Principal Quality Engineer
Job ID 329605 Date posted 03/29/2024- Rochester, MN
- Full Time
- Quality
Mayo Clinic is top-ranked in more specialties than any other care provider according to U.S. News & World Report. As we work together to put the needs of the patient first, we are also dedicated to our employees, investing in competitive compensation and comprehensive benefit plans – to take care of you and your family, now and in the future. And with continuing education and advancement opportunities at every turn, you can build a long, successful career with Mayo Clinic. You’ll thrive in an environment that supports innovation, is committed to ending racism and supporting diversity, equity and inclusion, and provides the resources you need to succeed.
Responsibilities
Join a team where development engineering intersects with world-class healthcare delivery and research. The Division of Engineering designs and implements innovative solutions for a wide variety of priorities at Mayo Clinic. We are a unique resource for a healthcare institution, and one that helps Mayo Clinic maintain its #1 rating in the country for healthcare delivery.
We are seeking a Principal Quality Engineer with experience in supporting and improving a Quality Management System within an FDA-regulated medical device design, development, and manufacturing environment. It is our goal to design and 3D print patient-matched titanium implants for Mayo Clinic patients.
You will report to the Quality Manager within the Division of Engineering. You will work closely with the Quality Management steering team and cross-functional teams of engineers, programmers, and technicians to close-the-gap between existing Division processes to prepare for FDA registration as a medical device manufacturer.
You will use your knowledge of 21 CFR 820 and ISO 13485 to improve existing processes and develop missing processes. You will use your broad understanding of compliance requirements to define and implement improvements to the total Quality System. You will be comfortable implementing change but will also have attention to detail that allows you to deploy systems, train users, and support both upper management and staff members in the use of the QMS.
Qualifications
BS in Engineering or related field with 10 years of related experience; Or MS in Engineering or related field with 8 years of related experience.
Additional Qualifications
The preferred candidate will have experience in:
- New product development in the medical device field
- Design verification and validation
- Process control and process validation in the medical device field
- Leading internal audits
- Test management methodologies and tools
- Administration and maintenance of quality records
- Practical experience with statistics and quality tools
The preferred candidate will also have the following qualifications:
- Significant practical experience working with, and expert knowledge of, the Quality System Regulation and ISO 13485 Excellent verbal and written communication skills
- Demonstrated capability working in a team environment
- Additionally, ASQ Quality Engineer certification (or similar) is strongly preferred
Exemption Status
Exempt
Compensation Detail
$116,542 - $174,740 / year
Benefits Eligible
Yes
Schedule
Full Time
Hours/Pay Period
80
Schedule Details
Monday - Friday days. This position will be a combination of onsite in Rochester and remote.
Weekend Schedule
N/A
International Assignment
No
Site Description
As an Affirmative Action and Equal Opportunity Employer Mayo Clinic is committed to creating an inclusive environment that values the diversity of its employees and does not discriminate against any employee or candidate. Women, minorities, veterans, people from the LGBTQ communities and people with disabilities are strongly encouraged to apply to join our teams. Reasonable accommodations to access job openings or to apply for a job are available.
Recruiter
Shelly Weir
Join our talent community.
Join our global talent community to receive alerts when new life-changing opportunities become available.
-
About Us
If you want to know what it's really like at Mayo Clinic, just ask. You'll find that our pride–in where we work, and in what we do–is a common trait. You will also find a lot of inspiring stories about lives changed for the better.
-
Nurse Residency Program
The Nurse Residency Program (NRP) is for all nurses with less than 12 months of experience, to be completed within the first year. NRP provides a framework for a successful transtion to a professional nurse by promoting educational and personal advancement.
-
Benefits
As your career evolves, our compensation and benefits packages are designed to change with you — meeting needs now, and anticipating what comes next. We know that when Mayo Clinic takes care of you, you can take better care of our patients.
Equal opportunity
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, protected veteran status, or disability status. Learn more about "EEO is the Law." Mayo Clinic participates in E-Verify and may provide the Social Security Administration and, if necessary, the Department of Homeland Security with information from each new employee's Form I-9 to confirm work authorization.
Reasonable accommodations
Mayo Clinic provides reasonable accommodations to individuals with disabilities to increase opportunities and eliminate barriers to employment. If you need a reasonable accommodation in the application process; to access job postings, to apply for a job, for a job interview, for pre-employment testing, or with the onboarding process, please contact HR Connect at 507-266-0440 or 888-266-0440.
Job offers
Job offers are contingent upon successful completion of a post offer placement assessment including a urine drug screen, immunization review and tuberculin (TB) skin testing, if applicable.
Recruitment Fraud
Learn more about recruitment fraud and job scams
Advertising
Mayo Clinic is a not-for-profit organization and proceeds from Web advertising help support our mission. Mayo Clinic does not endorse any of the third party products and services advertised.
Advertising and sponsorship policy | Advertising and sponsorship opportunities
Reprint permissions
A single copy of these materials may be reprinted for noncommercial personal use only. "Mayo," "Mayo Clinic," "MayoClinic.org," "Mayo Clinic Healthy Living," and the triple-shield Mayo Clinic logo are trademarks of Mayo Foundation for Medical Education and Research.
Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below.
Terms and Conditions | Privacy Policy | Notice of Privacy Practices | Notice of Nondiscrimination
© 1998-2024 Mayo Foundation for Medical Education and Research (MFMER). All rights reserved.