- Hologic (Marlborough, MA)
- …oversee product complaint management, adverse event reporting, and root cause analysis, ensuring compliance with regulatory standards such as FDA , ISO 13485, and ... Sr. Manager Post Market Quality Newark, DE, United States Marlborough, MA, United...**Knowledge** + Strong understanding of Medical Device Regulations, including FDA requirements (21 CFR Part 820, Part 803), ISO… more
- Philips (Cambridge, MA)
- …and proven Program leadership experience, leading cross-functional R&D teams, embedding design quality , and/or enabling compliance during innovation. + You have ... The Senior Program Manager-Design Quality , Products & Systems is responsible for the...You've acquired a minimum of 12+ years' experience withing FDA regulated medical device/systems product development environments ( FDA… more
- Integra LifeSciences (Braintree, MA)
- …challenging what's possible and making headway to help improve outcomes. The Senior Quality Engineer I - Design & Reliability Assurance (DRA) is responsible for the ... a seasoned professional engineer with complete and in-depth conceptual knowledge of quality engineering. They are knowledge of quality engineering best practices… more
- Fresenius Medical Center (Lawrence, MA)
- …Understanding of Agile methodology desired but not required. . Thorough understanding of FDA Quality System regulations in relation to software development and ... as 21CFR 820.30, IEC62304:2016 amd.1, IEC81001-5-1, as well as FDA and MDCG guidance. . Responsible for the planning...and evolves approved project deliverables. . Communicates project and compliance issues to Quality Systems management and… more
- Integra LifeSciences (Braintree, MA)
- …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 ... time (where applicable). + Support implementation of SPC programs with Manufacturing and Quality Control as a part of Process Validation and Design Transfer. +… 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 ... to prepare submissions and partic + Makes key decisions on product quality , compliance and regulatory conformance issues for sterile, biological, liquid,… more
- Integra LifeSciences (Boston, MA)
- …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 Certification (eg, CQE, CQA, Six Sigma)… more
- Takeda Pharmaceuticals (Boston, MA)
- …my knowledge. **Job Description** **About the role:** Associate Director, Clinical Program Quality Investigations is responsible for ensuring the compliance of ... serious breach. This position supports Takeda's mission by maintaining high standards of quality and compliance in clinical trials. **How will you contribute:**… more
- Biomat USA, Inc. (Worcester, MA)
- …understand and assess FDA regulations. Strong integrity and commitment to quality and compliance . Full command of mathematics. Legible handwriting. High ... federal, and company-designated regulations. Implements Standard Operating Procedures (SOPs) for quality control and overall regulatory compliance . . Maintains… more
- Teleflex (Chelmsford, MA)
- …implementation, and maintenance of the quality management system (QMS) in compliance with regulatory requirements (eg, FDA , ISO 13485). *Backup support for ... quality system documents to ensure accuracy, completeness, and compliance . *Participate in internal and external audits, providing support and documentation… more