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Sr Quality Engineer - Exempt
Job Description
Join our dynamic team in Brooklyn Park, MN, and be part of an innovative company that is a leader in the medical device industry. We are seeking a seasoned professional to ensure the highest quality standards in our products and processes.
Must Have Qualifications
- Previous experience with Quality Systems & CAPA, Change Control, and Validations
- Knowledgeable on Medical Device Regulatory Requirements
- Experience with Quality & Regulatory Audit activities
- 1-3 years of Medical Device industry experience
- Familiarity with FDA 21 CFR Part 820, EU 217/745 (EU MDR)
- Knowledge of ISO 13485, ISO 14971, IEC 60601 standards
- Proficiency in Microsoft Office Applications (Word, Excel, Access, PowerPoint) and Windows OS
- Strong written and verbal communication skills
- Ability to work cooperatively as part of a cross-functional team
- Develop, modify, apply, and maintain quality standards and protocols for processing materials
- Collaborate with engineering and manufacturing functions to ensure quality standards are in place
- Devise and implement methods and procedures for inspecting, testing, and evaluating product precision and accuracy
- Design or specify inspection and testing mechanisms and equipment
- Conduct quality assurance tests and perform statistical analysis
- Ensure corrective measures meet acceptable reliability standards and documentation compliance
- Provide in-depth analysis and recommendations on process improvements
- Validation, Technical Writing, Problem Solving
- Experience with Validation Gap Assessment, Change order creation and documentation update, Revalidation/remediation activities
- Fusion Hollow Fiber Oxygenator (HFO)
- Cardiotomy Venous Reservoirs (CVR)
- Target years of experience: 5-15
- Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
Onsite work is most desired in Brooklyn Park, MN. However, hybrid work arrangements can be discussed for strong candidates.
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Staffing Leader of the Year Anju Abel
CEO, LanceSoft
LanceSoft is proud to announce that its Chief Executive Officer, Anju Abel, has been honored with the prestigious "Staffing Leader of the Year" award at the 2025 TIARA Staffing Awards US. The award recognizes her visionary leadership and significant contributions to improving staffing processes, employee engagement, and workforce outcomes.
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