Senior Quality Systems EngineerBiomerics • Brooklyn Park, MN, US
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Senior Quality Systems Engineer
Biomerics • Brooklyn Park, MN, US
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job_description.job_card.job_descriptionBachelor's Degree or technical degree in an applicable field or equivalent industry experience. Minimum five years experience in a Medical Device manufacturing / product development environment. Working knowledge of FDA QSRs, ISO 13485, and ISO 14971 requirements. Experience with Nonconforming Material, Corrective and Preventive Actions, Direct and Indirect Labor Training, and Quality Management System software. Experience with product / process verifications / validations. Experience developing and supporting Quality Systems as they relate to standards. Must possess good project management skills and initiative in taking on and completing projects. Must possess advanced verbal and written communication skills. Must be able to manage and prioritize multiple projects / objectives. Direct oversight of the Nonconforming Material and Corrective and Preventive Action system. Direct oversight of the Direct and Indirect Labor Training program. Ownership of the document control quality management system. Initiate and drive improvements to systems supported by this role. Act as primary Subject Matter Expert on systems supported by this role. Participate as backup Internal Auditor as time permits. Work with cross-functional teams to develop or improve quality systems related to standards and current business needs. Participate in Manufacturing Engineering / Operations teams to ensure customer product and quality requirements are documented and addressed. Interface with customers on labeling design, development, and packaging considerations. Collaborate with Supplier Quality to ensure all new suppliers are qualified and that new components and materials are adequately qualified. Work with Manufacturing Engineering, Operations, and QC Inspection in the development and qualification of processes. Assist with developing inspection processes and equipment when required. Work with R&D, Manufacturing Engineering, Operations, and Quality during concept, prototyping, and transfer of new products into production. Other assignments as requested. Medical / Dental / Vision Insurance Short-Term Disability Long-Term Disability Life Insurance Paid Vacation Days Paid Holidays 401(k) On-Site Fitness Facility
Company Overview
Biomerics is a world-class manufacturer and innovative polymer solutions provider for the medical device and biotech industries. As a vertically integrated company, we specialize in designing, developing, and producing medical devices for diagnostic and interventional procedures. We are focused on next-generation solutions for vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets. We value integrity, partnership, empowerment, accountability, trust, agility, teamwork, and excellence, and we care about building strategic, mutually beneficial partnerships with customers and team members.
Job Description
- Provide Quality Systems, Engineering, and Compliance support for the Biomerics Quality Management System.
Qualifications
Responsibilities
Benefits
J-18808-Ljbffr
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