About the position
Join Our Team at KARL STORZ U.S. - Elevate Quality and Drive Continuous Improvement. Are you passionate about quality and regulatory compliance in the medical device industry? Do you thrive in a leadership role, guiding teams to achieve excellence? If so, we want you to join our team as a Manager, Quality Assurance at KARL STORZ, a global leader in endoscopy, medical device technology, and healthcare solutions. Be Part of Innovation: Drive continuous improvement and contribute to products that impact healthcare worldwide. Leadership Impact: Lead and develop a talented team, influencing quality initiatives and shaping the future of medical technology. Career Growth: With our commitment to ongoing learning, you'll have ample opportunities to advance and expand your skill set in a dynamic environment.
Responsibilities
- Ensure compliance with FDA, ISO, EN, and MDR standards, leading audits, CAPA processes, and driving quality improvement initiatives.
- Analyze field failure data to identify trends, make recommendations for design or process improvements, and reduce costs and service impact.
- Host and manage internal and external audits, ensuring quality system adherence across global operations.
- Lead a team, provide training, and foster a collaborative, high-performance culture.
- Work closely with departments like engineering, production, and customer service to resolve issues and improve quality and compliance.
Requirements
- 7+ years in quality management roles within the medical device industry.
- 3-5 years in sterilization/clean room and machining operations.
- Bachelor's degree in a relevant field.
- Lead Auditor training for ISO 9001/ISO 13485, CQE or CQM certifications preferred.
- Strong knowledge of FDA regulations, ISO standards (13485, 14971), and experience with ERP systems like SAP.
- Proficiency in Microsoft Office tools.
- Proven ability to lead and mentor teams (2+ years), delivering high-quality results and driving cross-functional collaboration.
Benefits
- Medical / Dental / Vision including a state-of-the-art wellness program and pet insurance.
- 3 weeks vacation, 11 holidays plus paid sick time.
- Up to 8 weeks of 100% paid company parental leave; includes maternal/ paternal leave, adoption, and fostering of a child.
- 401(k) retirement savings plan providing a match of 60% of the employee's first 6% contribution (up to IRS limits).
- Section 125 Flexible Spending Accounts.
- Life, STD, LTD & LTC Insurance.
- Tuition pre-imbursement up to $5,250 per year.
- Fitness reimbursement of up to $200 annually.
