- Fresenius Medical Center (Lexington, MA)
- …documentation for EU Notified Body submissions; * Working with ISO13485 and FDA Quality Management System requirements (QSR); * Participating in Internal and ... External audits; * Working cross-functionally with labeling and technical teams and reviewing advertising and promotional materials; and * Reviewing and approving Engineering Change Orders and maintaining UDI records. This is a telecommuting position working… more
- J&J Family of Companies (Danvers, MA)
- …Working knowledge of Microsoft Office Word and Excel + Knowledge in ISO and GMP. US FDA 21 CFR QSR and ISO 13485 a plus Johnson & Johnson is an Equal Opportunity ... Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by… more
- Hologic (Marlborough, MA)
- …Bachelor's Degree or 10+ years with a Master's Degree. + Expertise in FDA Quality System Regulations, especially Design Control requirements, ISO 13485, and Medical ... Device Directive. + Familiarity with ISO 14970, IEC 60601, IEC 62366, and EN 62304. + Experience with managing multi-source demands for project and product support, fostering an effective team environment. + Experience with Oracle or Agile is beneficial. +… more
- North Coast Seafoods (Chatham, MA)
- …the following motions: bending, twisting, squatting and reaching + Exposure to FDA approved cleaning chemicals + Exposure to temperatures: <32 degrees Fahrenheit + ... Ability to work in wet and dry conditions + Ability to work Monday-Friday, weekends when needed + Ability to use tools and equipment, including knives North Coast Seafoods is an equal opportunity employer and does not discriminate against otherwise qualified… more
- CGI Technologies and Solutions, Inc. (Burlington, MA)
- …Quality Management Systems (QMS), ensuring compliance with pharmaceutical regulatory requirements ( FDA , EMA, etc.). * Oversee the implementation and validation of ... systems using Veeva or Trackwise for QMS processes. * Ensure compliance with GxP and 21 CFR Part 11 regulations, and lead validation efforts using tools such as HP ALM to maintain validation traceability and documentation. * Develop and execute validation… more
- J&J Family of Companies (Raynham, MA)
- …the implementation and management of calibration activities to ensure compliance to applicable FDA regulations (ie 21 CFR Part 820.72) guidance documents and ISO as ... required. + This role provides leadership and direction for a team of calibration technicians, tooling specialists at the Raynham, MA. site. The position is responsible for ensuring the team performs within budget using best practices, innovation, and people… more
- Children's Hospital Boston (Boston, MA)
- …compliance for inspection by regulatory bodies overseeing hospital enterprise wide transfusion ( FDA , AABB and the JC). Minimum Qualifications: + Bachelor's degree in ... Nursing OR Physician Assistant OR Clinical Laboratory Science, Medical Technology required + Master's degree preferred Experience: + 5 years working experience in healthcare, nursing, blood management, transfusion medicine, medical laboratory science, or PA… more
- Medtronic (Boston, MA)
- …overnight or occasional flight travel. + Understands and adheres to FDA Regulations, quality and training requirements, SOPs, and Work Instructions-continually ... looking for opportunities to improve quality. + Stay current on internal training requirements and product knowledge. + Proactively propose ideas for process improvement and takes action to drive completion. + Meet deadlines and drive results; proactively… more
- Medtronic (Boston, MA)
- …ability. **Nice to Have** + Experience with Medical Product verification and FDA guidance. + Basic understanding of creating test protocols for verifying software ... requirements. + Participated manual test or automated test script development and execution. + Had5+ years experience testing medical devices controlled by software, especially robotics system. + Ability to manage, track and upgrade multiple hardware and… more
- Bristol Myers Squibb (Devens, MA)
- …Authority requirements. **Knowledge and Skills:** + Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing. + Must ... have the ability to work assigned shift (Day, Night, Weekends and/or Holidays). + Must be able to work in a cleanroom environment and perform aseptic processing + Must be comfortable being exposed to human blood components. + Must be able to be in close… more