Quality Manager

Reports To: Chief Executive Officer (HSWoA CEO), with dotted-line reporting to Corporate Quality Director

Location: Dudley, MA

FLSA Status: Exempt

Compensation Range: $110,000 - $130,000 annual base salary

Incentive Compensation: Eligible for variable income incentive based on company and individual performance

The Quality Manager provides strategic and hands-on leadership for the Quality function at Henke Sass Wolf of America (HSWoA), ensuring that products, processes, and the Quality Management System (QMS) consistently meet customer, regulatory, and corporate requirements.

As a member of the site leadership team, the Quality Manager leads quality operations and personnel, maintains audit readiness, drives continuous improvement, and partners cross-functionally to strengthen compliance, product quality, and customer satisfaction.

• 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.

• Lead the overall management of Quality operations and Quality personnel required to support customer and HSW Germany requirements.
• Ensure appropriate controls for incoming materials, in-process activities, and outgoing goods to support product quality and compliance.
• Manage and communicate customer complaints, nonconformance reports, and related quality issues, ensuring appropriate investigation and follow-up.
• Anticipate future Quality resource, process, and capability needs in support of customer requirements and HSWoA strategic plans.
• Work closely with Production, Engineering, Supply Chain, and other functions to resolve quality issues and prevent recurrence.
• Develop and maintain meaningful daily, weekly, and monthly Quality reporting and KPIs.
• Access and analyze ERP/SAP and other operational data to identify trends, risks, and opportunities for improvement.
• Lead structured problem-solving and implement effective countermeasures for recurring or systemic quality issues.
• Support continuous improvement and Lean principles while ensuring changes remain compliant with applicable quality and regulatory requirements.

• Lead, coach, and develop Quality team members; establish clear expectations, accountability, and priorities.
• Communicate and coordinate training on Quality, FDA GMP, and related requirements for manufacturing and support teams.
• Promote a culture of quality ownership, urgency, transparency, and cross-functional collaboration.
• Act with integrity and sound judgment while balancing regulatory requirements, customer needs, and business priorities.

• Audit readiness and audit findings / closure effectiveness
• Customer complaint and nonconformance trends
• Corrective action timeliness and effectiveness
• Incoming and outgoing quality performance
• Training and QMS compliance
• Quality-related customer satisfaction and responsiveness
• Continuous-improvement and recurring-defect reduction

• 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.
• Ability to manage multiple priorities and work effectively across functions and with corporate stakeholders.

On-site leadership presence is required in a regulated medical-device production and service environment. The role…