- Cambridge Isotope Laboratories, Inc. (Tewksbury, MA)
- Cambridge Isotope Laboratories (CIL) has an outstanding opportunity for a Quality Assurance Specialist I to join the team responsible for the quality of ... Review Reports, as needed + Contributor to various QA Quality Program functions when needed (eg Deviation, CAPA, Supplier... Assurance and knowledge and/or experience in ICH Q7, ISO 13485, is preferred + Excellent interpersonal, verbal and… more
- Integra LifeSciences (Boston, MA)
- …with Integra's internal operational laboratories to implement programs to improve their quality , reliability, and throughput. The Sr. Lab Specialist will be ... responsible for implementing continuous improvement programs, identifying and tracking quality and operational key performance indicators, implementing compliance programs,… more
- Philips (Cambridge, MA)
- The Principal Regulatory Affairs Specialist will play a critical role in preparing comprehensive regulatory strategies for complex new devices and post market ... as CE Marking and product registrations, clinical evaluations in accordance with EU MDR, ISO 13485, and ISO 14155, China NMPA, Canada, Japan JPAL, compliance… more
- Actalent (Bedford, MA)
- Job Description Quality System requirements, cGMP, FDA and ISO 13485 standards. Areas of responsibilities include receipt and review of documents such as charts, ... the medical device and/or pharmaceutical industries working in Quality Assurance/ Quality Compliance role. Knowledge of GMP, FDA, ISO requirements. Requires… more
- Teleflex (Chelmsford, MA)
- …make a difference in patients' lives. **Position Summary** The Document Control & Records Specialist will support the Quality Team and will be responsible for ... Documentation Control and Records Specialist **Date:** Jul 17, 2024 **Location:** Chelmsford, MA,...work in a fast-paced dynamic environment. * Knowledge of Quality Management Systems under ISO 13485:2016 *… more
- Actalent (Bedford, MA)
- … Assurance/ Quality Compliance role. + Knowledge of GMP, FDA, ISO requirements. + Requires computer competence, including experience with database and Microsoft ... needed. + Review and approve incoming materials for release. + Provide quality assurance support of investigations including: nonconformance and root cause analysis.… more
- Travelers Insurance Company (Boston, MA)
- …negotiating and resolving assigned serious and complex subrogation claims. Provides quality claim handling throughout the claim life cycle (customer contacts, ... and resolution) including maintaining full compliance with internal and external quality standards and state specific regulations. Provides consulting and training… more
- Danaher Corporation (Boston, MA)
- …in global IVD regulations, quality standards and product development process such as ISO 13485, US FDA 21 Part 820, IVDR, design control, risk management, etc. + ... solutions that safeguard and improve human health. This position is part of the Quality Assurance and Regulatory Affairs group located in Coralville, IA , USA and… more
- Stellant Systems (Topsfield, MA)
- **Overview** **Job Title:** Sr Quality Manager **Internal Job Title:** Senior Manager, Quality **Location:** Topsfield, MA **Salary:** $100,000-$120,000/yr ... detect, protect, and connect. **Responsibilities** Stellant Systems is seeking a talented **Sr Quality Manager** at our Topsfield, MA location to direct quality … more
- Black & Veatch (Burlington, MA)
- …for safety and regulatory standards (IEEE, IEC, NEC, NESC, NERC, ISO /RTO) to effectively define project requirements, review project deliverables (physical, P&C, ... Black and Veatch policies and procedures relative to assigned tasks Quality /Continuous Improvement: + Consistently and independently applies knowledge and complies… more
- RTX Corporation (Andover, MA)
- …Summary: As a part of the Supplier Material Verification Team, this Principal Specialist of supplier quality inspection position is responsible for the ... Raytheon systems (PRISM, PDM, VBS) + Metrics-driven + Familiarity with ISO 9001 and/or AS9100 quality management systems + Knowledge of Supplier Quality … more
- Orchard Therapeutics (Boston, MA)
- …clinical team to provide key expertise in study specific, potentially specialist , bioassay set-up and implementation. Key elements and responsibilities . Serve ... as part of laboratory routine work o laboratory compliance/accreditation requirements (eg CLIA, ISO 15189) o global (US, EU, UK) LDT/IVD development o assay transfer… more
- Xerox (Boston, MA)
- …Thursday, July 25, 2024 Working time Full-time Ref# 20033706 Job Level Specialist Job Type Experienced Job Field Information Management Seniority Level Mid-Senior ... Contributes to the development and promotion of the technical specialize. Recommends quality standards and policies relating to the technical specialize. + Maintains… more
- CDM Smith (Boston, MA)
- …and/or US Society on Dams (USSD) - -\tServe as a technical specialist in the application of advanced geotechnical engineering theories, concepts, principles, and ... research and development projects - Embrace continuous improvement, drive a culture of quality , and meet commitments for sustained success - Work with clients in the… more
- ConvaTec (Lexington, MA)
- …across Convatec's Business Units. Reporting to the Clinical Study Management Specialist , this role will ensure clinical study execution is timely, cost-effective ... and in accordance with Convatec's policies and procedures, ISO , FDA and local regulations. **Key Responsibilities:** + Proactively...of processes and SOPs, with input on discussions around quality by design and operational delivery. + May be… more
- RTX Corporation (Woburn, MA)
- …Manual (NISPOM), and/or non-defense regulations such as FAA, Payment Card Industry (PCI), ISO 9001 Quality Management standards, or HIPPA + Experience working ... an Information System Security Officer (ISSO) known as a Principal Specialist within the organization. The ISSO will support classified computing environments… more
- BD (Becton, Dickinson and Company) (Woburn, MA)
- …of all phases of work for Contractor: JLL + Supervise 2 Facilities Technician/ Specialist and 1 EHS Site Lead + Provide monthly look-ahead of planned maintenance ... improvement mentality, by recommending and implementing improvements in Safety, Quality , Cost, Inventory, Delivery + Work with team members...device manufacturing as it relates to FDA, GMP's and ISO + Ability to communicate well, both orally and… more