- Kelly Services (Marlborough, MA)
- …expertise and mentorship, without direct reports. **Preferred Qualifications:** + Experience in medical device or other regulated industries. + Familiarity with ... suppliers. The ideal candidate will also bring expertise in validation processes and FDA Design Controls and serve as a technical mentor within the organization.… more
- ConvaTec (Lexington, MA)
- …as a Medical Device ) and SiMD (Software in a Medical Device ) mobile apps while ensuring high quality of the design and code, robustness of our ... Pioneering trusted medical solutions to improve the lives we touch:...performance, security, and scalability. + Design and develop high quality native Android applications using Kotlin and Java. +… more
- Integra LifeSciences (Braintree, MA)
- …or related field preferred. + 5+ years GMP/GLP laboratory experience in a medical device , pharmaceuticals, Quality /Regulatory Compliance, or other regulated ... industry + Familiarity with application of FDA and/or ISO quality standards in a government regulated industry. + Knowledge of QC terms, tools, and… more
- Capgemini (Burlington, MA)
- …verification strategies, manage a team of engineers, and ensure compliance with medical device regulations. **Your Role** . Lead Verification Strategy: Develop ... systems. . Compliance & Standards: Ensure all verification activities align with relevant medical device regulations such as ISO 13485, IEC 62304, and … more
- Integra LifeSciences (Braintree, MA)
- …relevant scientific discipline. + 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 government regulated industry. Quality … more
- United Therapeutics (Boston, MA)
- …daughter's pulmonary arterial hypertension( **PAH)** . Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... ), livers ( **miroliver(R)** ), and a bioengineered external liver assist device for acute liver failure ( **miroliver** **_ELAP_** **(R)** ), with plans… more
- ConvaTec (Lexington, MA)
- …as a Medical Device ) and SiMD (Software in a Medical Device ) mobile apps while ensuring high quality of the design and code, robustness of our ... orlow-level components + Experience working in a regulatedenvironment such as medical devices ( FDA /MDR), HIPAA, GDPR isstronglydesired. + Experience in… more
- AbbVie (Worcester, 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 ... Analytics and Data Integrity to lead site analytics web and data quality initiatives within our pharmaceutical operation reporting into Digital Systems organization.… more
- Integra LifeSciences (Braintree, MA)
- …environment with a working knowledge preferably in the medical device , diagnostics or pharmaceutical industries. Familiarity with FDA regulations and ... implement process-level efficiencies + Drive continuous improvement + Maintains all ISO/ FDA standard operating procedures, work instructions, and forms. + Maintains… more
- Hologic (Marlborough, MA)
- …States Are you a visionary leader with a passion for ensuring the highest standards of quality in medical device design and development? We are seeking a ... 10+ years with a Master's Degree. + Expertise in FDA Quality System Regulations, especially Design Control...System Regulations, especially Design Control requirements, ISO 13485, and Medical Device Directive. + Familiarity with ISO… more