Quality Manager

Quality Manager Manufacturing

Position Overview

We are seeking an experienced Quality Manager to lead quality operations within a precision manufacturing environment. This position will oversee day-to-day quality activities, provide leadership to quality personnel, maintain regulatory and customer compliance, and partner with manufacturing and engineering teams to drive continuous improvement.

The ideal candidate brings hands-on manufacturing quality experience along with strong knowledge of ISO 13485, FDA requirements, quality systems, auditing, metrology, and structured problem-solving. Experience supporting medical device or other highly regulated manufacturing environments is strongly preferred.

Key Responsibilities

• Lead and supervise quality personnel, including workload planning, priorities, scheduling, and daily quality activities.
• Ensure manufactured products meet customer specifications, internal quality standards, and applicable regulatory requirements.
• Serve as a primary quality contact for customers regarding product concerns, requests, corrective actions, and new product introductions.
• Coordinate and support customer, regulatory, and quality system audits.
• Manage quality processes including MRB, PPAP, first article inspection, receiving inspection, internal audits, calibration, and Control Plans.
• Support dimensional inspection activities using CMMs, portable measurement systems, vision measurement equipment, and other metrology tools.
• Develop and review Control Plans for prototype and production manufacturing.
• Establish and maintain quality procedures, specifications, inspection methods, and testing requirements for incoming, in-process, and finished products.
• Manage customer returns, non-conformances, complaints, and corrective/preventive actions through closure.
• Analyze internal quality data and customer complaints to identify trends and drive corrective actions.
• Maintain quality records and documentation in accordance with ISO 13485 and applicable FDA requirements.
• Manage CAPA and non-conforming product processes.
• Maintain quality metrics and KPI reporting used for management review.
• Develop and deliver quality-related training for manufacturing and technical personnel.
• Lead and coach structured problem-solving using methods such as 5-Why, Fishbone, Pareto analysis, and 8D.
• Apply process capability, Gage R&R, and statistical methods to evaluate manufacturing and measurement variation.
• Partner with engineering, manufacturing, operations, and other teams on continuous improvement initiatives.
• Maintain a strong presence on the manufacturing floor and provide hands-on quality support as needed.

Qualifications

• Bachelor s degree in Engineering, Quality, or a related technical discipline preferred; equivalent relevant experience may be considered.
• Quality experience within a manufacturing environment required.
• Previous quality leadership or supervisory experience preferred.
• Experience working directly with customers on quality-related matters.
• Experience supporting customer and regulatory audits.
• Strong knowledge of root cause analysis, corrective action, and defect prevention methodologies.
• Experience with ISO 13485 and FDA-regulated quality systems strongly preferred.
• Six Sigma knowledge or experience preferred.
• Experience with CAPA, non-conforming material, PPAP, Control Plans, first article inspection, and internal auditing.
• Familiarity with CMMs and other dimensional inspection/metrology equipment.
• Experience within low-volume, high-mix manufacturing environments preferred.
• Knowledge of fabrication processes such as laser cutting, punch press, progressive die stamping, forming, hardware insertion, welding, and metal finishing is highly desirable.
• Strong leadership, communication, organization, and problem-solving skills.
• Ability to work effectively with customers, production personnel, engineers, and senior leadership.

Schedule

• Primarily first shift with flexibility as operational needs require.

Benefits

• Medical, dental, and vision insurance.
• 401(k) with company match.
• Paid holidays and vacation.
• Opportunities for professional growth and advancement.