Compensation :
$108k-$115k per year annual salary. Exact compensation may vary based on several factors, including skills, experience, and education. Benefit packages for this role may include healthcare
insurance offerings and paid leave as provided by applicable law.
Job Description :
In this role, responsibilities include maintaining and supporting medical electrical equipment electrophysiology recording systems and RF therapy capital equipment. Include managing change notices, monitoring post-market product performance, implementing product modifications, and ensuring nonconformance and CAPA compliance. Actively participate in various forums, standards councils, and cross-functional teams to support coordination across different geographic regions. Responsible for maintaining legacy products, supporting post-market reporting (PMVP, PMVR, PMSR), and managing Quality System deviations. Led audit support, NCEP / CAPA processes, and quality tracking across complex, multi-site environments. Applied systematic problem-solving, mentored teams, and drove process improvements aligned with VIP and Continuous Improvement goals. Knowledgeable in End-of-Life processes and regulatory standards. Reviews authors change notices quality records potential audits and participation in lab experiments with R&D and the ability to present technical subjects (design perspectives) to directors and VP's.
Must haves :
Nice to have skills and experiences :
Quality Control Engineer • Arden Hills, MN, United States