- Actalent (New Prague, MN)
- …and mention this job posting to be considered immediately! Description: The Post Market Surveillance Specialist is integral in managing ... in audits to enhance organizational compliance and efficiency. The Post Market Surveillance Specialist is...+ Collaborate with the Head of Regulatory Affairs and Quality Assurance (RA/ QA ) to interpret… more
- Olympus Corporation of the Americas (Westborough, MA)
- …needed to support both local and global targets and objectives. + Work with the Post - Market Surveillance department to establish tools and methods needed to ... Manager, Senior Global MDR Submission is responsible for managing Market Quality - COE MDR team for the... Quality System Regulations (QSR ) compliance and quality assurance . + Demonstrated experience leading global… more
- Terumo Medical Corporation (Elkton, MD)
- …Interventional Systems and Terumo Medical Products. **Job Summary:** The Manager Quality Engineering, Post Market Surveillance will manage the Post ... Location: Elkton, MD, US Company: Terumo Medical Corporation Department: Post Market Surveillance Terumo Medical...Work in a team environment with members of the Quality Assurance group on achieving team metrics… more
- Danaher Corporation (Washington, DC)
- …to relentlessly reimagine healthcare, one diagnosis at a time. You will be a part of the Post Market Surveillance Quality team and report to the Post ... tools that address the world's biggest health challenges. The Quality Assurance Scientist II for Beckman Coulter...Customer Feedback (CF). This position is part of the Post Market Surveillance located at… more
- Mallinckrodt Pharmaceuticals (St. Louis, MO)
- …Responsible for the coordination of compliance related activities within the Post - Market Surveillance -Product Monitoring (PM) department; this includes, ... performance. + Involved in Business Development & Licensure activities as they pertain to Post - Market Surveillance data. + Involved with the execution of… more
- Olympus Corporation of the Americas (Westborough, MA)
- …+ Strong prior experience in Quality Assurance initiatives including post market surveillance , complaints management, quality KPls, Design ... to Life.** **Job Description** The Sr. Manager, Business Development Quality Assurance will support Quality ...Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs ( QA… more
- Abbott (Alameda, CA)
- …processes and programs to ensure new products are capable for post - market surveillance as defined in the ADC Quality System at the time of launch. This ... effective team oversight of new product development to ensure post - market surveillance capabilities at time...identify CAs to resolve. * Collaborate with Operations, R&D, Quality Assurance , and Customer Service to determine… more
- Fresenius Medical Center (Lawrence, MA)
- …for the implementation of appropriate cybersecurity measures . Evaluation of events ( post - market surveillance ) within the scope of complaints/incidents and ... (DMR) reviews meetings and fully understand the design control process and Quality Engineering. Utilize technical training and compliance experience to ensure that… more
- Belcan (Marlborough, MA)
- …medical device, pharmaceutical) * Minimum 7 years relevant experience dealing with post market surveillance activities (complaint triage, investigations, ... Quality Inspector Job Number: 348145 Category: Quality...with cGMP and/or ISO 13485 including documentation, audit, and post market surveillance * Demonstrated… more
- Integra LifeSciences (Boston, MA)
- …individual contributors and team members + Assist or lead customer complaint investigations and post - market surveillance activities. + Assist or lead in the ... activities around non-conformances and CAPA's. Works collaboratively with Manufacturing, Engineering, Quality Assurance , and other functional experts to support… more
- Hologic (San Diego, CA)
- …control of nonconforming products, CAPAs, deviations, complaints management, complaint investigations, post - market surveillance , audits, quality system, ... document control, incoming inspections, product release, and other Quality Assurance related processes and teams. * Ensures the risk management program is… more
- Teleflex (Chelmsford, MA)
- …will support the Operations, Engineering, R&D, and Post Market Surveillance team activities to ensure that product quality and services are achieved ... Quality Engineer will be responsible for cross-functional quality assurance , quality management/compliance, ...change controls (ADC/ECOs) as needed. * Training - Perform QA training certifications on new production operators as needed.… more
- Integra LifeSciences (Cincinnati, OH)
- …Quality Control. Works closely with Operations, Manufacturing Engineering, Design Engineering and Post - Market Surveillance groups to ensure a high level ... external) + Member of Internal Audit Team + Other Quality duties as assigned by Director of QA...this position. **Education & Experience** + Bachelor's degree in Quality Assurance or Engineering or related discipline.… more
- Actalent (Santa Clara, CA)
- …requests etc. * Support Quality Compliance activities by extracting and analyzing post market surveillance (PMS) data to support the PMS plans/reports, ... * Other duties as assigned Skills: Data, Data entry, Quality assurance Additional Skills & Qualifications: Requirements:...specialized experts who drive scale, innovation and speed to market . With a network of almost 30,000 consultants and… more
- Actalent (Aurora, CO)
- …the EU declaration of conformity are drawn up andkept up to date o The post - market surveillance obligations are complied with in accordance with the ... assure that effective corrective action is implemented o Serve as primary Quality Assurance Manager for problem identification, resolution, and continuous… more
- Hologic (Newark, DE)
- …analysis and resolution. + Work with Post Market Surveillance and other applicable departments ( Quality Engineering, MFG Engineering, Research, and ... Engineer Certificate (Desirable). + 2 or more years of experience in Quality Assurance of material manufacturing technology including electronics and metals. +… more
- Actalent (Emerson, NJ)
- …documentation files, including 510(k) + submissions, Device Master files, technical files and post market surveillance for product changes + and/or new ... quality /regulatory related issues + Support international RA and QA efforts and collaborate with other teams across the...specialized experts who drive scale, innovation and speed to market . With a network of almost 30,000 consultants and… more
- Teleflex (Mansfield, MA)
- …management reports to assess the risks associated with a product. * Analyze post - market surveillance data periodically throughout a product's lifecycle to ... as part of a cross-functional team. * Partner with Product Quality Assurance and Operations to make risk-based decisions associated with nonconformances and… more
- Insight Global (Franklin Lakes, NJ)
- …provide support to guide/implement innovation, product development, clinical testing, manufacturing, and post market surveillance to ensure completion of ... to complex projects involving multiple internal clinical studies/evaluations Implements and documents Quality Assurance and Quality Control procedures as… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …commercial products.** **Maintain Risk Management Files for existing products based on post market surveillance .** **Facilitate design transfer of existing ... with key technical counterparts within the Regeneron organization, including quality assurance , external manufacturing, and various engineering functions,… more