- Merck & Co. (Rahway, NJ)
- Job DescriptionThis Senior Engineer position will provide engineering support to the Rahway, NJ FLEx (Formulation, Laboratory & Experimentation) center, ... (QN) reporting, investigations, and any related corrective action/preventive action ( CAPA ).- Facilitate equipment/system changes, execute periodic reviews and support… more
- LanceSoft (Dexter, MI)
- …years of work experience in Engineering and/or Quality. Expertise in CAPA compliance & investigation techniques. Auditing experience to 21CFR820.30, 21CFR820.100, ... recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of… more
- Katalyst HealthCares and Life Sciences (Round Lake, IL)
- …execution of packaging projects for a variety of project types including Quality/ CAPA , Regulatory Compliance, Supplier Notices of Change, Cost Savings, and New ... Product Introductions at various domestic and international manufacturing facilities. Manage projects with moderate complexity and scope and be required to effectively manage multiple projects with minimal assistance and supervision. May work on a large-scale… more
- GE HealthCare (Waukesha, WI)
- Job Description Summary The Senior Reliability engineer will be an integral part of the central DFR (Design for Reliability) program team within the STO org ... reliability plans -especially around new product designs Provide troubleshooting and CAPA expertise/assistance for unusual or persistent product problems thru the… more
- LanceSoft (Lafayette, CO)
- Must Have: CAPA Medical Device Risk Management RPM Quality Nice to Have: 10+ Years design experience in medical device industry, Class III experience helpful, but ... experience Experience in Complaint Handling, Regulatory Reporting, FCA, FDA, and/or CAPA PMP Certification or other formal Project Management training and experience… more
- LanceSoft (North Haven, CT)
- …to include specifications, procedures, sampling methods, tolerance studies and GD&T * CAPA , Root Cause investigations quality tools to include DMAIC A3, 5 ... recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of… more
- Northwoodspace (Los Angeles, CA)
- …with real impact, we want you at Northwood. Role: Northwood is seeking a Senior Supplier Development Engineer to be the first quality-focused hire. This role ... supplier quality issues through root cause analysis and corrective/preventive action (NCR/ CAPA ) Support the development of incoming inspection plans and testing… more
- GE HealthCare (Waukesha, WI)
- …electrical technologies to drive supply chain excellence. The role reports to the Sr . Director, Supplier Quality & Development Engineering, based in the US and ... suppliers. Lead Root Cause Investigations and Corrective and Preventive Action ( CAPA ) activities at assigned suppliers within the established procedures of the… more
- Granules Pharmaceuticals (Chantilly, VA)
- Job Type Full-time Description As a Sr . Mechanical Engineer (Chantilly, VA) for Granules Pharmaceuticals Inc, the job duties include but not limited to: Oversee, ... plus 3 years experience in job offered or as Sr . Technical Service Engineer . As an alternative...is acceptable. Require skills and working knowledge of IQ/OQ/PQ, CAPA , API, PLC, FDA regulations, cGMP/ SOPs. Job Location… more
- Nevados (Oakland, CA)
- …to manage their time effectively. Reporting to the Director of Quality, the Nevados Sr . Supplier Quality Engineer will be responsible for ensuring the highest ... quality issues, identify root causes, and implement corrective and preventive actions ( CAPA ) to prevent recurrence. Support the NPI processes related to supplier… more
- Michael Page (Waterbury, CT)
- …partnered up with a growing Plastics Manufacturing Company in their search to add a Senior Quality Engineer to the team due to growth. This position will report ... If interested, please read on and apply to the Senior Quality Engineer - Plastics based near...(DFM/DQA) Conduct root cause analysis and drive corrective/preventive action ( CAPA ) for internal and customer issues Oversee statistical process… more
- Diamond Antenna and Microwave (Littleton, MA)
- …Type Full-time Description Position Summary: We are seeking a highly experienced Senior Manufacturing Engineer with specialized expertise in the production of ... wear/lubrication failures. Lead root cause analysis (RCA) and corrective/preventive actions ( CAPA ) for internal and field quality issues. Support cleanroom and… more
- Plexus Corp. (Neenah, WI)
- …skill level. Salary Range: $75,400.00 - $113,000.00 Purpose Statement: The Quality Engineer Sr ensures products comply with customer specifications, industry ... Management System (QMS) audits. Lead product-related Corrective and Preventive Action ( CAPA ) discussion and closure. Key Job Accountabilities: Serve as the primary… more
- Boston Scientific (St. Paul, MN)
- Recruiter: Spencer Gregory Hale Quality Engineer - Electrical About this role: This Quality Engineer role offers an employee the opportunity to be part of the ... to identify performance improvement opportunities. May include NCEP & CAPA ownership. Mentoring product investigators by providing technical guidance in… more
- New York Technology Partners (Iselin, NJ)
- …internal procedures. Develop and implement corrective/preventative action plans, internal CAPA 's and supplier SCARs Provide verification and validation, sampling, ... and ISO 13485 requirements and defining and managing preventive actions plans for internal CAPA and Supplier SCAR and experience in CMM, PFMA, and DHR reviews and… more
- Actalent (Elwood, KS)
- Validation Engineer The Validation Engineer will play a crucial role in commissioning and qualification efforts for equipment, utilities, and processes. This ... CQV strategy. Support quality systems such as change control, deviations, CAPA , audits, quality metrics, and annual product reviews. Essential Skills Proven… more
- Bristol-Myers Squibb Company (Devens, MA)
- …Quality Assurance role is stationed in Devens, MA and reports to the Senior Manager, Field Quality Assurance for the Devens CTF. Key Responsibilities Provide ... BMS quality management system including but not limited to deviation and CAPA action management, interim production controls, disposition decisions, and batch record… more
- Fresenius Medical Center (Waltham, MA)
- …Availability to work different time zones as per business need. **PURPOSE AND SCOPE:** The Senior Engineer , CAPA is responsible for coaching CAPA ... **ADDENDUM:** **_GMS CAPA Office Focus_** + Responsible for development of...necessary requirements from FME Quality Management and formerly used NC/ CAPA tools into one global electronic NC/ CAPA … more
- Fresenius Medical Center (Waltham, MA)
- **PURPOSE AND SCOPE:** The CAPA Quality Engineers are assigned Corrective Action and Preventive Action ( CAPA ) investigations as well as Non-Conformance (NC) ... DUTIES AND RESPONSIBILITIES:** + Utilizes Quality System to ensure CAPA system is successful and compliant. Partners with Quality...as directed by immediate supervisor. + May refer to senior level staff for assistance with higher level problems… more
- Abbott (Alameda, CA)
- …to be onsite Mon-Fri. The position will be responsible for driving CAPA projects through its entire life cycle, mentor lower-level engineers, while strategizing ... continuous process improvements that aid in improving the CAPA program. **What You'll Work On** + Lead, mentor...issues. + Accountable for leadership and oversight of the CAPA system, and associated deliverables. + Provide guidance, insight… more
