- Philips (Mount Pleasant, PA)
- …(PFMEA) and associated controls in relation to design changes and assists in Manufacturing Process Development and Design Transfer activities. * Supervises non ... Continuous Improvement techniques and Leadership + Prefer experience in Medical Device , Process Improvement, Continuous Improvement, Design for Quality, CAPA.… more
- Applied Technical Services, Inc. (Latrobe, PA)
- Mechanical Lab Manager Job Details Job Location PRODUCT EVALUATION SYSTEM - LATROBE, PA Position Type Full Time Description Applied Technical Services, LLC ("ATS" or ... clients across a diverse set of large and stable end markets including manufacturing , power generation, aerospace, medical, and defense. ATS was founded in 1967 and… more
- Jabil (West Chester, PA)
- …the quality aspects of New Product Introduction (NPI) and Product / Process transfer. Familiarity with medical device quality systems a plus. BE AWARE OF ... a trusted partner for the world's top brands, offering comprehensive engineering, manufacturing , and supply chain solutions. With over 50 years of experience across… more
- Globus Medical, Inc. (Audubon, PA)
- …skills in software engineering, and a good understanding of the development process for medical devices together with clinical knowledge of the targeted procedures. ... development team developing procedural software applications. + Create and maintain product and system software architecture. + Define, manage and track development… more
- Globus Medical, Inc. (Audubon, PA)
- …and PMA submissions a plus + Experience assessing regulatory impact of product / process changes + Experience reviewing labeling, promotional literature, etc. + ... while following FDA 21 CFR regulations. **Essential Functions:** + Partners with Product Development and management to prepare and review 510(k) submissions +… more
- Philips (Reedsville, PA)
- …data-driven solutions, and reducing reliance on manual inspection throughout the manufacturing process . + Monitor and analyze key performance indicators ... responsible for implementation and support of the First Time Right and Product Release Optimization program, supporting process improvement and promote… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …mitigation of Quality risks from development through commercial registration and product distribution. **Job Description** + This critical leader will inspire and ... Risks will be reported periodically to Senior Management through the Management Review process to ensure alignment with Company policy and strategy and gain a… more
- PCI Pharma Services (Philadelphia, PA)
- …and regulatory compliance. + Conduct risk assessments (eg, FMEA, pFMEA) and lead process improvement initiatives across the product lifecycle. + Serve as a ... manufacturing , or construction in regulated industries. + Strong understanding of product design, process optimization, and risk mitigation strategies. +… more
- Globus Medical, Inc. (Limerick, PA)
- …to ensure they are adequately deburred + Measures and inspecting medical device products in accordance with manufacturing specifications + Loads/unloads parts ... and/or written instructions such as part drawings, traveler, work instructions, and process specifications + Embraces good manufacturing practices and inspection… more
- Globus Medical, Inc. (Audubon, PA)
- …through design, prototyping, development, testing, design verification and validation, manufacturing , and product introduction. This individual will also ... Swiss Lathe is responsible for prototype fabrication to support product development. This includes bringing a product ...environment by regular cleaning and upkeep + Assisting in process / tooling development for manufacturing +… more