Senior Quality Manager — Medical Devices & Compliance

Martech Medical Products, Inc.; Harleysville (PA); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

401(k) Retirement Plan

Job summary

Martech Medical Products seeks a Quality Manager to lead Quality Engineering and Quality Control, guiding the QMS to meet FDA and ISO standards and drive continuous improvement. You will influence manufacturing excellence, regulatory compliance, and operational performance across the site.

The role requires 8+ years in quality with leadership experience, strong regulatory knowledge, and a passion for building high-performing teams in a regulated manufacturing setting.

Qualifications

• Bachelor’s degree in Engineering, Quality, Manufacturing, Life Sciences, or a related technical discipline.
• 8+ years in Quality Assurance/Engineering/Systems within regulated manufacturing (medical devices).
• 3+ years in leadership managing quality or technical teams.
• Strong knowledge of FDA QMSR/21 CFR Part 820 and ISO 13485.
• Experience leading CAPA, audits, nonconformance programs, risk mgmt, and CI.
• Analytical, problem-solving, communication, and leadership skills.

Responsibilities

• Lead Quality Engineering and Quality Control to meet quality, compliance, and ops goals.
• Maintain and improve QMS per FDA QMSR, ISO 13485, and regulatory requirements.
• Drive CAPA, audits, nonconformance, investigations, and change control.
• Lead risk management and promote risk-based decision making.
• Collaborate with Manufacturing and Engineering on validations and qualifications.
• Monitor quality metrics and drive continuous improvement initiatives.
• Support cleanroom operations and audit readiness.
• Lead root cause investigations and corrective/preventive actions.
• Represent quality in customer, certification body, and regulatory audits.
• Develop and mentor a high-performing quality team.

Skills

Quality Leadership

Regulatory Knowledge

QMS & ISO 13485

FDA QMSR (21 CFR Part 820)

CAPA & Audits

Risk Management

Data-driven Decision Making

Leadership

Process Validation

Education

Bachelor's degree in Engineering, Quality, Manufacturing, Life Sciences, or related

ASQ CQE or CQA certification

Tools

Minitab

JMP

Job description

Martech Medical Products seeks a Quality Manager to lead Quality Engineering and Quality Control, guiding the QMS to meet FDA and ISO standards and drive continuous improvement. You will influence manufacturing excellence, regulatory compliance, and operational performance across the site.

The role requires 8+ years in quality with leadership experience, strong regulatory knowledge, and a passion for building high-performing teams in a regulated manufacturing setting.