- Bayer (Indianola, PA)
- …US FDA; + Strong background in user-centric design, design controls (CFR 820.30, ISO 13485), risk management ( ISO 14971), EU MDR, and requirements engineering; ... + Patient/user advocacy with a solution-oriented mindset; + Excellent lateral leadership and communication skills in English; + Ability to thrive in a dynamic global matrix environment, embracing change and decision-making. This posting will be available for… more
- Saint-Gobain (Claremont, NC)
- …+ Good verbal and written communication skills (Required) + General understanding of ISO methodology ( ISO 9001, 14001, & OHSAS 18001) (Required) + Ability ... to analyze information and evaluate results to choose the best solution (Required) + Demonstrate through actions and behaviors the SG Principles of Conduct and Action (Required) + Familiarity with Lean Manufacturing, TPM, 5S & Six Sigma (Preferred)… more
- Medtronic (Los Angeles, CA)
- …+ Ensure compliance with all regulatory standards, including FDA QSR and ISO 13485. **Required Knowledge:** + Requires a Baccalaureate degree in Electrical ... defense, or automotive. + Familiarity with regulatory standards (FDA QSR, ISO 13485). + Demonstrated experience generating technical documentation such as… more
- Perdue Farms, Inc. (Accomac, VA)
- …+ Maintain team compliance with all relevant regulations, including OSHA, ISO standards, and industry-specific requirements. + Lead corrective actions for ... In depth knowledge of quality control processes and compliance standards (eg, ISO , OSHA). + Excellent problem-solving, organizational and time management skills. +… more
- MyFlorida (Tallahassee, FL)
- …manager to ensure quality assurance and ultimately, improvement, as required under ISO 17025. Works to make inventories (equipment and chemical/reagent) current and ... comply with strict procedural and quality control/quality assurance guidelines in an ISO 17025 accredited laboratory. + Ability to perform calculations. + Ability to… more
- Crowley (Jacksonville, FL)
- …* Compliance & QMS Oversight * Maintain and improve compliance with ISO 9001 and customer-specific requirements, support audit readiness and documentation control. * ... within a fast-paced, high-growth organization. Preferred Qualifications: * Working knowledge of ISO 9001, QMS audits, and regulatory compliance; UL, CSA, or IPC… more
- Abbott (Lake Forest, IL)
- …applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc Identify risk areas within your group and develop strategies ... Certified Auditor etc. + Understanding in the following: US 21 CFR 820 (QSR), ISO 13485, etc. Identify risk areas within your group and develop strategies to… more
- Hologic (Marlborough, MA)
- …+ Deep working knowledge of FDA Quality System Regulations (especially Design Control), ISO 13485, EU Medical Device Regulation, ISO 14971, Risk Management, GMP, ... and GDP. + Proven ability to lead teams and own critical tasks to ensure timely and effective resolution. + Expertise in reviewing and assessing product/project documentation for compliance, and communicating findings to stakeholders. + Advanced proficiency… more
- Google (GU)
- …(especially submarine cables), and familiarity with security frameworks (eg, ISO 27001/NIST), cybersecurity threats, and security certifications (eg, CISSP/CISM). + ... threats. + Lead security investigations and incident response, supporting the ISO 27001 ISMS development and track program performance for continuous improvement.… more
- Erie Industrial Products (Oberlin, OH)
- …usability, and performance, and that they adhere to the quality management system, ISO standards, and customer specifications. This role includes, but is not limited ... and supplier audits. * Additional tasks assigned. Qualifications * Understanding ISO requirements and audits. * Excellent communication skills and interpersonal… more