- Boar's Head Brand/Frank Brunckhorst Co., LLC (New Castle, IN)
- …Food Safety and Quality programs are being executed as required by both internal quality programs/systems as well as required by FDA and USDA. + Lead the FSQ ... certify New & Existing Local Purveyors (and their teams) in FDA compliance. + Oversee Quality Auditing programs including SQF and/or similar programs. + Provide… more
- Medtronic (North Haven, CT)
- …customers, government regulatory agencies, etc. + Demonstrated knowledge of applicable Quality , FDA (Food & Drug Administration) Medical Device Directives/ ... BE ASSIGNED:** + Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies… more
- Tecomet (Claypool, IN)
- …and other performance metrics. **Principle Responsibilities** + Maintaining applicable quality system, environmental, and FDA requirements/certifications. + ... Manufacturing operations - forging and/or machining. + Measuring devices. + Quality Systems. + Regulations - FDA , GMP and ISO. + Blueprint reading. + GD&T. +… more
- Tecomet (Lansing, MI)
- …and other performance metrics. **Principle Responsibilities** + Maintaining applicable quality system, environmental, and FDA requirements/certifications. + ... Manufacturing operations - forging and/or machining. + Measuring devices. + Quality Systems. + Regulations - FDA , GMP and ISO. + Blueprint reading. + GD&T. +… more
- Caris Life Sciences (Phoenix, AZ)
- …+ Manage CAPA and Quality Event records in alignment with Caris' Quality System procedures and applicable external requirements ( FDA 21 CFR, ISO 13485, ... trends and performance metrics. + Familiarity with US and International Quality System regulations ( FDA 21 CFR 820/903) ISO 13485, CAP, CLIA, IVDR, PMDA, or… more
- Globus Medical, Inc. (Audubon, PA)
- …of 5 years of experience is needed within Medical Device Quality Assurance/ Quality Systems with experience in FDA and CE Notified Body inspections + ... is a plus + Demonstrated knowledge and understanding of the Quality System Regulations ( FDA ) and standards, ISO 13485, and other related regulations with… more
- Hologic (Newark, DE)
- …product development/R&D is beneficial. **Skills & Attributes:** + Working knowledge of FDA Quality System Regulations, ISO 13485, EU Medical Device Regulation, ... Post Market Quality Engineer Newark, DE, United States Marlborough, MA,...FDA inspections and supplier audits. + Support monthly Quality Investigation Review boards. **Qualifications & Experience:** + Bachelor's… more
- Hologic (San Diego, CA)
- …the company's quality system activities and design comply with the FDA 's Quality System Regulations (QSRs), ISO 13485, and applicable state requirements. ... environment, ideally in the IVD space. + Working knowledge of Quality Management System for Medical Device Manufacturing FDA 21 CFR 820, ISO 13485 as well as CE… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …them in a large-scale and rapidly evolving business. + Provide operations and quality leadership during FDA and notified body site inspections. + Interface ... 14971), and ISO/EC (MDD/MDR, IVDD/IVDR, MDSAP, CMDR, ISO 13485, J-PAL) requirements, Quality Assurance/Control, Statistical analysis, and FDA QSR's (21 CFR Part… more
- Hologic (Newark, DE)
- …investigation, and product development/R&D. **Skills:** + Deep working knowledge of FDA Quality System Regulations (especially Design Control), ISO 13485, ... Senior Post Market Quality Engineer Newark, DE, United States Marlborough, MA,...and external audits, including facility, supplier, Notified Body, and FDA inspections. + Own preparation and presentation of materials… more
- Abbott (Alameda, CA)
- …Experience conducting complaint investigations in a regulated environment. + Knowledge of FDA Quality System Regulations (QSR) and ISO 13485 standards. ... 114,000 colleagues serve people in more than 160 countries. ** Quality Systems Analyst II** **Working at Abbott** At Abbott,...not limited to: + Complaints trending and summaries + FDA Medical Device Reporting (MDR) trending and summaries +… more
- Cretex (Bloomington, MN)
- …to detail and organizational skills. + In depth knowledge of 13485, 14971, FDA Quality System Regulation, 21CFR Part 820, Good Manufacturing Practices, or ... of companies. Learn more at www.qtspackaging.com and www.cretexmedical.com. Responsibilities Quality Manager Ideal Candidate Profile QTS is currently seeking an… more
- Hologic (Marlborough, MA)
- …engineering, we encourage you to apply! **Knowledge:** + Strong understanding of FDA Quality System Regulations, including Design Control requirements, ISO ... Senior Product Quality Engineer Marlborough, MA, United States Newark, DE,...PhD in a related field. + Experience in an FDA -regulated industry preferred. + Hands-on experience in root cause… more
- Curia (Springfield, MO)
- …+ Assist in Curia documentation compilation, systems and controls to ensure inspection-ready quality systems (ISO, FDA , QP, EMEA) for domestic and international ... Position overview The Quality Assurance (QA) Specialist III is responsible for...QA experience in pharmaceutical, biotechnology, medical device, and/or cGMP FDA -regulated industry Preferred + Experience working with third-party contract… more
- Cardinal Health (Indianapolis, IN)
- …network across business and functional units to achieve positive outcomes. + Assists Quality Management with FDA and other regulatory agency activities. + ... **_What Quality Assurance contributes to Cardinal Health_** Quality...experience working with 21 CFR 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device) preferred +… more
- Envista Holdings Corporation (Brea, CA)
- …5 years of experience in quality engineering within medical device industry. + FDA Quality System Regulation Part 820 and ISO 13485 experience. + Certified ... **Job Description:** **POSITION SUMMARY** The Sr. Quality Engineer plans and conducts activities concerned with...and process changes. + Maintains a working knowledge of FDA GMP, ISO 13485 standards and other applicable standards.… more
- US Tech Solutions (San Bruno, CA)
- …standards and corporate requirements. **Regulatory Compliance:** 1. Ensure compliance with US FDA Quality System Regulations, ISO 13485, and integration of best ... throughout the software development lifecycle, including familiarity with SDLC processes and Quality Management Systems (QMS) compliant with US FDA regulations… more
- BD (Becton, Dickinson and Company) (El Paso, TX)
- …Quality Engineering, Supplier Quality while maintaining full compliance with FDA Quality System Regulations (21 CFR Part 820), all applicable ... Release, Quality Engineering, Customer Complaint Investigation and Supplier Quality . + Knowledge of FDA regulatory requirements (QSRs - 21 CFR Part 820) +… more
- Abbott (Alameda, CA)
- …Qualifications** + Prior medical device experience + Masters degree + Detailed knowledge of FDA Quality System Regulations (21 CFR Part 820), GMP, and ISO 13485: ... **What You'll Work On** + Lead, mentor and motivate a team of Quality Engineers. + Communicate confidently and effectively with all levels of management, peers,… more
- Fresenius Medical Center (Lawrence, MA)
- …Understanding of Agile methodology desired but not required. . Thorough understanding of FDA Quality System regulations in relation to software development and ... **PURPOSE AND SCOPE** Act as a Quality Business Partner for Software as a Medical...as 21CFR 820.30, IEC62304:2016 amd.1, IEC81001-5-1, as well as FDA and MDCG guidance. . Responsible for the planning… more