Quality Manager – Medical Devices & Regulatory Excellence

Frey Consulting Group; Dudley (MA); On-site; USD 110,000 - 130,000; Full time

Job summary

Henke Sass Wolf of America, Inc. seeks a Quality Manager to lead the Quality function at the Dudley, MA site, ensuring products, processes, and the QMS meet customer, regulatory, and corporate requirements.

You will lead quality operations, maintain audit readiness, drive continuous improvement, and partner across functions to strengthen compliance, product quality, and customer satisfaction. On-site leadership and collaboration with manufacturing, engineering, and supply chain are essential to

Qualifications

• Bachelor's degree in Mechanical Engineering, Industrial Engineering, Quality, or a related technical field, or equivalent relevant experience.
• Minimum three years of experience in a federally regulated industry; medical-device or similarly regulated manufacturing experience strongly preferred.
• Demonstrated direct leadership experience with the ability to coach, develop, and hold team members accountable.
• Working knowledge of FDA Quality System requirements, GMP, and ISO 13485.
• Experience leading or supporting customer, regulatory, or notified body audits.
• Strong analytical, problem-solving, organizational, and communication skills.
• ERP experience required; SAP experience preferred.

Responsibilities

• Maintain and continually improve the HSWoA Quality Management System in compliance with FDA Quality System requirements and ISO 13485.
• Partner with management and functional leaders to interpret and implement applicable regulatory and corporate quality requirements.
• Maintain inspection and audit readiness through effective documentation, training, corrective action, and follow-through.
• Lead customer, notified body, and other external audits of the HSWoA QMS and coordinate timely responses and corrective actions.
• Prepare and coordinate the annual Management Review, including quality KPIs, trends, risks, and countermeasures in partnership with the CEO.

Skills

Leadership

Analytical thinking

Regulatory knowledge

Quality management

Communication

Education

Bachelor's degree in Mechanical/Industrial Engineering or Quality

Tools

SAP

Job description

Henke Sass Wolf of America, Inc. seeks a Quality Manager to lead the Quality function at the Dudley, MA site, ensuring products, processes, and the QMS meet customer, regulatory, and corporate requirements.

You will lead quality operations, maintain audit readiness, drive continuous improvement, and partner across functions to strengthen compliance, product quality, and customer satisfaction. On-site leadership and collaboration with manufacturing, engineering, and supply chain are essential to