We are seeking an experienced Quality Manager to lead our quality assurance and quality control operations. In this role, you will oversee our Quality Management System (QMS), drive regulatory compliance, and lead a dedicated team of 2-3 Quality Engineers. The ideal candidate brings strong expertise in ISO 13485 and

ISO 9001

standards, a hands-on leadership style, and a proven track record of maintaining high product quality standards in a regulated medical device manufacturing environment. Key Responsibilities Team Leadership & Operations Manage, mentor, and develop a team of 2-3 Quality Assurance / Quality Control professionals. Oversee day-to-day QA/QC operations, including incoming inspection, in-process testing, and final product release. Establish key performance indicators (KPIs) for product quality, manufacturing consistency, and supplier management. Quality System & Compliance Maintain, audit, and continually improve the company's Quality Management System (QMS) to ensure full compliance with

ISO 13485 , ISO 9001

, and

FDA 21 CFR

Part 820 regulations. Serve as the primary point of contact for external regulatory audits, ISO registrar audits, and customer quality reviews. Manage the internal audit program, including audit scheduling, execution, report generation, and corrective action follow-ups. CAPA, Risk Management & Continuous Improvement Lead the CAPA (Corrective and Preventive Action) process, ensuring thorough root-cause investigations and effective implementation of corrective measures. Oversee Risk Management activities in accordance with ISO 14971, including Risk Management Plans, FMEAs, and Risk Reports. Partner cross-functionally with Manufacturing, Engineering, and R&D to support Design History Files (DHF), Process Validation (IQ/OQ/PQ), and Change Control procedures.

Qualifications & Requirements Experience:

5+ years of quality engineering/management experience in medical device manufacturing, with at least 2 years in a direct supervisory or management capacity.

Standards Expertise:

In-depth, working knowledge of ISO 13485 and

ISO 9001

(FDA

QSR 21 CFR 820

familiarity preferred).

Education:

Bachelor's degree in Engineering, Life Sciences, Quality Assurance, or a related technical field (or equivalent combination of education and experience).

Skills:

Demonstrated track record of leading root-cause analysis (5-Why, Fishbone) and managing CAPA systems. Experience with internal auditing and hosting external ISO/FDA audits. Strong communication, cross-functional collaboration, and decision-making skills. Preferred Qualifications

ISO 13485

Lead Auditor Certification. CQM/OE or CQE certifications from ASQ (American Society for Quality). Experience with Lean Manufacturing or Six Sigma methodologies (Green/Black Belt).

Compensation & Benefits Base Salary:

$120,000 - $150,000 commensurate with experience

Relocation Support:

Comprehensive relocation assistance package available for out-of-area candidates Full health, dental, and vision insurance options 401(k) retirement plan with company match Paid Time Off (PTO) and paid holidays

Pay:

$120,000.00 - $150,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Paid time off Relocation assistance Tuition reimbursement Vision insurance

Work Location:

In person