- BD (Becton, Dickinson and Company) (San Diego, CA)
- …+ Ensure compliance with design control processes per FDA 21 CFR Part 820, ISO 13485, and IVDR. + Lead risk management activities ( ISO 14971), including ... Strong knowledge of design control, risk management, and regulatory standards (FDA, ISO , IVDR). + Experience in companion diagnostics, flow cytometry or clinical… more
- Continental Engineering & Manufacturing (Chaska, MN)
- …members to enhance their skills and advance their careers. We are ISO 9001:2015 certified and committed to delivering cost-efficient, reliable products while ... results with both internal teams and external customers, take ownership of ISO 9001:2015 compliance, and drive initiatives that ensure continuous improvement and… more
- McKinstry (Spokane, WA)
- …and quality records. + Maintain compliance with applicable codes, certifications, and standards ( ISO 9001, ASME, UL, ICC-ES, LEED). **What You Need to Succeed at ... and GD&T. + Experience with quality standards and codes: ISO 9001, ASME Section IX, AWS D1.1, UL, and...Auditor certification. + Working knowledge and understanding of the ISO 9001:2015 Standard and its application. + ASQ Certification.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …relevant regulations and standards, including FDA 21 CFR Part 820, 21 CFR Part4, ISO 13485, ISO 14971, and Gilead's quality system requirements. Plan and ... intervals), test method validation (MSA, GageR&R), and risk management principles per ISO 14971, including FMEA and systems analysis. Expertise in one of these… more
- Kelly Services (Jacksonville, FL)
- …will be instrumental in improving equipment performance, ensuring compliance with FDA, ISO , and GMP standards, and supporting the deployment of innovative automation ... **Regulatory Compliance** Ensure all automation systems comply with FDA regulations, ISO standards, and GMP requirements specific to medical device manufacturing. +… more
- Integra LifeSciences (Princeton, NJ)
- …the company. All audits shall be performed in compliance with recognized ISO , GMP, GDP, GCP, and GLP, global policies/procedures and corporate auditing requirements, ... + Intimate knowledge of the 21 CFR Part 820, ISO 13485, EU Medical Device Regulation, and MDSAP country...roll-out and implementation of GMP, GDP, GCP, GLP, and ISO 14971 would be considered an asset. + Participated… more
- LSI Solutions (Victor, NY)
- …make a difference in the medical device industry. By joining LSI SOLUTIONS(R) an ISO 13485 certified company, you will become part of as energetic team working ... Compliance Oversight: Ensure all marketing materials and communications comply with FDA, ISO 13485, EU MDR, and other applicable regulatory standards. + Team… more
- Danfoss (Forest City, NC)
- …and rapid improvement events. + Support Quality Manager: Ensure compliance with ISO 9001 and IATF 16949 standards, maintaining certification and supporting audits. + ... and Process Failure Mode Effects Analysis (PFMEA). + Support ISO 9001 and IATF 16949 certifications, audits, and document...pursuit of an engineering degree). + Proficient knowledge of ISO 9001 and IATF 16949 (training available for new… more
- BRECOflex CO., LLC (Eatontown, NJ)
- …effective communication, and a customer-focused approach. BRECOflex CO., LLC is an ISO 9001 certified company. This role is responsible for learning, understanding ... and demonstrating ISO 9001 standards through daily work activities. What You'll...drive components, serving diverse industries since 1989. As an ISO -certified company, we prioritize innovation, quality and continuous improvement… more
- DEKA Research & Development (Manchester, NH)
- …on-going compliance with applicable SOPs and regulations, such as 21 CFR 820 and ISO 13485. + Use critical thinking to determine the best approach. + Use experience ... and lead in Risk Management activities in accordance with ISO 14971:2019. + The development, implementation, and approval of...standards and regulations such as 21 CFR 820 and ISO 13485:2016 required. + Experience developing and leading quality… more