- Teleflex (Chelmsford, MA)
- …investigation teams. Understands the fundamentals of root cause investigation, risk management, and medical device Quality Management Systems per 21 CFR 820, ISO ... BS Degree in Engineering (or related technical field) * 2-5 years related ( medical device preferred) experience * Experience with statistical analysis using… more
- Stryker (Tempe, AZ)
- …assess biocompatibility test plans, data, and special process validations for medical device cleaning and reprocessing. + Risk-Based Change Assessment: ... experience, including 4+ years leading technical biocompatibility projects in the medical device industry, with proven expertise in biological evaluation… more
- Abbott (St. Paul, MN)
- …equivalent combination of education and work experience. + 2+ years of related medical device experience + Working technical knowledge and application of ... of their impact on the systems environment. **Preferred Qualifications** + Medical Device experience **Additional Qualifications:** * Be innovative, resourceful,… more
- Zimmer Biomet (Englewood, CO)
- … R&D team. As a Product Development Engineer I, you'll help bring new medical device concepts to life-leading targeted design and development tasks within a ... engineering discipline with 2-4 years of experience. + Prior experience in medical device development helpful. + Experience in taking medical device… more
- Actalent (Watertown, CT)
- …Responsibilities + Ensure that all testing processes and product developments comply with relevant medical device regulations such as FDA (21 CFR Part 820) and ... standards. + Conduct risk assessments to identify potential hazards associated with the medical device and develop mitigation strategies. + Perform Failure Modes… more
- Zimmer Biomet (Norfolk, VA)
- …leader and Management Representative responsible for directing the quality function a medical device design and manufacturing site. Utilizes quality statistics ... QMSR, GMP, ISO and other relevant regulatory requirements as applied to medical device development, manufacturing and distribution. + Demonstrated independent… more
- J&J Family of Companies (Santa Clara, CA)
- …Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated ... quota. . Partner with Clinical, Field Clinical Reps, Marketing, R&D and other business units to identify selling opportunities...the company. . Comply with all corporate compliance, FDA, medical device , quality standards and ethics. .… more
- Medtronic (Northridge, CA)
- …Quality Engineering related to manufacturing Site Quality. Plan, coordinate, and execute Medical Device standards activities to ensure the safety and reliability ... QSR (Quality Systems Regulations), ISO13485, ISO14971, ISO11135, ISO11737, MDD ( Medical Device Directives) 93/42, AIMDD (Active Implantable...to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference… more
- Philips (Murrysville, PA)
- …years' experience in Supplier Quality Engineering within highly regulated product environments ( Medical Device preferred), with a focus on supplier selection, ... SPC, SCAR's, SICR, CAPA, Remediation etc. + You have detailed knowledge of medical device regulations, requirements, and standards, such as 21 CFR Parts… more
- Danaher Corporation (New York, NY)
- …working in a corporate, global or regional marketing role involving diagnostic or medical device products/services. + Exposure to P&L responsibility, and the ... product teams to execute with supporting organizations (sales, commercial marketing, medical affairs, R&D , manufacturing, regulatory, quality, etc.) on the… more