- Windstream Communications (Boston, MA)
- Quality Assurance Specialist Arkansas, USA * Georgia, USA * Iowa, USA * North Carolina, USA * Ohio, USA * South Carolina, USA * United StatesReq #1479 Tuesday, ... Role:** We are seeking a dedicated **Internal and Vendor Quality Assurance Specialist ** to oversee Kinetic's internal...methodologies and tools, such as TQM, Six Sigma, or ISO standards. + Excellent analytical skills and the ability… 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
- Baystate Health (Springfield, MA)
- Baystate Health, a nationally recognized leader in healthcare quality and safety, and home to Baystate Medical Center (BMC), and the region's only level 1 trauma ... services throughout western Massachusetts is looking for **Clinical Research Systems Specialist .** **Summary Description:** The Office of Research is seeking a full… more
- Dentsply Sirona (Waltham, MA)
- …portfolio of world class brands. Dentsply Sirona's products provide innovative, high- quality and effective solutions to advance patient care and deliver better ... someone to join our team as a Senior Technical Specialist in our Machining department. This position is scheduled...new equipment/processes transfer from Operations Engineering to production following ISO 13485 and FDA GMP standards. + Support the… more
- Galvion (Marlborough, MA)
- …and tactical operator. PRIMARY EMPLOYMENT OBJECTIVES The Document Control Specialist is responsible for managing timely, accurate, and efficient development ... and maintenance of engineering, operations and quality documentation according to legal and company regulations. Organize...in the existing document control system. + Assist in ISO Internal and External audits with document retrieval. +… 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
- ZOLL Medical Corporation (Chelmsford, MA)
- …resides in ZOLL's Post Market Surveillance program designed to meet FDA's Quality System Regulation (QSR)/ Good Manufacturing Practices (GMP), MDD, EU MDR, MDSAP, ... and the globally harmonized standard ISO 13485. This person will work with surrounding departments...This person will work with surrounding departments such as Quality Assurance, Compliance, Technical Support, Service, and Regulatory Affairs.… more
- System One (Burlington, MA)
- Title: Senior Regulatory Affairs Specialist -Animal Tissue Location: Burlington MA Schedule: Monday through Friday on site Terms: Direct Hire Education: Bachelor's ... for regulatory activities related to Animal Tissue Familiar with ISO 22442 requirements and its application in medical devices....get work done more efficiently and economically, without compromising quality . System One not only serves as a valued… more
- Fresenius Medical Center (Lawrence, MA)
- …regarding regulatory matters + Expertise in working within Medical Device Regulations including Quality System Regulation 21 CFR Part 820, ISO 13485, EU MDD/MDR, ... for NxStage Medical, Inc. products and provide regulatory input into key quality system processes, such as design controls, change control, labeling and advertising,… more
- Bausch + Lomb (Boston, MA)
- …for prescription drugs and consumer products. The team liaises with R&D and Quality organizations to prepare and maintain CMC sections of submissions and respond to ... (planning, authoring, reviewing, coordination, submission) for assigned projects/products. Make quality regulatory decisions, balancing risks and benefits with supervisor… more
- Fresenius Medical Center (Lexington, MA)
- PURPOSE AND SCOPE: The Senior Quality Specialist plays a pivotal role in maintaining and enhancing the quality management system (QMS) within the IT ... systems in IT. + Gained knowledge in GxP compliant documentation and quality management systems ( ISO 9001, GMP, ISO 13485) as well as documenting… 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
- Medtronic (Boston, MA)
- …FDA guidance and other relevant international standards (eg, IEC 62366, IEC 60601, ISO 14971) * Experience with risk analysis as specifically applied to human ... and written communication skills required * Detail-oriented with strong commitment to quality and to the workplace with the ability to efficiently multitask *… more
- RTX Corporation (Andover, 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
- 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
- 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