Quality Manager - Medical Devices

Martech Medical Products•Harleysville, PA

3d•Onsite

About The Position

At Martech Medical Products, quality is more than compliance. It's a commitment to the patients who depend on the medical devices our customers bring to market. We're looking for an experienced Quality Manager to lead our Quality Engineering and Quality Control teams and help shape the future of our quality organization. This is a high-impact leadership role where you'll influence manufacturing excellence, regulatory compliance, operational performance, and continuous improvement across the facility. If you're passionate about building strong teams, driving process improvements, and creating a culture where quality is everyone's responsibility, we'd love to hear from you. As Quality Manager, you'll serve as a key member of the site leadership team and be responsible for the overall effectiveness of our Quality Management System while ensuring compliance with FDA and international quality standards.

Requirements

Bachelor's degree in Engineering, Quality, Manufacturing, Life Sciences, or a related technical discipline.
8+ years of progressive experience in Quality Assurance, Quality Engineering, or Quality Systems within the medical device industry or another highly regulated manufacturing environment.
3+ years of leadership experience managing quality or technical teams.
Strong knowledge of FDA Quality System Regulations (QMSR/21 CFR Part 820), ISO 13485, and quality system requirements.
Experience leading CAPA, audits, nonconformance programs, risk management activities, and continuous improvement initiatives.
Strong analytical, problem-solving, communication, and leadership skills.

Nice To Haves

ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or similar certification.
Lean Six Sigma Green Belt or Black Belt certification.
Experience with ISO 14971 risk management methodologies.
Experience supporting Class I, II, and/or III medical devices.
Experience with process validation, SPC, MSA, and statistical analysis tools such as Minitab or JMP.
Experience with supplier quality management and audit programs.

Responsibilities

Lead Quality Engineering and Quality Control teams to achieve quality, compliance, and operational objectives.
Maintain and continuously improve the Quality Management System (QMS) in accordance with FDA QMSR (21 CFR Part 820), ISO 13485, ISO 14971, and applicable regulatory requirements.
Drive quality system initiatives, including CAPA, internal audits, nonconformance management, complaint investigations, and change control activities.
Lead risk management efforts and promote risk-based decision making across manufacturing and business processes.
Partner with Manufacturing and Engineering to support process validations, equipment qualifications, automation initiatives, and new product introductions.
Monitor quality metrics and implement continuous improvement initiatives that improve performance, reduce risk, and enhance customer satisfaction.
Support cleanroom manufacturing operations, contamination control programs, and ongoing audit readiness.
Lead root cause investigations and implement effective corrective and preventive actions.
Serve as the primary quality representative during customer, certification body, and regulatory audits.
Develop, coach, and mentor a high-performing quality team while fostering a culture of accountability, collaboration, and continuous improvement.
Collaborate with Operations, Engineering, Supply Chain, and Regulatory Affairs to ensure product quality, regulatory compliance, and operational effectiveness.