- Fresenius Medical Center (Waltham, MA)
- …a medium-sized company + Supporting the department in cross-site activities to monitor product quality and regulatory compliance **EOE, disability/veterans** ... + Experience in project management respectively change control process + Experience in regulatory affairs or in a quality environment, ideally in a… more
- Abbott (Westford, MA)
- …This position is responsible for developing, establishing and maintaining quality systems programs, policies, processes, procedures, training materials, and controls ... enhancing the performance and quality of products and the divisional capability to demonstrate...+ Provide expert level guidance and direction of the Quality Systems Body-of-Knowledge + Aggressively identify opportunities to apply,… more
- Fallon Health (Worcester, MA)
- … and internal- compliance audits. **Responsibilities** **Care Management (CM) Regulatory Manager Responsibilities Includes:** * Audits clinical documentation, ... and LinkedIn. **Summary of purpose:** The Care Management (CM) Regulatory Manager is an essential function to...improve their performance required - 3+ years experience in compliance , clinical quality , care coordination/case management in… more
- Hologic (Marlborough, MA)
- …recommendations on labeling, manufacturing, and analytical and clinical study plans for regulatory compliance + Maintains advanced working knowledge of laws, ... Manager , Regulatory Affairs (IVD On-Market/Sustaining) San...products, assess product or process changes, and participate in quality related activities (complaints, nonconformances, field actions, etc.) focused… more
- Grifols Shared Services North America, Inc (Worcester, MA)
- …more than 110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has ... interactions with regulatory authorities to expedite approvals. Participate in the development...May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams of… more
- Amazon (Westborough, MA)
- …The team is comprised of Hardware Engineering, Technical Program Management, Advanced Quality Planning, Safety & Compliance , Reliability, Strategic Sourcing and ... to help develop, review, consult and review engineering designs for compliance with applicable safety requirements, regulation and standards. Strong technical skills… more
- Hologic (Marlborough, MA)
- Global CAPA & Compliance Manager Marlborough, MA, United States Are you an experienced Quality leader with a passion for compliance and driving impactful ... change? Hologic is seeking a Global CAPA and Compliance Manager to oversee and ensure a...Cause Analysis tools and application of risk management to Quality Systems. + Familiarity with global regulatory … more
- Hologic (Marlborough, MA)
- …certainty and confidence. The Manager of Quality Engineering will lead quality strategies to ensure compliance with regulatory requirements and the ... Manager , Quality Engineering Marlborough, MA, United...those conducted by the FDA, notified bodies, and other regulatory agencies. + Quality System Compliance… more
- Hologic (Marlborough, MA)
- Manager , Supplier Quality Auditing Marlborough, MA,... Quality Sr. Director/Director that may affect product quality or regulatory compliance . + ... United States **Join Our Team as a Supplier Auditing Manager at Hologic** Hologic is seeking a committed Supplier...auditing program, ensuring that our suppliers adhere to rigorous regulatory and quality standards. You will lead… more
- Saint-Gobain (Worcester, MA)
- … plays a critical leadership role in ensuring the highest standards of product quality and regulatory compliance within the organization. This position is ... coaching, and development. + Ensure all personnel are trained and certified in quality systems, regulatory compliance , and EHS protocols. + Maintain… more
- Tecomet (Wilmington, MA)
- **POSITION SUMMARY:** The Quality Assurance Manager oversees the quality management system (QMS) and ensures compliance with AS9100 and other regulations ... Defense producers. This is an ITAR regulated site. The Quality Assurance Manager Quality Engineering...plans; + Coordinate internal and external audits (customer, supplier, regulatory , and third-party) to assess compliance and… more
- Bristol Myers Squibb (Devens, MA)
- …here at BMS with our Cell Therapy team. This is a key role on the Shop Floor Quality Assurance team. As Shift Manager for the A2 Shift (6pm to 6am), you will ... with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. The Manager , Shop Floor Quality Assurance, Cell Therapy is responsible for… more
- Danaher Corporation (Waltham, MA)
- …division producing Class I IVDs, ensuring compliance and excellence. The Quality Assurance Manager drives quality improvements for our customers ... audacious so we can truly drive science forward. The Quality Assurance Manager is responsible for overseeing...Systems (QMS) at Abcam's Waltham area site. + Assure compliance with applicable regulations, including ISO 13485, 21 CFR… more
- Fallon Health (Worcester, MA)
- …and ensuring competency and abilities, audits clinical documentation and ensures compliance to established competency standards and regulatory needs, working ... participant in regulatory audits such as NCQA, CMS, State Contract Compliance and other audits representing the Care Team which includes preparing documents for… more
- Fallon Health (Worcester, MA)
- …Founded in 1977 in Worcester, Massachusetts, Fallon Health delivers equitable, high- quality , coordinated care and is continually rated among the nation's top ... health plans for member experience, service, and clinical quality . We believe our individual differences, life experiences, knowledge, self-expression, and unique… more
- Sanofi Group (Framingham, MA)
- …assuring the security of the company's business and global markets. The Principal Compliance Specialist is responsible for providing quality support and guidance ... **Job Title:** Principal Compliance Specialist, Operations **Location:** Framingham, MA **About the...Quality role. + Working experience in external agency regulatory audits (FDA, EMA, etc.). + Demonstrated experience guiding… more
- Beth Israel Lahey Health (Burlington, MA)
- …in conjunction with the Nursing Supervisor ** QUALITY IMPROVEMENT:** A. Monitors compliance to regulatory criteria and standards of care. B. Reviews outcome ... people's lives.** Under the general direction of the Nurse Manager the Assistant Nurse Manager (ANM) practices...responsibility include: . Clinical practice . System coordination . Quality improvement . Human resource management . Unit budget… more
- MIT Lincoln Laboratory (Lexington, MA)
- …will include overseeing data governance policies, ensuring compliance with regulatory requirements, and facilitating data quality initiatives. You will work ... Job Description We are seeking a motivated and experienced Manager of Finance Data and Governance to join our...organization. + Manage regular reviews of data to assess compliance with data governance policies and regulatory … more
- AbbVie (Worcester, MA)
- …Portfolio by integrating the efforts of all stakeholders including R&D, S&T, Quality , Production, Supply Chain, Engineering and Regulatory . Responsibilities: + ... and milestones, integrating the needs of process development, supply chain, engineering, quality , regulatory and production. + Proactively identify and drive… more
- Beth Israel Lahey Health (Burlington, MA)
- …supervises all nursing staff in assigned clinical patient care units/departments to provide quality patient care. The Nurse Manager maintains a current level of ... accountability are central to the delivery of individualized high quality patient care. As Lahey continues to grow, we...Chief Nursing Officer (ACNO) and Nursing Directors, the Nurse Manager is responsible for day to day operations, practice… more