- Hologic (Newark, DE)
- …+ Working knowledge of FDA Quality System Regulations, ISO 13485, EU Medical Device Regulation, ISO 14971, Risk Management, GMP, and GDP. + Strong ... Post Market Quality Engineer Newark, DE, United States Marlborough, MA,... and ensuring the safety and effectiveness of life-changing medical devices? Join Hologic's Breast and Skeletal Health Division… more
- Owens & Minor (Morgantown, WV)
- …of statistics, Minitab and/or other statistical software experience * Experience in a medical device manufacturing environment preferred * Medical Device ... our teammates. Owens & Minor teammate benefits include: + Medical , dental, and vision insurance, available on first working...skills, education and location. Summary The purpose of the Quality Engineer role is to provide tactical support with… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …**Minimum work experience:** 8+ years of progressive experience in auditing pharmaceutical or medical device systems, including 2 years of internal and external ... + Strong understanding of pharmaceuticals, with a combination product or medical device manufacturing, packaging and testing processes, and management… more
- Lilly (Indianapolis, IN)
- …for people around the world. **Sr. Principal Infrastructure Architect - Manufacturing & Quality Systems** At Lilly, we unite caring with discovery to make life ... strategic technology leadership across Indianapolis Parenteral Manufacturing (IPM), Indianapolis Device Assembly & Packaging (IDAP), and Indianapolis Device … more
- J&J Family of Companies (Danvers, MA)
- …Interventional Cardiology to be located in Danvers, MA. The MSO role is to provide medical safety stewardship for Medical Device (MD) products. Although a ... with J&J Heart Recovery/Abiomed Impella Pumps. + Background in risk evaluation, medical device /pharma industry, and clinical research. + Knowledge of… more
- Actalent (Maple Grove, MN)
- …processes, and understands GMP requirements for the manufacture of a sterile medical device . Responsibilities + Execute lab-based process development runs in ... Job Title: Senior Quality TechnicianJob Description We are seeking a Manufacturing...bovine pericardium. Additional Skills & Qualifications + Knowledge of medical device design assurance, design control, risk… more
- Stryker (Irvine, CA)
- …engineering or related discipline. + 4+ years' related experience required. + Medical device industry experience required. + Familiarity with New Product ... Sigma Green or Black belts are preferred. + Experience with the medical device development lifecycle, including risk management and design/process verification… more
- West Pharmaceutical Services (DE)
- …of quality related experience with preferred experience in pharmaceutical and/or medical device industry + Experience working with suppliers and supplier ... Senior Specialist, Supplier Quality Requisition ID: 71354 Date: Nov 22, 2025...preferred + Knowledge of cGMP, cGDP, relevant ISO standards, medical device requirements and other international regulations… more
- Medtronic (Lafayette, CO)
- …- Provides expertise in interpreting and implementing regulatory requirements, including medical device directives, FDA regulations, and international standards; ... world. **A Day in the Life** As a Sr. Quality Systems Manager, where you'll play a pivotal role...tools (FMEA, FTA, PHA, ISO 14971) + Knowledge of medical device regulations: FDA 21 CFR Part… more
- Roche (South San Francisco, CA)
- …several audit types and leading at least one audit type within GCP and/or Medical Device . + Knowledge of drug development processes and GxP/CS regulations + ... industry and/or industry and/or nonclinical/clinical research + Minimum 2 years in GCP/CS/ Device Quality Assurance role (auditing) Key Competencies + Ability to… more