- Teleflex (Chelmsford, MA)
- …Verify self and all employees are following GMPs and are auditable at all times. Assures compliance with GMP (ISO 13485, FDA 21 CFR 820, MDD 93/42EEC, and all ... medical technologies, Teleflex is driven by our purpose to improve the health and quality of people's lives. Through our vision to become the most trusted partner in… more
- J&J Family of Companies (Raynham, MA)
- …formulating business plans and budgets to develop and implement products; analyzing quality /safety test results to ensure compliance with internal and external ... be responsible for the implementation and management of calibration activities to ensure compliance to applicable FDA regulations (ie 21 CFR Part 820.72)… more
- Olympus Corporation of the Americas (Westborough, MA)
- …working knowledge of, and experience in applying / developing products in compliance with FDA and international requirements, including 820-CFR, ISO-13485, ... all phases of complex med-device development, as well as ensures compliance to applicable Design Controls, Product Security, and Cybersecurity policies. (IEC62304,… more
- Olympus Corporation of the Americas (Westborough, MA)
- …working knowledge of, and experience in applying / developing, products in compliance with FDA and international requirements, including 820-CFR, ISO14971, ... leadership in all phases of device development, as well as ensure compliance to applicable Design Controls, Product Security, and Cybersecurity policies. Areas of… more
- Whitsons Culinary Group (Berkley, MA)
- …span of control are performed with attention to the highest standards of food quality , safe processes, compliance with all appropriate legal requirements and a ... FUNCTIONS, RESPONSIBILITIES AND DUTIES: + Overall responsibility for all quality and food safety related items at the plant...between WCG and regulatory agencies, such as the USDA, FDA and local Health Departments. Any third-party auditing entity… more
- Medtronic (Boston, MA)
- …interfaces, systems architectures, and protocols, + All activities must be performed in compliance with the Quality System + Performs duties in compliance ... In this exciting and fast-paced role as a Principal Quality Engineer, you will have responsibility for applying and...experience in medical device product development + Familiarity with FDA and ISO standards + Leadership experience at the… more
- Takeda Pharmaceuticals (Boston, MA)
- …in compliance with global regulations (eg, GxP, 21 CFR Part 11, ICH, EMA, FDA , PMDA) and Takeda's quality and risk management standards. + Work closely with ... Technologies (safety databases, signal detection, case processing automation, E2B compliance ). + Ensure platforms are integrated, compliant, and user-centric...architecture, engineering, quality , and data teams to ensure scalable and interoperable… more
- Charles River Laboratories (Boston, MA)
- …patient care. At Boston Children's, their commitment to diversity drives the exceptional quality of care provided to patients from local communities to over 160 ... that the health and welfare of laboratory animals are maintained in compliance with local, state, federal and institutional guidelines and regulations. Responsible… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …day might include:** + Planning and driving all CSV activities required to maintain quality compliance as per existing Policies and Procedures for RCM. + ... IT, Automation, Quality Assurance and End Users to ensure system compliance as well as with outside contractors/vendors to complete validation tasks + Managing… more
- BioLife Plasma Services (Boston, MA)
- …in operational production, including financial, regulatory, administrative, marketing, quality , facilities, and people management. Gain exposure to real-world ... challenges such as audit processes, compliance requirements, and team performance management. + **Production Environment & Customer Service:** Contribute to donor… more
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