Senior QA & Compliance Leader – MedTech (Onsite)

KARL STORZ SE & Co. KG; Auburn (MA); On-site; USD 180,000 - 210,000; Full time

Benefits offered by this job

Medical, dental, vision

Vacation time

Parental leave

Retirement plan

Wellness program

Job summary

KARL STORZ SE & Co. KG in Auburn, MA is seeking a Senior Manager of Quality Assurance to lead the quality program at the site. The role focuses on ownership of the QMS, CAPA, audits, and driving improvements to ensure patient safety and regulatory compliance.

You will partner with global teams and senior leadership to shape quality strategy and outcomes. The position requires extensive medical device quality experience, leadership capability, and strong analytical skills, with onsite work five

Qualifications

• 10+ years of quality experience in medical devices.
• 7+ years of quality auditing experience.
• 3+ years of people leadership experience.
• 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 management

Quality auditing

People leadership

Regulatory knowledge

Stakeholder management

Communication

Job description

KARL STORZ SE & Co. KG in Auburn, MA is seeking a Senior Manager of Quality Assurance to lead the quality program at the site. The role focuses on ownership of the QMS, CAPA, audits, and driving improvements to ensure patient safety and regulatory compliance.

You will partner with global teams and senior leadership to shape quality strategy and outcomes. The position requires extensive medical device quality experience, leadership capability, and strong analytical skills, with onsite work five