- Novo Nordisk Inc. (West Lebanon, IN)
- …floor support for the manufacture of our products for our patients. The engineer collaborates with all customers on site and facilitates the delivery of solutions ... developing the talent within the department. Relationships Reports to: Lead Engineer Number of subordinates with direct/indirect referral: none Essential Functions… more
- Philips (Cambridge, MA)
- **Senior CAPA Engineer ** **In this role you** The Senior CAPA Engineer is responsible for driving CAPA activities from issue identification to ... closure, effectively project managing all CAPA activities, ensuring the quality of CAPA record content and representing CAPAs during audits and CAPA Review… more
- Integra LifeSciences (Plainsboro, NJ)
- …pathways to advance patient outcomes and set new standards of care. The **Facilities CAPA Engineer II** plays a crucial role in ensuring compliance and ... satisfactorily. Primary responsibilities are to: + Non-conformance, Deviation, Investigation and CAPA point of contact for those items assigned to the Engineering… more
- LSI Solutions (Victor, NY)
- …state-of-the-art devices. After all, our customer is ultimately the patient. POSITION TITLE: CAPA Project Engineer I/II Days (8am to 5pm) LOCATION: Onsite at ... in Victor, NY SALARY RANGE: $72,000 - $97,000 JOB SUMMARY: The CAPA Project Engineer combines elements of process and project engineering. Leads the corrective… more
- Philips (Cambridge, MA)
- **Sr. Quality Engineer - CAPA Expert** **In this role you** CAPA subject matter expert who can confidently advise and critically review Corrective and ... Preventive Actions (CAPAs) in various stages of the CAPA workflow and facilitate CAPA investigations from...stages of the CAPA workflow and facilitate CAPA investigations from issue identification through implementation of solution… more
- Cook Medical (Bloomington, IN)
- Overview The Quality Engineer serves as the quality mentor and/or reviewer for all CAPA and RIC activities. Responsibilities * Perform work per external and ... root cause analysis of product or process CAPAs* Mentor CAPA owners in the use of root cause investigation...ISO 13485, and other applicable regulatory requirements Qualifications * Engineer degree or a Technical Life Science degree* Demonstrates… more
- Takeda Pharmaceuticals (Lexington, MA)
- …appropriate corrective actions + Complete action items for GMP investigations and CAPA 's + Assist supervisor/ engineer /facilities with investigations + Revise and ... author GMP documentation + Communicate any quality issues/concerns to Supervisor **What you bring to Takeda:** + Normally requires a high school diploma and 6+ years related industry experience or an Associate's Degree in Life Sciences/Engineering field with 5… more
- Terumo Medical Corporation (Elkton, MD)
- Sr Quality Systems Engineer Date: Oct 19, 2024 Req ID: 3578 Location: Elkton, MD, US Company: Terumo Medical Corporation Department: Quality Systems & Compliance ... healthcare with heart_** **Job Summary:** The Senior, Quality Systems Engineer shall drive TMC's efforts to ensure compliance with...and effectiveness of the Quality Management System, primarily the CAPA system by: + Providing guidance to CAPA… more
- Terumo Medical Corporation (Elkton, MD)
- …Medical Corporation Department: Quality Systems & Compliance **Job Summary:** The Quality Systems Engineer II drive TMC's Corporate CAPA Program to ensure it is ... Quality Systems Engineer II Date: Oct 19, 2024 Req ID:...and effectiveness of the Quality Management System, primarily the CAPA system by: + Establishing and maintaining CAPA… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …it is likely not legitimate._ **Job Description** The Principal Quality Engineer , Complaint Management Compliance is an experienced professional with wide-ranging ... experience and expertise in CAPA to ensure regulatory compliance and patient safety **Job...investigation, and resolution of quality issues. + Follow global CAPA procedures and guidelines in alignment with regulatory requirements.… more
- Boehringer Ingelheim (Fremont, CA)
- …reflect Boehringer Ingelheim's high regard for our employees. The Senior Engineer , DS Plant Engineering is an expert in biotechnology manufacturing equipment ... of new process equipment and modifications to the manufacturing facility. The Engineer , DS Plant Engineering is responsible for ensuring process equipment readiness… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- **Job Description Summary** Develop and sustain quality system CAPA and processes for the Design Center that comply with applicable regulations and standards, ... with us. **Job Summary:** As a Sr. Quality Systems Engineer , you will be responsible for planning and implementing...will be responsible for planning and implementing corrective actions ( CAPA ) to address quality issues including and developing and… more
- Zimmer Biomet (Warsaw, IN)
- …valued, and have a strong sense of belonging. **DUTIES** The Quality Senior Engineer II will be responsible for gathering relevant, factual information and data in ... regulated industry experience; total engineering project experience including leading CAPA Process Using DMAIC methodology, root cause analysis utilizing efficient… more
- West Pharmaceutical Services (Scottsdale, AZ)
- …strategies for various projects. + May review and approve Complaint, CAPA , Audit Findings, Issue Reviews, Non-conformances investigations to provide guidance to ... SME, Reviewer, etc. + May manage key quality system programs such as CAPA , Quality Culture initiatives, Non-conformance or other QMS elements programs that are to… more
- Medtronic (Boulder, CO)
- …where you can thrive. **A Day in the Life** The Principal Quality Engineer develops and maintains quality assurance programs to ensure that the performance and ... established standards and agency guidelines. Primary job responsibilities include CAPA management, audit program management and Quality Management System… more
- LSI Solutions (Victor, NY)
- …devices. After all, our customer is ultimately the patient. POSITION TITLE: Quality Assurance Engineer I / II Days (8am to 5pm) LOCATION: Onsite at LSI Solutions in ... NY SALARY RANGE: $72,000 - $106,000 JOB SUMMARY: The Quality Assurance Engineer provides quality engineering support to ensure regulatory compliance and industry… more
- Nissha Medical Technologies (Panton, VT)
- Quality Engineer Summary **Title:** Quality Engineer **ID:** 2639 **Department:** Quality **Location:** Paignton, England Description **Job Summary** To drive ... implement containment, corrective and preventive actions. **Key Duties/Responsibilities** 1. CAPA investigation; 2. Quality Complaint investigation 3. Change Management… more
- Integra LifeSciences (Plainsboro, NJ)
- …outcomes and set new standards of care. **SUMMARY DESCRIPTION** The **Quality Assurance Engineer II** will provide Quality compliance support on all aspects of the ... Plainsboro, NJ CMC Quality System. The Quality Assurance Engineer II will monitor, prioritize and track the timely...for the quality efforts in other areas of the NC/ CAPA system, including Complaints. Monitor, prioritize and track the… more
- Actalent (Cranston, RI)
- Job Title: Quality Engineer Job Description We are seeking a dedicated Quality Engineer to join our dynamic team. This role involves implementing and managing ... CAPA processes, conducting root cause analysis, and performing data...and maintain and update quality documentation. Additionally, the Quality Engineer will provide training and support to production staff.… more
- Abbott (Westbrook, ME)
- …of diseases and other conditions. The position of **Manufacturing Line Quality Engineer Supervisor** is within our Infectious Disease Developed Markets business unit ... support staff training and development needs. The **Manufacturing Line Quality Engineer Supervisor** is accountable for providing Quality Assurance expertise and… more
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