- Integra LifeSciences (Braintree, MA)
- …programs to enhance the skills and competencies of employees in a medical device -regulated environment. The Senior Training Specialist will assess training ... field with 5+ years' experience in QA/Compliance within the medical device or similar industry or equivalent...of learning management software. + Experience in GMP and quality systems regulations ( FDA QSRs, ISO 13485:2016,… more
- 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
- Abbott (Burlington, MA)
- …types of product complaints. Independently assesses the complaint to determine if a medical device report needs to be filed with various global regulatory ... information on product complaints to various teams (eg Regulatory, Quality Engineering). The other role of the Post Market...work experience **Preferred Qualifications** + 3+ years in MDR ( Medical Device Reporting) + Knowledge of the… more
- Integra LifeSciences (Braintree, MA)
- …(Biomedical or Mechanical) or related discipline with 5+ years of experience in Quality Assurance role for medical device or pharmaceutical manufacturing, ... challenging what's possible and making headway to help improve outcomes. The Senior Quality Engineer I - Design & Reliability Assurance (DRA) is responsible for the… more
- Insight Global (Bedford, MA)
- …- Regulatory submissions, complaint systems, and reporting to authorities. - Solid knowledge of medical device regulations (eg, FDA QSR, EU MDR) and ... that design control and risk management activities for software and digital medical products (SaMD, SiMD) meet all required procedures, standards, and regulations.… more
- Integra LifeSciences (Braintree, MA)
- …(Biomedical or Mechanical) or related discipline, with 3+ years of experience in Quality Assurance role for medical device or pharmaceutical manufacturing, ... are challenging what's possible and making headway to help improve outcomes. The Quality Design and Reliability Assurance (DRA) Engineer II is responsible for the… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …and Skills: **Qualifications** + Bachelor's degree and 15+ years of experience in a FDA regulated pharmaceutical and/or medical device industry environment + ... an experienced and dynamic Executive Director of R&D Global Quality to join our team. This pivotal role will...Previous experience of working in the global pharmaceutical and medical device industry. + Experience working with… more
- AbbVie (Waltham, MA)
- …medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's ... LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Responsible for quality of assigned products which may include small molecule pharmaceuticals… more
- Integra LifeSciences (Boston, MA)
- …experience is required. + A minimum of 2-4 years' experience in a medical device , pharmaceuticals, Quality /Regulatory Compliance, or other cGMP regulated ... product preferred environment. + Familiarity with application of FDA and/or ISO quality standards in a...to, flammable and corrosive liquids, compressed gases, sharps, and medical wastes. Integra LifeSciences is an equal opportunity employer,… more
- Hologic (Marlborough, MA)
- …**Experience** + 7+ years of quality engineering experience in the medical device industry, with a focus on electromechanical and IVD devices. ... Quality Management Systems (QMS), including ISO 13485 and FDA QMSR regulations. + Expertise in root cause analysis,... devices. + Advanced knowledge of electromechanical and IVD medical device standards and best practices. **Skills**… more