- Teleflex (Chelmsford, MA)
- …such as metric reporting, document control, and audit participation. A strong background in quality assurance within the medical device industry, along with ... document retention policies, Good Documentation Practices and archiving / scanning Device History Records *Analyze and review quality system documents… more
- J&J Family of Companies (Danvers, MA)
- …+ BA/BS or equivalent is required, with 8-10 years of proven experience in medical Device . + Excellent communication skills, able to quickly build credibility ... Compliance Specialist will be a member of the Abiomed and J&J Regulatory Compliance teams, will work with Quality Operations leads of the designated CSS… more
- AbbVie (Waltham, MA)
- …and International plants for further packaging and/or testing. Primary driver for the quality and compliance + Develops Global Product Quality Assurance ... that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a...submissions and partic + Makes key decisions on product quality , compliance and regulatory conformance issues for… more
- Teleflex (Mansfield, MA)
- …* 0-2 years of Quality Assurance experience working in the medical device manufacturing environment (a combination of education and experience will ... Procedures (SOPs) for various quality and manufacturing related processes in a medical device environment, preferred. TRAVEL REQUIRED: 0 - 10 % \#LI-AD1… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …degree and 15+ years of experience in a FDA regulated pharmaceutical and/or medical device industry environment + Strong knowledge of current global Good ... and implementing procedures to ensure that the business units quality management and compliance program are effective...Previous experience of working in the global pharmaceutical and medical device industry. + Experience working with… more
- Philips (Cambridge, MA)
- …of 3+ years' experience of Quality Engineering experience within FDA regulated, medical device product environments, with a focus in Design Quality ... for hardware and Software design and ensure they meet quality and compliance standards for every planned...working knowledge of Risk Management (ISO 14971) and global medical device product regulations, requirements and standards.… more
- Sanofi Group (Cambridge, MA)
- …and Development + Experience in regulated industry + Experience in pharmaceutical, medical device , and/or healthcare compliance training + Background ... **Job Title:** Compliance Policies and Training Project Manager, Ethics and...a wide range of health and wellbeing benefits including high- quality healthcare, prevention and wellness programs and at least… more
- Hologic (Marlborough, MA)
- …+ In-depth understanding of FDA Quality System Regulations, ISO 13485, and Medical Device Directive. + Expertise in compliance issues and regulatory ... on integrity and compliance . **Experience:** + Minimum 12+ years in the medical device industry. + Proven track record in quality system strategy, risk… more
- Integra LifeSciences (Braintree, MA)
- … mindset, a willingness to learn about sterilization and microbiology, an understanding of medical device quality systems, and a commitment to ensuring ... (Biomedical or Mechanical) or related discipline, with 5+ years of experience in Quality Assurance role for medical device or pharmaceutical manufacturing,… more
- Hologic (Marlborough, MA)
- …**Experience** + 7+ years of quality engineering experience in the medical device industry, with a focus on electromechanical and IVD devices. ... Manager, Quality Engineering Marlborough, MA, United States We're looking... devices. + Advanced knowledge of electromechanical and IVD medical device standards and best practices. **Skills**… more