- Actalent (Newton, MA)
- …Key Responsibilities: + Quality Management: Develop, implement, and maintain quality management systems (QMS) in compliance with FDA regulations, ISO ... problem-solving, and decision-making skills. Excellent communication and leadership abilities. + Software : Proficiency in quality management software and… more
- Integra LifeSciences (Boston, MA)
- …Adequate knowledge of learning management software . + Experience in GMP and quality systems regulations ( FDA QSRs, ISO 13485:2016, CFR 820). + Proven ... to advance patient outcomes and set new standards of care. The Senior Quality Compliance Specialist -Training will create and conduct training programs to enhance… more
- Medtronic (Billerica, MA)
- …the biomedical/medical device industry. Navigates various government and industry regulations to include FDA Quality System Regulation 21 CRF 820 and ISO 9001, ... (5) post-Master's experience in each of the following: Biomedical or medical device industry; FDA Quality System Regulation 21 CRF 820, ISO 9001, and ISO 13485;… more
- Curia (Hopkinton, MA)
- Manager, Quality Control in Hopkinton, MA Build your future at Curia, where our work has the power to save lives. Curia is a global contract development and ... + Learning platform + And more! Summary The Manager, Quality Control is responsible for the oversight of the...team resources + Expert in cGMP, USP, EP and FDA regulations + Technical competence including the understanding of… 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. ... outcomes and set new standards of care. **SUMMARY** 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
- Sanofi Group (Framingham, MA)
- **Job Title:** Head of Quality Compliance **Location** : Framingham, MA **About the Job** We deliver 4.3 billion healthcare solutions to people every year, thanks to ... from infectious diseases and bring hope to patients and their families. The Quality Assurance Department is responsible for providing oversight on all GMP activities… more
- Integra LifeSciences (Boston, MA)
- …Sciences. + Minimum 7-years of experience in supplier quality management, quality , manufacturing, or engineering. + Experience in FDA controlled environment. ... of care. This position is for a Sr. Supplier Quality Engineer l - Global Supplier Quality ...ensure compliance with all appropriate regulations and standards, including FDA , ISO 13485, CMDR, MDR, JPAL and 21 CFR… more
- Integra LifeSciences (Boston, MA)
- …pathways to advance patient outcomes and set new standards of care. 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
- Integra LifeSciences (Boston, MA)
- …pathways to advance patient outcomes and set new standards of care. The Quality Design and Reliability Assurance (DRA) Engineer II is responsible for the efficient ... time (where applicable). * Support implementation of SPC programs with Manufacturing and Quality Control as a part of Process Validation and Design Transfer. *… more
- Sanofi Group (Cambridge, MA)
- …quality strategy in various therapeutic areas and markets. Accountable for the Software Quality Engineering, Risk Management and Supplier Control support of ... sooner than ever before. Our team has released an FDA certified class II medical device titration application. We... Engineering Lead. You will be responsible for the quality assurance efforts for our Software as… more