- Medtronic (Boston, MA)
- …additional 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...needs. + Proven ability to produce consistent, detail oriented, high- quality work. + Ability to make sound decisions and… more
- Integra LifeSciences (Braintree, MA)
- …/Regulatory Compliance, or other regulated industry + Familiarity with application of FDA and/or ISO quality standards in a government regulated industry. ... Technician** will be responsible for supporting all activities in the Quality Control Microbiology team. This role also involves supporting non-conformance… more
- Hologic (Marlborough, MA)
- …understanding of regulatory standards like ISO-13485, ISO-14971, ISO-9001, CFR 820, and FDA requirements. + Familiarity with Quality Management Systems (QMS) and ... Principal Electrical Supplier Quality Engineer Marlborough, MA, United States Are you...MA, United States Are you passionate about ensuring top-notch quality and compliance in manufacturing? We're looking for a… more
- Integra LifeSciences (Braintree, MA)
- …or other cGMP regulated product preferred environment. + Familiarity with application of FDA and/or ISO quality standards in a government regulated industry. ... Technician II** will be responsible for performing environmental monitoring, quality control microbiological laboratory testing of in-process, finished goods,… more
- Bristol Myers Squibb (Devens, MA)
- …with cross functional teams. + Must have sound knowledge and experience in FDA regulated cGMP warehousing, Quality , and compliance environments. Prefer to also ... Cell Therapy team. The **Manager, Shop Floor QA** is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to… more
- Nanobiosym, Inc. (Cambridge, MA)
- …build test fixtures for hardware validation and functional testing. + Support regulatory and quality processes with a focus on FDA and ISO 13485 compliance. ... designing advanced PCB systems, driving embedded hardware development, and delivering high- quality products to market. This is a hands-on, technical leadership role… more
- Curia (Hopkinton, MA)
- MANAGER, QUALITY ASSURANCE in Hopkinton, MA Build your future at Curia, where our work has the power to save lives Curia is a global contract development and ... to cure and ultimately to improve patients' lives. The Quality Assurance Manager is responsible for oversight of the...of 5 years of relevant work experience in an FDA -regulated pharmaceutical environment with at least 2 years in… more
- Catalent Pharma Solutions (Chelsea, MA)
- … Quality and Compliance standards and requirements, with preferable FDA experience; + Demonstrated knowledge of Change management and Lean principals; ... Director of Quality Catalent, Inc. is a leading global contract...EU and US Regulatory agencies such as MHRA, IBM, FDA , USDA; + Ability to work under pressure to… more
- Boston University (Boston, MA)
- **HUMAN RESEARCH QUALITY MANAGER, School of Medicine, Clinical Research** **Job Description** **HUMAN RESEARCH QUALITY MANAGER, School of Medicine, Clinical ... Type** Full-Time/Regular The Human Research Protection Program (HRPP) Human Research Quality Manager will perform quality assurance monitoring and auditing… more
- Fresenius Medical Center (Waltham, MA)
- …of FDA guidelines, Good Manufacturing Practices (GMP) and relevant quality standards for pharmaceuticals and medical devices + Expertise in reviewing, revising, ... six core values supporting our promise to improve the quality of life of every patient every day. These...related industries + Several years of practical experience in FDA inspections and cooperation with US regulatory authorities (experience… more