Senior QA Leader, Medical Devices – Onsite Auburn

Karl Storz Endoscopy; Auburn (MA); On-site; USD 130,000 - 170,000; Full time

Job summary

KARL STORZ Endoscopy in Auburn, MA is seeking a seasoned Quality leader to own site QMS and regulatory compliance. You will lead Quality Assurance, Engineering, and Support teams, advancing patient safety and business performance.

Ideal candidates bring 10+ years in medical device quality, 7+ years auditing, and 3+ years of leadership, with a Bachelor’s and Lead Auditor cert. This onsite role emphasizes collaboration with senior leaders and global teams.

Qualifications

• 10+ years of quality experience in medical devices.
• 7+ years of quality auditing experience.
• 3+ years of people leadership experience.
• Bachelor's degree and Lead Auditor certification (ISO 9001 or 13485).
• Deep knowledge of FDA 21 CFR 820, ISO 13485, MDR, and risk management.
• Strong communication, analytics, and stakeholder management skills.

Responsibilities

• Lead Quality Assurance, Quality Engineering, and Quality Support teams.
• Own site QMS compliance to FDA, ISO, MDR, CE, and global regulatory standards.
• Oversee CAPA, complaints, audits, management review, and quality metrics.
• Serve as Site Management Representative for audits and inspections.
• Drive continuous improvement through data analytics and quality best practices.
• Develop talent, training programs, and a strong quality culture.

Skills

Quality leadership

Regulatory knowledge

Data analytics

Stakeholder management

Communication

Education

Bachelor's degree

Job description

KARL STORZ Endoscopy in Auburn, MA is seeking a seasoned Quality leader to own site QMS and regulatory compliance. You will lead Quality Assurance, Engineering, and Support teams, advancing patient safety and business performance.

Ideal candidates bring 10+ years in medical device quality, 7+ years auditing, and 3+ years of leadership, with a Bachelor’s and Lead Auditor cert. This onsite role emphasizes collaboration with senior leaders and global teams.