- Actalent (Vicksburg, MI)
- …with industry-specific standards, including IATF and ISO 9001, and medical device quality and regulatory requirements. + Actively participate in ... years of experience in a Quality Engineering role within the automotive and medical device industry. + Proficient in engineering drawing review and GD&T. +… more
- Integra LifeSciences (Boston, MA)
- …work experience is required. + A minimum of 2-4 years' experience in a medical device , pharmaceuticals, Quality / Regulatory Compliance, or other cGMP ... outcomes and set new standards of care. **ESSENTIAL DUTIES AND RESPONSIBILITIES:** The Quality Control Technician II will be responsible for performing quality … more
- Medtronic (Milwaukee, WI)
- …cost control, waste reduction and inventory control; NC & CAPA Investigations; Medical Device Quality & Regulatory Compliance (FDA 21 CFR Part 820, ISO ... and five (5) years of experience as manufacturing or quality engineer. Or, Master's degree in Mechanical, Industrial, Biomedical,...years' experience with each of the following: Manufacturing in medical device industry including Class I, Class… more
- Philips (Cambridge, MA)
- …fit if:** + You've acquired 5+ years of experience in the medical device regulatory affairs and/or quality assurance field. Experience authoring SaMD or ... **Senior Regulatory Affairs Specialist (Ultrasound)** The Senior Regulatory...Tech Files required. + Your skills include knowledge of quality system requirements and FDA and/or International product approval… more
- Integra LifeSciences (Braintree, MA)
- …or related field preferred. + 5+ years GMP/GLP laboratory experience in a medical device , pharmaceuticals, Quality / Regulatory Compliance, or other ... Technician** will be responsible for supporting all activities in the Quality Control Microbiology team. This role also involves supporting non-conformance… more
- Catalent Pharma Solutions (Harmans, MD)
- …+ 10+ years of relevant experience in pharmaceutical or medical device manufacturing, quality or regulatory , general business management, technical ... development, analytical research and development, project scale-up, product manufacturing, quality , validations, and regulatory + Experienced contract negotiator… more
- Bausch Health (Bothell, WA)
- … required + Must have a solid understanding of Change Management/Life Cycle Management of medical device products along with the impact of changes on US Canada ... written and communication skills. + Should have experience authoring complete 510(k) submissions, Medical Device license applications (Class II or above), EU MDR… more
- Integra LifeSciences (Braintree, MA)
- …a relevant scientific discipline. + A minimum of 2-4 years' experience in a medical device , pharmaceuticals, Quality / Regulatory Compliance, or other cGMP ... Technician II** will be responsible for performing environmental monitoring, quality control microbiological laboratory testing of in-process, finished goods,… more
- Jabil (West Chester, PA)
- …communities around the globe. Are you experienced in Medical Device Regulatory Compliance? Jabil is seeking a qualified Quality Systems & Compliance Lead ... , you will manage, as an individual contributor, all Regulatory Compliance activities at the assigned sites. You will...exempt personnel + Knowledge of the US and international medical device quality system regulations,… more
- Integra LifeSciences (Plainsboro, NJ)
- …treatment pathways to advance patient outcomes and set new standards of care. The **Sr.** ** Quality Engineer - Medical Device / Pharma** will provide Plant ... Device Directive, the Canadian Medical Device Regulations (CMDR), and other applicable regulatory ...Experience: 6 to 8 years of experience in a Quality Assurance role for medical device… more