- Celestica (Maple Grove, MN)
- … Systems). * Minimum 5 years conducting quality audits. * Experience with FDA and regulatory inspections. * In-depth knowledge of quality management ... organization, collaborating with customers, suppliers, and partners, and ensuring compliance with regulatory requirements ( FDA , ISO, ASQ, RAC). The position is… more
- Medtronic (Mounds View, MN)
- …throughout the product lifecycle. + Ensure compliance with all relevant regulatory requirements, including FDA , ISO, and other international standards, ... degree in Engineering, or a related technical field. Advanced degree preferred. + ** Regulatory Knowledge:** In-depth knowledge of FDA regulations, ISO 13485, ISO… more
- Abbott (Minnetonka, MN)
- …test methods, and NCMR dispositioning. + Knowledge of Quality Systems, FDA regulations, ISO 13485 and applicable worldwide regulatory requirements. + ... requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures,… more
- Philips (Plymouth, MN)
- …right fit if:** + You have a minimum of 10+ years' experience in Design Quality Engineering /Risk management for FDA regulated Medical Device (21 CFR 820, ISO ... effectively. + You have a minimum of a Bachelor's Degree (Required) in Engineering, Quality , Regulatory or comparable disciplines. + You must be able to… more
- Balchem (Faribault, MN)
- …manufactured across multiple sites are safe, compliant with Balchem, customer, and regulatory standards, and meet quality expectations. This role drives a ... Regional Quality Assurance Manager - Minnesota Department: Corp Op...across sites. Knowledge & Experience: + Operated in an FDA regulated environment, ideally food or dietary supplement +… more
- Abbott (Minnetonka, MN)
- … requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... Minimum 2-5 years Engineering experience and demonstrated use of Quality tools/methodologies. + Detailed knowledge of FDA ,...of Quality tools/methodologies. + Detailed knowledge of FDA , GMP, ISO 13485, and ISO 14971 Solid communication… more
- Medtronic (Mounds View, MN)
- … and reliability efforts for Cardiac Ablation Solutions products, ensuring compliance with regulatory standards such as FDA CFR, MDR, IEC 62304, and ISO ... + Advanced degree in a relevant field. + Certification in quality systems or regulatory affairs (eg, Six Sigma, ASQ, or similar). **\#LI-MDT** **Physical Job… more
- Integer Holdings Corporation (Brooklyn Park, MN)
- …measurement tools under guided supervision. This position will work to maintain elements of Quality Management Systems (QMS) in accordance with ISO 13485 and FDA ... and Responsibilities + Adheres to Integer values and all safety and quality requirements including, but not limited to: Quality Management Systems… more
- Aerotek (Rochester, MN)
- …CAPAs, and OOS Phase II investigations, make key decisions on product quality , compliance, and regulatory conformance, and escalate significant risks to ... of quality control and inspection processes. + Familiarity with FDA regulations. **Additional Skills & Qualifications** + Experience in overseeing quality… more
- Otsuka America Pharmaceutical Inc. (St. Paul, MN)
- …planning of regulatory interactions and Provides tables and listings for FDA meeting briefing packages. + Support statistical needs for market access and ... statistical expertise/input in the drug development including clinical development plan and regulatory submission strategy. This is a strategic and critical role in… more