- Integrated Resources, Inc (Rocklin, CA)
- …Summary of Safety and Performance reports o Risk Management plans, reports, FMEAs o Post - Market Surveillance plans and reports o Performance evaluation plans ... Job Title - Quality Systems Specialist Job Location - Rocklin, CA...Responsibilities: . Directly responsible for ensuring documents submitted to Quality are compliant to company procedures, regulatory requirements, and… more
- Ecovyst (Martinez, CA)
- …as listed is $95,000 to $125,000 annually. * Our salary ranges are determined by market data based on position and level. The range displayed on each job posting ... vibration analysis, ultrasonic inspection, thermography, and oil analysis.Provides equipment surveillance to assure performance as expected or impending issues are… more
- Franklin Energy (Chicago, IL)
- …product vision and solution architecture, ensuring our software not only meets market needs but sets new standards in the industry.Essential Duties and ... in Agile development processes, enhancing team collaboration and product quality through effective leadership.Translate complex customer feedback and analytical data… more
- AbbVie (Jersey City, NJ)
- … Quality Index, Site Business Review, Quality Systems Management Review, and Post Market Surveillance Review. + Provide in-depth insights for each ... Branchburg in above-site reviews when required. Own and maintain procedures for Post Market Surveillance , Quality Management System Review, and other… more
- Cook Medical (Bloomington, IN)
- …external Audit programs, NC/CAPA processes, Document Management, Management Review, Post Market Surveillance , and Quality Systems Projects. - Moniter, ... Overview The Senior Manager, Quality Assurance serves on a cross functional team...including premarket/ product development, supplier management, manufacturing, sterilization, and post - market .- Working with subject matter experts, process… more
- Hologic (San Diego, CA)
- …control of nonconforming products, CAPAs, deviations, complaints management, complaint investigations, post - market surveillance , audits, quality system, ... Senior Director, Quality San Diego, CA, United States The Senior... Assurance/Regulatory Compliance management for the design, production, and on- market support of medical or IVD products * Proven… more
- Zimmer Biomet (Jacksonville, FL)
- …- market surveillance + Trains and supports Zimmer Biomet Post Market Surveillance and Quality team with product investigations + May serve as ... capability) and inspection + Identifies and documents critical to quality product features based on product intended use, design...clinical study plans and protocols for both new and market released products for regulatory submission and post… more
- Zimmer Biomet (Warsaw, IN)
- …- market surveillance + Trains and supports Zimmer Biomet Post Market Surveillance and Quality team with product investigations + May serve as ... capability) and inspection + Identifies and documents critical to quality product features based on product intended use, design...clinical study plans and protocols for both new and market released products for regulatory submission and post… more
- Olympus Corporation of the Americas (Westborough, MA)
- …preferred). + Strong prior experience in Quality Assurance initiatives including post market surveillance , complaints management, quality KPls, ... staying **True to Life.** **Job Description** The Sr. Manager, Business Development Quality Assurance will support Quality Assurance M&A activities throughout… more
- Cook Medical (Bloomington, IN)
- …supports additional process such as Supplier Quality , Internal Audit, CAPA, and Post Market Surveillance . The Manufacturing Quality Engineer fulfills ... Overview The Manufacturing Quality Engineer serves as the lead quality representative of assigned product lines for new product development, day to day… more
- Danaher Corporation (Westborough, MA)
- …pharmaceutical) preferred + At least 3 years relevant experience dealing with post market surveillance activities (complaint triage, investigations, CAPA, ... develop the next generation of life-changing therapeutics. The Senior Quality Assurance Product Surveillance Lead for Cytiva...with cGMP and/or ISO 13485 including documentation, audit, and post market surveillance preferred +… more
- Bill and Melinda Gates Foundation (Seattle, WA)
- …innovative platform interventions and functions - such as collaborative disease surveillance - that support across the foundation's more specific global health ... and agenda setting to support global coordination on disease surveillance , and align global funding sources to enable countries...and actionable for public health decisions. In addition, the post holder will be the primary focal point for… more
- Lundbeck (Deerfield, IL)
- …health. + Global pharmacovigilance experience supporting EU or Asia + Pre and post market surveillance experience **TRAVEL:** + Willingness/Ability to travel ... Director Safety Surveillance US - Remote Opportunity Requisition ID: 5214...teams. The incumbent will maintain oversight of safety related post approval commitments, risk minimization activities and any mandated… more
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …and analysis for failure investigations. + Responsible for reporting in Post Market Surveillance Reviews and Quality Management Reviews. + Responsible ... resolutions. Primary Duties + Perform all work in compliance with company quality procedures and standards. + Directs cross-functional teams through 8Ds, CAPAs, and… 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...care by ensuring timely, thorough investigations and resolutions of post - market quality and safety issues.… more
- Hologic (Newark, DE)
- …analysis and resolution. + Work with Post Market Surveillance and other applicable departments ( Quality Engineering, MFG Engineering, Research, and ... Supplier Quality Engineer Newark, DE, United States There has...relevant experience, skillset, knowledge, geography, education, business needs and market demand. Agency and Third-Party Recruiter Notice: Agencies that… more
- Abbott (St. Paul, MN)
- …life cycles. Writes/manages Periodic Safety Update Reports (PSUR), Canada Summary Reports (CASR), Post - Market Surveillance (PMS) Report, and PMS Plans, and ... help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with...from routine fingersticks. **The Opportunity** We are seeking a ** Post - Market Safety Evaluation Principal Medical Writer** to… 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 ... with our new sensing technology. As the Manager Product Quality Engineering, Complaints you will be responsible for the...effective team oversight of new product development to ensure post - market surveillance capabilities at time… 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 ... Description** The Manager, Senior Global MDR Submission is responsible for managing Market Quality - COE MDR team for the regulatory assessment and submission of… more
- Mallinckrodt Pharmaceuticals (Chicog, WI)
- …colleagues, including those responsible for but not limited to Product Performance, Device Quality , Post Market Surveillance , Device Development, ... guides and supports manufacturing teams across design, sustaining, manufacturing, and quality engineering to meet business objectives for quality , customer… more
