- Medtronic (Mounds View, MN)
- …a dynamic and synergistic opportunity for growth. The **Senior** **Clinical Quality ** **Specialist** is responsible for assuring that clinical personnel across ... be accomplished through bringing the clinical organizations into a quality systems model of operation that will bring improved...to Have:** + Knowledge of ISO 13485 and 14155; FDA 21CFR Parts 11, 50, 54, 56, 812,814, 820;Declaration… more
- Medtronic (Brooklyn Center, MN)
- … quality standards and regulatory requirements - Understanding of ISO standards, FDA regulations, or other relevant industry quality standards. + Technical ... assays on samples, and/or finished products from manufacturing, to ensure quality standards and compliance to manufacturing instructions and regulatory requirements.… more
- Medtronic (Minneapolis, MN)
- …technology. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers ... solutions to complex US promotional issues. + Interact directly with FDA and/or indirectly with international regulatory agencies on most projects/products at… more
- Good Sense Foods (New Hope, MN)
- …ensure the facility is cleaned and sanitized according to food safety and quality standards. This role leads the sanitation team, monitors work, ensures compliance ... with regulatory guidelines ( FDA , USDA, SQF, etc.), and works closely with production and quality assurance teams to maintain a safe, clean, and efficient… more
- Medtronic (Fridley, MN)
- …with regulatory requirements for US and Canada imports (eg, Customs, FDA , Health Canada, and Participating Government Agencies). Collaborates with 3rd party ... and share audit findings to maintain or improve service level, service quality and compliance efficiencies. Support and maintain workable dashboards to demonstrate… more
- Biomat USA, Inc. (Moorhead, MN)
- …all state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedure Manual, Occupational Safety and Health Administration ... standards in accordance with Federal and State regulations, with FDA approved Standard Operating Procedure Manual, OSHA, CLIA and...is performed. * Under the guidance of the Center Manager and/or the Assistant Manager , assure facility… more
- Medtronic (Fridley, MN)
- …inputs (customer needs, business needs, etc.) and transform them into high quality engineering requirements. + Perform system architecture and design for all phases ... + Experience working with and designing systems to meet ISO and Quality System Regulation requirements, including IEC-60601-1, -2, -6, IEC-62304, ISO-14971, FDA… more
- Danaher Corporation (Chaska, MN)
- …oral and written reports; update documentation promptly. + Ensure compliance with FDA Quality System Regulations (QSR), Good Manufacturing Practices (GMP), and ... will be a part of the Technical Operations Team and report to the Manager of Manufacturing Science responsible for support ing daily production needs and process… more
- Medtronic (Fridley, MN)
- …ensuring systems meet both technical specifications and regulatory standards (eg, FDA , 21 CFR Part 11). You'll work closely with cross-functional engineering, ... quality , and manufacturing teams to standardize equipment control systems,...Experience with Inductive Automation Ignition (Perspective). + Experience in FDA -regulated industries such as medical device or pharmaceutical manufacturing.… more
- Medtronic (Minneapolis, MN)
- …additional overnight or occasional flight travel. + Understands and adheres to FDA Regulations, quality and training requirements, SOPs, and Work ... Instructions-continually looking for opportunities to improve quality . + Stay current on internal training requirements and...such as Clinical Specialist, Sales Rep, Field Inventory Analyst Manager , District Service Manager or District Sales… more