12 Sr. Quality Engineer Jobs in Golden Valley, MN
Inspire Medical Systems is Hiring a Sr. Quality Engineer Near Golden Valley, MN
WHY JOIN OUR FAST-GROWING TEAMAt Inspire, we value people – your diverse experiences, backgrounds, and thoughts. We elevate voices and encourage learning opportunities to build a professional network that grows into community. We embrace a people-first culture by offering hybrid work schedules, excellent benefits, 401k matching, ESPP, flexible time off (FTO), and tuition reimbursement.
If you’re passionate about making a difference in people’s lives and want to work with innovative technology, come be a part of our great team!
ABOUT THIS POSITIONWe are recruiting a Sr. Quality Engineer to join Inspire Medical Systems located in Minneapolis, MN. In this role, you will be a member of a small, cross functional team focusing on a strategic initiative. It will be a fast-paced environment where you will contribute to multiple different roles.
OPPORTUNITIES YOU WILL HAVE IN THIS ROLE
- Recommend creative and efficient solutions while maintaining compliance to Inspire procedures and geographic regulations.
- Support and/or lead risk management activities from product concept through commercialization.
- Provide expertise, generate, and/or approve the following: DHF deliverables, Engineering Change Orders (ECOs), Risk Management documents, supplier change request records, and Device Master Record (DMR) deliverables.
- Partner with Inspire manufacturing team to lead/support quality engineering activities with contract manufacturers (e.g., IQ, OQ and PQ support, non-conformance resolution, temporary authorities, and deviations, etc.)
- Collaborate and review clinical study protocols and regulatory submissions
- Ensure design history content integrity, completeness, and regulatory / standards compliance; Collaboratively communicate & resolve gaps with cross-functional team members.
- Provide quality engineering support for design changes and supplier changes.
- Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Complete training requirements and competency confirmations as required for this position within the required timeline.
- Comply with applicable quality system procedures/policies and make suggestions for continuous process improvement.
- Document product and therapy related field reports within the prescribed timelines and provide any necessary documents required to complete the investigation. Provide follow-up reporting as needed.
- Bachelor’s degree in a technical or scientific field, preferable an engineering discipline
- 5 years minimum experience in medical device
- Demonstrated creative and effective problem solving and original thinking for compliance solutions
- Demonstrated team leadership skills and ability to prioritize, execute and report on projects
- Ability to work on multiple tasks concurrently with changing priorities
- Knowledge of ISO and FDA Quality System Requirements (e.g., ISO 13485; ISO 14969; IEC 62304; FDA 21 CFR Part 820)
- 10 years minimum experience in medical device
- Experience with multiple quality system functions (risk management, design assurance, manufacturing, post market surveillance)
- Experience with Class III active implantable products.
- Experience with risk management standard ISO14971 as well as risk management tools such as dFMEA and pFMEA.
Inspire Medical Systems is an equal opportunity employer with recruitment efforts focused on ensuring a diverse workforce. Applicants with a disability that need accommodation to complete the Inspire Medical Systems application process should contact Human Resources at 844-672-4357 or email careers@inspiresleep(dot)com
Inspire Medical Systems participates in E-Verify.
Job Summary
Full Time
Medical Technology
$104k-124k (estimate)
05/24/2024
06/21/2024
inspiresleep.com
MINNEAPOLIS, MN
200 - 500
2007
MARILYN CARLSON NELSON
$50M - $200M
Medical Technology
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The job skills required for Sr. Quality Engineer include Problem Solving, ISO, Leadership, Risk Management, Integrity, etc. Having related job skills and expertise will give you an advantage when applying to be a Sr. Quality Engineer. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Sr. Quality Engineer. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Sr. Quality Engineer positions, which can be used as a reference in future career path planning. As a Sr. Quality Engineer, it can be promoted into senior positions as a Quality Assurance Engineer IV that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Sr. Quality Engineer. You can explore the career advancement for a Sr. Quality Engineer below and select your interested title to get hiring information.
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