- Integra LifeSciences (Mansfield, MA)
- …skills or combination of relevant work experience and education. + Previous CAPA and/or quality systems /assurance experience and demonstrated use ... CAPA Specialist** is responsible for supporting the site Quality Management System (QMS) Corrective and Preventive Action (... quality tools/methodologies. + Detailed knowledge of FDA Quality Systems Regulations, GMP, ISO 13485 and… more
- Terumo Neuro (Aliso Viejo, CA)
- … Systems Engineer **Job Description:** This is a hands-on position in which the Senior Quality Systems Engineer is an active contributor to maintaining ... and improving quality systems to ensure compliance with global... Systems related discussion. Drives activities related to Quality System improvements. Job duties: + Maintains CAPA… more
- Integra LifeSciences (Mansfield, MA)
- …skills or combination of relevant work experience and education. + Previous CAPA and/or quality systems /assurance experience and demonstrated use ... outcomes and set new standards of care. **Summary** The ** Quality Systems II Engineer** is responsible for...QMS, having oversight of and ensuring compliance to the CAPA , NC and Quality Planning processes, and… more
- Caris Life Sciences (Irving, TX)
- …bigger than yourself, Caris is where your impact begins.** **Position Summary** Senior Software Design Quality Assurance Engineer thinks "outside the box" ... a Computer Systems Validation (CSV) and Computer Software Assurance (CSA) quality subject matter expert and to ensue organizational processes are followed and… more
- Parexel (Des Moines, IA)
- …at least 2 years of direct experience with developing and managing clinical quality systems and management of regulatory inspections. + Profound knowledge and ... understanding of clinical development programs, clinical trial processes as well as quality management systems and quality control tools is required. +… more
- Aequor (Thousand Oaks, CA)
- …execution of robust Deviations / CAPA process - Build and present quality records summaries for Senior Management review. Provide timely and comprehensive ... quality records (Deviations, Corrective and Preventive Actions (CAPAs), CAPA -Effectiveness Verifications, Supplier Event Notifications and Investigations (SICAR /EN),… more
- BeOne Medicines (San Mateo, CA)
- General Description: This position within R&D Quality is a senior Auditor role (as Lead or Co-auditor) who is responsible for independently overseeing and ... and necessary resources with relevant stakeholders: Review documentation, procedures, and quality management systems prior to conducting audits. + Conducting… more
- Coty (Sanford, NC)
- …in the analysis and disposition of non-conforming materials, including administration of SCAR and CAPA systems as needed. + Perform other duties as assigned or ... Senior Chemist **SR. CHEMIST** **QA - SANFORD, NC**...+ Process and Method Validation + Strong command of Quality Control processes/ systems . + Excellent application of… more
- RWE Clean Energy (Belle Center, OH)
- …permanent** **Functional area:** Health, Safety & Environment **Remuneration:** Exempt As the ** Senior Associate, HSSE Operations & Project Execution** , you will be ... KPIs and targets. You will support the implementation of HSSE management systems , processes, and programs across projects under development, project execution sites,… more
- Quad (Spartanburg, SC)
- …Job The Quality Manager - Packaging oversees and coordinates the Quality Systems program across multiple manufacturing facilities. This role develops, ... interprets, and implements companywide quality policies, manages quality systems ,...systems , and regulatory standards. Corrective & Preventive Actions ( CAPA ) + Initiate, distribute, track, and evaluate root cause… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …products. Supported by more than 40 manufacturing facilities, we provide high- quality medicines, trusted by healthcare professionals and patients, to more than ... on dermatology, ophthalmology and onco-dermatology. **Job Summary:** Supervise the Quality Control Laboratory activities and personnel, ensuring compliance is… more
- Endo International (Rochester, MI)
- …of successfully leading regulatory inspections and audits. + Strong experience with ** quality systems ** ( CAPA , deviation, change control, risk management, ... of preventive measures. Monitor changes in global regulations and proactively adapt site quality systems to maintain compliance. Leadership Serve as the primary … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Affairs programs. This role involves deputizing for the Sr. Director, representing the Quality organization at senior levels. The Director plays a pivotal role ... management within Medical Affairs teams for third-party/vendor activities, ensuring that quality standards are maintained in outsourced operations.Ensure CAPA … more
- Ralliant (Hollister, CA)
- …quality (COPQ), support new product introductions (NPI), and implement robust quality systems to meet customer and industry requirements. **Key ... instructions, and standard operating procedures (SOPs). + Prepare and present quality performance reports to senior management, highlighting trends, risks,… more
- Ralliant (Spartanburg, SC)
- We're looking for an experienced and results-driven ** Senior ** Quality Engineer to join our **Spartanburg, SC** team! In this role, you'll lead quality and ... expectations. **In this role you will:** + **Establish and implement quality practices** aligned with operations, customer expectations, and company standards.… more
- Teleflex (Wyomissing, PA)
- …including engineering drawings and specifications. - Aid in assessing and resolving product quality issues under guidance. - Assist in CAPA and NC documentation ... medical technologies, Teleflex is driven by our purpose to improve the health and quality of people's lives. Through our vision to become the most trusted partner in… more
- Terumo Medical Corporation (Elkton, MD)
- …and software validation. + Strong familiarity with quality management systems (QMS), including change management, design controls, CAPA , risk management, ... MD, US Company: Terumo Medical Corporation Department: TIS Design Assurance/ Quality Engineering Terumo Medical Corporation (TMC) develops, manufactures, and markets… more
- Integra LifeSciences (Plainsboro, NJ)
- …7 and ISO 5 Clean Rooms and with Good Manufacturing Practices (GMP), Quality Systems Regulations, Standard Operating Procedures (SOP's), and Health and Safety ... for CMC (Collagen Manufacturing Center) to ensure the safety, efficacy, and quality of our medical devices. This includes assigning and monitoring weekend (Friday… more
- Fresenius Medical Center (Ogden, UT)
- …System to ensure CAPA system is successful and compliant. Partners with Quality Systems personnel and responsible to drive continuous improvement on Root ... **PURPOSE AND SCOPE:** The CAPA Quality Engineers are assigned Corrective...as directed by immediate supervisor. + May refer to senior level staff for assistance with higher level problems… more
- LSI Solutions (Victor, NY)
- …the QMS. + Assist in the identification and implementation of improvements to the CAPA System. Senior + Directly facilitate and/or execute CAPA projects, ... state-of-the-art devices. After all, our customer is ultimately the patient. POSITION TITLE: CAPA Project Engineer (Days 8am to 5pm) SHIFT HOURS: 8:00am to 5:00pm .… more
