing a well-established producer of plastic medical devices seeking a Quality Engineering Professional. The role involves managing quality operations within an FDA-regulated production setting and ensuring compliance with regulatory standards while enhancing product quality.
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
Working knowledge of FDA 21 CFR Part 820 Quality System Regulation (QSR) - this is critical
Bachelor's degree from an accredited institution in Quality, Mechanical Engineering, or Industrial Engineering
Capability to lift and carry materials up to 50 pounds
Proficiency with database systems and Microsoft Office suite
ISO 13485:2016 Lead Auditor certification
Ability to function in a manufacturing setting (exposure to particulates from plastics processes, fumes, and noise)
2-4 years of experience in quality assurance engineering within a medical device manufacturing setting
Excellent communication abilities with capacity to engage effectively with senior leadership and shop floor staff
Background in blow molding and/or plastic injection molding manufacturing operations
Preferred
Knowledge of statistical methods and analysis of quality data
Experience managing vendor/customer quality relationships
Background overseeing sterilization validation processes
SAP proficiency
Experience performing root cause analysis in complaint investigations
Benefits
Comprehensive health benefits
401(k) retirement plan
Paid leave days
Relocation assistance available
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