- Globus Medical, Inc. (Audubon, PA)
- …we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the ... lives as quickly as possible. **Position Summary:** As a Group Manager of Software , you will be responsible for planning, managing and implementing all aspects of… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- **Job Description** We're looking for a Principal Software Engineer to join our growing team and lead the development and strategy for our Digital Medicine ... commitment to collaborative problem solving, sophisticated design, and the creation of quality products are essential. Your team's primary focus is building core… more
- RELX INC (Horsham, PA)
- Director of Research and Software Engineering for Life Sciences Are you ready for a leading role? Would you enjoy working on our cutting-edge products? About Us At ... concepts. About the Role The Director of Research & Software Engineering will lead the development of our regulated...ensures compliance with industry regulations (such as GxP and FDA 21 CFR Part 11), oversees daily operations, drives… more
- Eliassen Group (Harrisburg, PA)
- …and implement new technologies to strengthen development efficiency * You'll interface with software test to ensure high quality product * You will develop ... ** Software Engineer** **Anywhere** **Type:** Contract-to-Hire **Category:** Development **Industry:**...PLUS: Bluetooth experience & Any industry experience that has FDA requirements OR enterprise level company experience and documentation.… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …capture improvement opportunities including non-product softwareEssential Functions + Performs internal quality audits and effectiveness reviews ( FDA 's QSR, ISO ... + Prepare, submit and coordinate the process validation requirements for non-product software validations + Participates in the FDA premarket approval process… more
- Glenmark Pharmaceuticals Inc., USA (Allentown, PA)
- …for investigation and Regulatory Affairs for arranging more information/ samples from FDA . + Managing Quality Management Review meetings, circulating minutes of ... Quality Compliance Manager Department: Quality Location:...Product Recalls, making sure no delay in submission to FDA per defined timeline. After initial submission, keeping track… more
- PCI Pharma Services (Philadelphia, PA)
- …years related experience in a regulated environment + Demonstrated expertise in quality management systems and regulatory requirements ( FDA , ISO 13485, Medical ... written and verbal communication skills + Advanced computer skills and proficiency with quality management software \#LI-LM1 Join us and be part of building… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …obligations, and performs clinical assessments as requested. The ability to maintain quality documents to ensure compliance with FDA regulations and guidance ... and literature reviews). The Analyst III requires a thorough understanding of FDA regulatory requirements for complaint handling and MDR reporting per ISO13485,… more
- Berry Global (Brookville, PA)
- …improved quality efficiencies. + Reviews and approves manufacturing processes, equipment, software changes to ensure that quality requirements are met. + ... for Team Amcor, visit www.amcor.com | LinkedIn | YouTube **Responsibilities** The Quality Engineer is responsible for implementation and enforcement of Quality … more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients ... (https://www.zoll.com/products/supersaturated-oxygen-therapy/therox-sso2-system) Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to… more