Manager, Quality Assurance - Military Veterans
at KARL STORZ Endoscopy-America, Inc.
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 Quality Assurance Manager at KARL STORZ, a global leader in endoscopy, medical device technology, and healthcare solutions.
Why KARL STORZ?
- 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.
What you will be doing:
- Quality System Oversight: Ensure compliance with FDA, ISO, EN, and MDR standards, leading audits, CAPA processes, and driving quality improvement initiatives.
- Data Analytics: Analyze field failure data to identify trends, make recommendations for design or process improvements, and reduce costs and service impact.
- Audits & Compliance: Host and manage internal and external audits, ensuring quality system adherence across global operations.
- Leadership & Mentoring: Lead a team, provide training, and foster a collaborative, high-performance culture. Drive continuous improvement across the quality system.
- Cross-Functional Collaboration: Work closely with departments like engineering, production, and customer service to resolve issues and improve quality and compliance.
What you will need to be considered:
- Experience: 7+ years in quality management roles within the medical device industry; 3-5 years in quality auditing.
- Education: Bachelor's degree in a relevant field.
- Certifications: Lead Auditor training for ISO 9001/ISO 13485, CQE or CQM certifications preferred.
- Skills: Strong knowledge of FDA regulations, ISO standards (13485, 14971), and experience with ERP systems like SAP. Proficiency in Microsoft Office tools.
- Leadership: Proven ability to lead and mentor teams, delivering high-quality results and driving cross-functional collaboration.
What's in it for you?
- Competitive Compensation: Attractive salary and benefits, including healthcare, retirement plan, and more.
- Career Advancement: Access to ongoing training, leadership development, and internal growth opportunities.
- Work-Life Balance: Flexible work environment with minimal travel required (up to 20%).
- Impactful Role: Make a tangible difference in the quality of healthcare products, ensuring they meet the highest standards.
Who we are:
KARL STORZ is an independent, family-owned company headquartered in Germany's renowned MedTech manufacturing region. For 80 years, we've pioneered the most groundbreaking innovations in endoscopic surgery, video imaging, and OR integration to benefit patients and healthcare providers alike.
With a 9000+ employees worldwide, we pride ourselves on harnessing cutting-edge technology, precise workmanship, and unrivaled customer support. In doing so, we help healthcare facilities manage costs, streamline operations, and deliver positive patient outcomes.
Ready to make an impact? Apply today and help us shape the future of medical technology at KARL STORZ.
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MA Applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Eligible Employee Benefits
- Medical / Dental / Vision including a state-of-the-art wellness program and pet insurance, too!
- 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
- We prepay your tuition up to $5,250 per year! - Tuition pre-imbursement
- Fitness reimbursement of up to $200 annually
- And much more!
Credentialing requirements at KARL STORZ
KARL STORZ is committed to maintaining a safe work environment for our employees and customers. Most field-based roles at KARL STORZ require hospital credentialing/health screens as a condition of employment. Credentialing can include required vaccinations, health screens & other requirements as outlined by our customers. During the interview process, we encourage you to ask how credentialing/health screens may impact the role you are seeking and if you require any reasonable accommodations regarding these requirements.
Pay Transparency
The pay range and/or hourly pay rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job posting and may be modified in the future. When determining a specific team member's base salary and/or hourly pay rate, several factors will be considered including such things as location, specialty, service line, years of relevant experience, education, professional credentials, internal equity, and the amount budgeted for the role.
Equal Employment Opportunity & Reasonable Accommodation Statement
KARL STORZ is committed to creating an inclusive space where employees are valued for their skills and unique experiences. To achieve this goal, we are committed to diverse voices, and all applicants will receive consideration without regard to race, color, sex, national origin, disability, veteran status, or any other protected characteristic. KARL STORZ is also committed to providing reasonable accommodations during our recruitment process. Should you need assistance or accommodation please email us at taoperations@karlstorz.com.
Get in Contact
Vaccine requirements at KARL STORZ due to COVID-19
KARL STORZ is committed to maintaining a safe work environment for our employees and therefore we require the COVID-19 vaccine for all of our employees unless otherwise due to an underlying medical condition or sincerely held religious beliefs. During the interview process, we encourage you to ask how COVID-19 may impact the role you are seeking and if you require a reasonable accommodation regarding the vaccine requirement see below on the process for requesting accommodation. Please click here to learn more about our overall response to COVID-19.
Employee Benefits Program Overview for U.S. Locations
- Medical / Dental / Vision including a state of the art wellness program and pet insurance, too!*
- 3 weeks’ vacation, 10 holidays plus paid sick time*
- 401K retirement savings plan providing a match of 60% of the employee’s first 6% contribution
- Section 125 Flexible Spending Accounts
- Life, STD, LTD & LTC Insurance
- Tuition reimbursement of up to $5,250 per year
- Fitness reimbursement up to $200 annually
- Employee referral program of up to $2,000 per hire
*Field sales, internships and part-time employees are not eligible except for where required by state law.
Non-employees, including temporary workers and consultants, are not eligible to participate in KARL STORZ benefits program.
KARL STORZ reserves the right to change or modify the employee’s job description whether orally or in writing, at any time during the employment relationship. Additionally, KARL STORZ, through its supervisors, may require an employee to perform duties outside their normal description within the sole discretion of the supervisor. Employee must comply will all applicable KARL STORZ policies and procedures.
Equal Employment Opportunity & Reasonable Accommodation Statement
KARL STORZ is committed to creating an inclusive space where employees are valued for their skills and unique experiences. To achieve this goal, we are committed to diverse voices and all applicants will receive consideration without regard to race, color, sex, national origin, disability, veteran status or any other protected characteristic. KARL STORZ is also committed to providing reasonable accommodations during our recruitment process. Should you need assistance or accommodation please email us at TaleoAdministrator@karlstorz.com.
Notice to Employment Agencies
This recruitment assignment is being managed directly by KARL STORZ’s Human Resources team. Human Resources will reach out to our preferred, contracted agency partners in the rare instance additional talent options are required. Your respect for this process is appreciated. KARL STORZ does not accept unsolicited Agency resumes. Resumes received which were unsolicited by KARL STORZ Human Resources department will be ineligible for referral fees.
Bellingham, MA
Global company stability. Small company feel.
At KARL STORZ, you’ll have the opportunity to develop a more rewarding career filled with opportunities that you never thought possible.
Where technology meets humanity
KARL STORZ has been a leading provider of advanced endoscopy systems and related medical technology for more than 75 years.
We’re all about long-term, sustainable development—and that goes for both our products and our people. Our family-oriented culture gives you the tools you need to thrive at work and the time you need to recharge at home.
You’ll get to bring your authentic self to work every day and advance your career with a company that shares your goals—another reason why so many people on our team have stayed with us for so long.
Join KARL STORZ and experience a more enriching career, one where the work you do supports our goal to put best-in-class medical technology into the hands of skilled surgeons to save patient lives every day.