Job Description:

Department: Quality

Job Location: Walton, KY

Job Summary:

The Medical Device Quality Manager supports the Quality Management System (QMS) for the medical device business and ensures the Quality department meets quality assurance and regulatory requirements, including 21 CFR Part 820 (Quality Management System Regulation, which incorporates ISO 13485:2016) and other applicable FDA requirements. This role directly supports the Director of Quality, maintains a compliant QMS, and reports compliance issues directly to the Director of Quality. The Quality Manager must have quality experience and is expected to perform all tasks safely while observing the QMS requirements and company quality standards.

Key Responsibilities:

· Develop, maintain, and scale the QMS to ensure continuous compliance with ISO 13485, FDA 21 CFR Part 820, and applicable international regulations.

· Lead internal, customer, and third-party regulatory audits (e.g., FDA, ISO certification bodies), and maintain an ongoing audit-ready state.

· Oversee Corrective and Preventive Action (CAPA) programs, Nonconformance Reports (NCRs), and Material Review Board (MRB) activities.

· Manage customer complaints, product quality investigations, and Medical Device Reporting (MDR) obligations.

· Oversee the supplier quality management program, including vendor evaluations, qualification audits, and incoming material controls.

· Evaluate and authorize manufacturing engineering changes, process validation protocols, risk assessment documents (such as pFMEAs), and final product specification criteria to maintain uncompromising safety and quality.

· Govern the data integrity and validation lifecycle of critical computerized systems—including the eQMS, ERP, and production software—safeguarding strict compliance with FDA 21 CFR Part 11 and EudraLex Annex 11 regulations.

· Mentor, train, and manage quality control and assurance staff while promoting a culture of quality across all departments.

· Partner with R&D and engineering teams to ensure compliance with Design Controls (21 CFR 820.30) from concept through commercialization.

· Establish, track, and report on Quality Objectives and Key Performance Indicators (KPIs) for senior leadership reviews and continuous improvement planning.

· Provide required QMS documentation, technical file components, and quality data to support FDA 510(k), PMA, or CE Mark submissions.

Qualifications, Essential Experience and Skills:

· Bachelor's degree in science, engineering, or a technical field.

· Minimum 3 years' experience in an FDA-regulated environment; medical device manufacturing experience preferred.

· Minimum 3 years' experience working in a Quality department.

· Working knowledge of 21 CFR Part 820 (QMSR), ISO 13485:2016, and ISO 14971 risk management, FDA 21 CFR Part 11 and EudraLex Annex 11 regulations

· Familiarity with Medical Device Reporting (21 CFR Part 803), corrections and removals (21 CFR Part 806), and Unique Device Identification (21 CFR Part 830).

· Ability to perform systems, process, and product audits; ISO 13485 internal or lead auditor training preferred.

· ASQ certifications (for example CQE, CQA, CBA, or CMQ/OE).

· Ability to work efficiently in a fast-paced, high-volume environment.

· Strong attention to detail and strong sense of urgency.

· Well organized, with excellent communication, leadership, and interpersonal skills.

· Ability to maintain confidentiality.

· Strong analytical and effective problem-solving skills.

· Ability to effectively lead by example.

· Computer skills, including Microsoft Office.

· Ability to manage multiple projects and meet deadlines.

Physical Requirements:

· Ability to lift 5-20 pounds infrequently

· Reach and lift overhead

· Crouch and lift from floor level

· Walk, stand or sit up to 95%

· Work in temperatures between 50° F to 85° F

PPE Required:

· Smock/suit, shoe covers, dust mask, eyeglasses

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or

responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at

any time, with or without notice.