- Curia (Albuquerque, NM)
- …engineers and technicians, fostering skill development and knowledge sharing. + Support Validation and Computer Systems Validation activities to ensure ... objectives. + Lead complex projects with minimal oversight, balancing quality, validation , production, and regulatory considerations in all decision-making. + Mentor… more
- Hologic (Newark, DE)
- …lead design controls, risk management processes, and rigorous verification and validation (V&V) strategies, ensuring our software meets the highest global regulatory ... innovation. **Knowledge:** + Deep understanding of global medical device software regulations, including FDA 21 CFR Part 820, EU MDR, ISO 13485, and IEC 62304. +… more
- Contract Pharmacal Corp (Hauppauge, NY)
- …include, but are not limited to: + Knowledge of USP and FDA requirements. + Develop stability-indicating methods for Active Pharmaceutical Ingredients (API) and ... Dietary Supplement products. + Generate method validation protocols. + Execute methods validation and methods transfer. + Generate method validation reports… more
- Integra LifeSciences (Princeton, NJ)
- …+ Participate in design and change control activities. + Participate in FDA inspections, ISO Certification and Surveillance audits and Internal audits. + Collaborate ... product development, product realization, design transfer, design verification and validation . + Experience leading engineering product development teams, experience… more
- Amgen (New Albany, OH)
- …maintained in compliance with all applicable industry standards, regulatory standards and FDA standards in the Inspection and Packaging area. The work schedule for ... on engineering, regulatory, compliance, calibration, quality, microbial/environmental, technical cleaning, validation , electrical and process automation issues. + Assistduring regulatory… more
- Abbott (Santa Clara, CA)
- …development and delivery, including data ingestion, feature engineering, training, validation , deployment, and monitoring. + Architect a highly available, secure, ... reviews. Required Qualifications + Bachelors Degree ( +/- 16 years) in Computer Science, Engineering Mathematics, or related field + Minimum 10 years with… more
- J&J Family of Companies (Danvers, MA)
- …processing) for precise system operation. + Ensure compliance with IEC 62304, FDA design controls, and other applicable regulatory standards. + Develop and maintain ... in team meetings. **Qualifications:** + Bachelor's or Master's in Computer Science, Electrical/ Computer Engineering, or Embedded Software Engineering.… more
- DRT Strategies, Inc. (Silver Spring, MD)
- …make vision a reality. Project Description: This project is designed to support FDA CDER Office of Quality Surveillance (OQS) with developing and implementing modern ... serves as a technical specialist leveraging expertise in data science, computer science, mathematics, and statistics to transform complex clinical data into… more
- Globus Medical, Inc. (Methuen, MA)
- …+ Support design transfer from R&D to production under ISO 13485 and FDA guidelines. + **Regulatory & Quality Compliance** + Ensure adherence to IEC 62304 ... cybersecurity standards. + Maintain documentation for design controls, verification, and validation activities. + **Innovation & Research** + Stay current with… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …a drug product that is safe for human use. + Executes commissioning and validation activities associated with a new building. This job description is intended to ... + Excellent oral and written communication skills. + Comfortable with using different computer systems to perform data entry. + Willingness to work with and learn… more