Compliance Engineer IV - Military Veterans
at KARL STORZ Endoscopy-America, Inc.
Are you a detail-oriented engineer passionate about compliance and technology? Join KARL STORZ as a R&D Quality Engineer IV and play a crucial role in shaping the future of medical technology!
What you'll be doing:
- You will oversee global component planning, establish standards, and solve complex vendor-related issues while ensuring compliance with regulatory requirements.
- Collaborate with other Engineering teams to analyze components, reduce costs, and set specifications.
- Manage compliance with regulations like China RoHS and REACH, working closely with QA teams.
- Facilitate end-of-life (EOL) projections and manage component replacements.
- Maintain the global parts library and provide training on compliance standards.
- Participate in product development teams to manage Design History Files and ensure adherence to FDA/QSR and ISO regulations.
- Conduct internal audits and respond to corrective actions promptly.
What you'll need to be considered:
- Bachelor's degree in Mechanical, Electrical, or Software Engineering preferred.
- Minimum of 10 years in component engineering, with 8+ years in a medical device environment.
- Experience with reusable medical devices and familiarity with FDA Quality System Regulation (21 CFR Part 820) and ISO standards (13485, 9001).
- Ability to evaluate electronic component data sheets in circuit designs is a plus.
Who we are:
KARL STORZ is an independent, family-owned supplier of advanced medical technology. For 80 years, we've pioneered the most groundbreaking innovations in endoscopy, surgical imaging, and OR integration to benefit patients and healthcare providers alike.
Every day, we apply cutting-edge technology, precision engineering, and award-winning customer support to help healthcare facilities manage costs, streamline operations, and deliver exceptional patient outcomes. With facilities across the country and countless opportunities in the field, we attract a diverse and talented staff, motivated by the chance to make a lasting positive impact. At KARL STORZ, it's not just about the tools we create -it's about the lives we change, together.
Apply Today to make an impact in the medical device industry!
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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
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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.
Charlton, 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.