- 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 ... and working remotely. **PURPOSE AND SCOPE** Act as a Quality Business Partner for Software as a Medical Device...as 21CFR 820.30, IEC62304:2016 amd.1, IEC81001-5-1, as well as FDA and MDCG guidance. . Responsible for the planning… more
- Integra LifeSciences (Braintree, MA)
- …2025. + Adequate knowledge of learning management software. + Experience in GMP and quality systems regulations ( FDA QSRs, ISO 13485:2016, CFR 820). + Proven ... what's possible and making headway to help improve outcomes. The Senior Quality Compliance Specialist -Training will create and conduct training programs to enhance… more
- Abbott (Westford, MA)
- …+ Manufacturing experience with companies engaged in the manufacture of high quality , FDA regulated products. + Proven leadership skills, results oriented, ... meet new product introduction schedules all while enhancing product quality and meeting all compliance requirements. **MAIN RESPONSIBILITIES** + Develop,… more
- Teleflex (Mansfield, MA)
- …reliability. 2. Assists in ensuring the manufacturing processes comply with regulatory and quality system standards, including FDA , ISO 13485, and other relevant ... Quality Assurance Engineer 1 **Date:** Aug 22, 2025...driven by our purpose to improve the health and quality of people's lives. Through our vision to become… more
- Philips (Cambridge, MA)
- …right fit if:** + You have a minimum of 3+ years' experience of Quality Engineering experience within FDA regulated, medical device product environments, with a ... The Quality Engineer-Products and Systems is a key member...a key member of our Sleep & Respiratory Care, Quality organization, accountable for ensuring our Sleep & Respiratory… more
- Eliassen Group (Boston, MA)
- …develop corrective actions + Ensure all written materials align with company, quality , and FDA guidelines across all manufacturing components **Experience ... Requirements:** + Ability to manage competing priorities + Overall understanding of process instructions + Life Science Experience + Software Skills Required: MS Platform Suite, Oracle, Coupa + Functional knowledge of Engineering/Maintenance + Maximo or Asset… more
- Catalent Pharma Solutions (Chelsea, MA)
- …Assist with protocol and implement validation procedures in accordance with Quality System Regulations (QSR), FDA and international guidelines; Analyze ... records; Assist with protocol and implement validation procedures in accordance with Quality System Regulations (QSR), FDA and international guidelines; and… more
- Integra LifeSciences (Boston, MA)
- …or other cGMP regulated product preferred environment. + Familiarity with application of FDA and/or ISO quality standards in a government regulated industry. ... new standards of care. **ESSENTIAL DUTIES AND RESPONSIBILITIES:** The Quality Control Technician II will be responsible for performing...(CAPAs). + Assist in preparing for and participating in FDA audits, customer audits, etc. + All other duties… more
- Fresenius Medical Center (Lexington, MA)
- …documentation for EU Notified Body submissions; * Working with ISO13485 and FDA Quality Management System requirements (QSR); * Participating in Internal ... for NxStage Medical, Inc. products. Will provide regulatory input into key quality system processes such as Design Reviews and Engineering Change Orders. Specific… more
- Hologic (Marlborough, MA)
- …a Bachelor's Degree or 10+ years with a Master's Degree. + Expertise in FDA Quality System Regulations, especially Design Control requirements, ISO 13485, and ... with a passion for ensuring the highest standards of quality in medical device design and development? We are...mentoring, and coaching to maximize engagement and productivity. + ** Quality and Compliance** : + Promote awareness and efficacy… more