Why Mayo ClinicMayo 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 (https://jobs.mayoclinic.org/benefits/) – 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.ResponsibilitiesJoin 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.QualificationsBS 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 QualificationsThe preferred candidate will have experience in:
significant practical experience working with, and expert knowledge of, the Quality System Regulation and ISO 13485
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
Excellent verbal and written communication skills
Demonstrated capability working in a team environment
ASQ Quality Engineer certification (or similar) is strongly preferred
Exemption StatusExemptCompensation Detail$xx,xxx - $xx,xxx / yearBenefits EligibleYesScheduleFull TimeHours/Pay Period80Schedule DetailsMonday - Friday days. This position will be a combination of onsite in Rochester and remote.Weekend ScheduleN/AInternational AssignmentNoSite DescriptionJust as our reputation has spread beyond our Minnesota roots, so have our locations. Today, our employees are located at our three major campuses in Phoenix/Scottsdale, Arizona, Jacksonville, Florida, Rochester, Minnesota, and at Mayo Clinic Health System campuses throughout Midwestern communities, and at our international locations. Each Mayo Clinic location is a special place where our employees thrive in both their work and personal lives. Learn more about what each unique Mayo Clinic campus has to offer, and where your best fit is. (https://jobs.mayoclinic.org/alllocations)Affirmative Action and Equal Opportunity EmployerAs 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.RecruiterShelly WeirEqual opportunityAs 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.
