- Olympus Corporation of the Americas (Center Valley, PA)
- …Regulatory Compliance . The focus will be over the implementation of the Global Quality Systems Processes, compliance with FDA CFR, Part 820, Quality ... Compliance is responsible for executing a global compliance audit program of the quality management...leads audit activities with all global regulatory agencies (eg FDA , Notified Bodies, PMDA, NMPA etc.) + Creates and… more
- Six Flags Great America & Hurricane Harbor Careers (Gurnee, IL)
- …practiced Assist with food preparation by complying with Food and Drug Administration ( FDA ) regulations Utilize thermometers to complete food quality check and ... compliance with company guidelines Conduct daily safety and quality assurance inspections in compliance with local...daily safety and quality assurance inspections in compliance with local health department and company guidelines Work… more
- Integra LifeSciences (Princeton, NJ)
- …advance patient outcomes and set new standards of care. **SUMMARY** The Senior Quality Compliance Manager will lead, coordinate and perform corporate audits of ... facility engineering and design, statistical analysis, process validation, regulatory compliance , clinical trials, computer systems validation, quality systems… more
- Integra LifeSciences (Braintree, MA)
- …set new standards of care. **SUMMARY DESCRIPTION** The Associate Manager, Quality Compliance supports the development, maintenance, and continuous improvement ... this role has no direct reports, it provides day-to-day guidance to site Quality Compliance personnel and partners closely with cross-functional teams to ensure… more
- Teleflex (Pleasanton, CA)
- …products successfully reaching the marketplace. - Responsible for performing all duties in compliance with FDA 's Quality System Regulation (QSR), ISO13485, ... driven by our purpose to improve the health and quality of people's lives. Through our vision to become...13485, ISO 62304, ISO 14971, IEC 82304-1, MDD, and FDA QSR. - Experience developing mechatronic products with IEC… more
- Integra LifeSciences (Princeton, NJ)
- …pathways to advance patient outcomes and set new standards of care. The ** Quality Compliance Manager, ECMP Site Facilitator** , provides tactical support and ... may have responsibility for more than one site. The ** Quality Compliance Manager, ECMP Site Facilitator** will...+ Experience in implementing remediation programs, and working with compliance frameworks such as FDA , ISO 13485,… more
- Caris Life Sciences (Phoenix, AZ)
- …delivery of FUE CQV activities across the asset and process lifecycle. Regulatory and Compliance Oversight: + Ensure adherence to FDA , GMP, ISO, OSHA, CAP, CLIA ... and FUE compliance efforts are fully aligned with the Caris Quality Management System (QMS), including required protocols and documentation controls. + Provide… more
- Endo International (Greenville, IL)
- …directs the operation of the Greenville Quality Department to ensure product quality and regulatory compliance . The Quality Manager will champion the ... Quality System by evaluating, analyzing, and reporting on product and process quality performance and GMP compliance . S/he will exercise full autonomy for… more
- The Clorox Company (Wheeling, IL)
- …performance metrics and lead continuous improvement initiatives to enhance product quality , food safety, and regulatory compliance . + Partner cross-functionally ... When you join us, you become part of a legacy of bold innovation, quality ingredients, and a passion for making everyday meals extraordinary. We foster a culture… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …products. Supported by more than 40 manufacturing facilities, we provide high- quality medicines, trusted by healthcare professionals and patients, to more than ... a focus on dermatology, ophthalmology and onco-dermatology. **Job Summary:** The Quality Assurance Specialist is responsible for the batch certification review of… more
- Teleflex (Chelmsford, MA)
- …Chelmsford Facility leads the development and execution of strategies to ensure compliance with quality and regulatory standards, while delivering products, ... Ensures the site's Quality Management System (QMS) remains compliant with global quality and regulatory standards, including FDA 21 CFR Part 820, ISO 13485,… more
- Olympus Corporation of the Americas (Westborough, MA)
- …applying Agile development practices for continuous rapid product delivery while maintaining compliance and quality . + Provide project management oversight for ... . **Job Description** This role provides professional expertise for Software quality and best practices in SW design, development, release, and support… more
- BeOne Medicines (San Carlos, CA)
- **General Description:** The Director, Global R&D Compliance will serve as the strategic compliance business partner and advisor to BeOne's Global Research & ... of integrity, providing proactive guidance on current and emerging compliance risks in a rapidly evolving healthcare environment. Acting...& Cosmetic Act (FDCA) + HIPAA and HITECH + FDA and OHRP regulations governing clinical research (eg, GCP)… more
- Integra LifeSciences (West Valley City, UT)
- …I** is responsible for performing in-process and final inspections to ensure compliance with established quality standards and regulatory requirements. This role ... supports the development, implementation, and monitoring of quality programs to ensure that medical devices are manufactured...ensure that medical devices are manufactured and distributed in compliance with ISO 13485, FDA regulations (21… more
- Caris Life Sciences (Irving, TX)
- … Quality Leadership, engineering, and other cross-functional partners to ensure quality in software products through compliance with internal design, ... deep technical expertise, solid experience in risk management and compliance , and a passion for quality and...and SaMD products are in accordance with internal SOPs, Quality System Requirements which include ISO 13485, FDA… more
- Caris Life Sciences (Phoenix, AZ)
- …with internal stakeholders across laboratory, operational, and customer-facing functions to maintain compliance with FDA , ISO 13485, CAP, and CLIA standards ... Quality Event records in alignment with Caris' Quality System procedures and applicable external requirements ( FDA...as a Subject Matter Expert (SME) for CAPA and Quality Event processes, ensuring compliance , consistency, and… more
- Endo International (Raleigh, NC)
- …all raw materials, in-process, finished goods, and stability samples. She/he manages the Quality Control group and compliance activities to achieve key site and ... 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability,… more
- Endo International (St. Louis, MO)
- …Elemental Impurities, and Validation, to support the Generics Business The Sr. Director, Quality is responsible for ensuring cGMP compliance and product ... key partner to site leadership by providing guidance on quality and compliance across the organization. **Job...and audits of manufacturing sites in the area of Quality Systems, and Training. + Interfaces with FDA… more
- Curia (Albuquerque, NM)
- …Manager leads a team that is responsible for ensuring the highest standards of quality and compliance in the manufacturing of parenteral sterile drug products. ... status + Act as the subject matter expert for quality system compliance with procedural and regulatory...Participate in on-site customer and regulatory agency inspections (eg, FDA , EMA, PMDA, CFDA), presenting quality systems… more
- Curia (Springfield, MO)
- …+ 401k program + And more! Essential job duties + Manage the Quality Control Team Performance of analytical testing for various samples and incoming, in ... with the Company and governmental standards of safety and quality , and that all experimental documentation is complete and...Chemical Hygiene Plan. Follow safety rules fully + Maintain compliance with regulations at all levels as well as… more
