Quality Manager

About the Role

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.

Responsibilities

• Quality Management System & Regulatory Compliance
  • 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.
• Quality Operations & Customer Support
  • 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.
• Performance, Data & Continuous Improvement
  • 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.
• Leadership & Quality Culture
  • 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.

Key Performance Indicators

• 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

Requirements

• 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.

Work Environment

On-site leadership presence is required in a regulated medical-device production and service environment. The role requires regular interaction with manufacturing operations and the ability to walk throughout the facility, including use of stairs. Occasional travel to corporate headquarters, customer, supplier, or other business sites may be required.

Must be able to work additional hours when business needs require. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Training Requirements

• Job training according to the current Training Plan.
• Ongoing training for continual improvement.
• General Safety, GMP, FDA, and OSHA training as required.