- Merck & Co. (Rahway, NJ)
- …expertise and knowledge of product and process development in the (bio)pharmaceutical and medical device industries to set tactical and strategic direction on ... product launch. The ideal candidate will possess extensive knowledge in medical device engineering, particularly in the design, manufacturing, verification,… more
- Merck & Co. (Rahway, NJ)
- …injection.-- Job descriptionThis position will be responsible for leading and implementing medical device and combination product design controls for both new ... position will interact with cross-functional development teams within and external to Device Development. The incumbent must...plus 10 years of related experienceHas broad knowledge of medical device development, design controls and risk… more
- Resolution Medical (Minneapolis, MN)
- …for the successful planning, management and execution of complex, usually multi- device product development projects and all applicable standard operating procedures. ... Manager will lead a cross-functional team consisting of product development, quality , manufacturing, and procurement personnel, through the Product Development cycle… more
- Nesco Resource (Dublin, OH)
- …be familiar with and comfortable using computers. *Working knowledge of the medical device regulatory procedures, lean manufacturing, and manufacturing processes ... The Assembler I position will inspect, weigh, package, and sort out defective medical devices as required. Essential Duties & Responsibilities *Keep work area clean.… more
- Merck & Co. (Durham, NC)
- …Experience and Skills: Manufacturing - Injection Molding and Automated Assembly of Medical Device Components. Final Assembly and Packaging of Combination ... and compliance requirements governing development and manufacturing for MDCP (21 CFR Part 4, Medical Device Reporting, ISO 13485:2016, EU Medical Device … more
- Amazon (Sunnyvale, CA)
- …contributing to architecture, implementation, and long-term maintainability Write high- quality , well-tested code that meets production standards Participate in ... high-impact features Investigate and resolve complex issues across the device -mobile-cloud stack Contribute to continuous improvement of team processes, tools,… more
- Medtronic (Boston, MA)
- …aspects of the Surgical Operating Unit's (SOU) Post-Market Risk Management of medical device products or software systems. *May develop, evaluate, implement ... A Day in the Life of a Post-Market Risk, Quality Engineering Manager - reporting to Director of Post-Market...SPECIALIZED SKILLS OR EXPERIENCE *Risk Management experience in the medical device industry *Risk Management File lifecycle… 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 not required Kaizen Lean Six Sigma Certified Medical device industry experience Experience in Complaint Handling, Regulatory Reporting, FCA, FDA,… more
- Natus Medical (Middleton, WI)
- …test software language/platform Knowledge of regulatory requirements in medical device industry Experience in FDA Quality System Regulations, Current Good ... the maintenance and sustainment of the entire Natus' Neuro medical device portfolio. This engineer will be...Manufacturing Practices, risk management (ISO 14971], and Quality Management Systems for Medical Devices [ISO… more
- Integra LifeSciences (Plainsboro, NJ)
- …Mechanical, Chemical, or Electrical) Experience: 3 to 6 years of experience in a Quality Assurance role for medical device or pharmaceutical manufacturing. ... corporate policies, US Food and Drug Administration regulations, ISO 9001, ISO 13485, the Medical Device Directive, the Canadian Medical Device … more
- Abbott (Pleasanton, CA)
- …Systems, Quality Assurance and/or Regulatory Compliance/Affairs experience in medical device manufacturing or other similarly regulated environment. ... driving cross-site audit support and audit readiness initiatives to improve quality systems, and overall organizational compliance to internal/ external … more
- Otsuka Pharmaceutical Co., Ltd. (Princeton, NJ)
- …experience of working in the global pharmaceutical and medical device industry. Experience working with external service providers. Working knowledge ... an experienced and dynamic Executive Director of R&D Global Quality to join our team. This pivotal role will...years of experience in a FDA regulated pharmaceutical and/or medical device industry environment Strong knowledge of… more
- Actalent (Knoxville, TN)
- …conclusions. Essential Qualifications: *Previous Quality Engineering experience in the Medical Device manufacturing industry in compliance with 21 CFR 820, ... Description KEY PURPOSE OF ROLE Quality Engineer will support all quality ...execute continuous improvement initiatives using Lean Six Sigma principles * Medical Device Regulations Knowledge; FDA 21 CFR… more
- Manufacturing Inc (Putnam, CT)
- …the job Quality Inspector Join our team as a Quality Inspector and Quality Technician in the medical device industry and become part of a company ... existing products. Assist in the calibration and maintenance of quality control equipment. Participate in internal and external...Previous experience as a Quality Inspector or Quality Technician in the medical device… more
- Ortho Clinical Diagnostics (Rochester, NY)
- …for all. The Role As the company continues to grow, we are seeking a Quality Technician III for Device History Record (DHR) review and Incoming Inspection. This ... for visa sponsorship. The Key Working Relationships Internal Partners: Quality , Product Support, PP&L/Materials Management, Operations External : Suppliers… more
- Terumo BCT, Inc. (Littleton, CO)
- …complex technical investigations, this position is ideal for professionals with experience in medical device quality systems. If you're passionate about ... the world. For Terumo, for Everyone, Everywhere. We make medical devices and related products that are used to...Quality System. Provides support to the internal and external audit program. Leads and participates in continuous improvement.… more
- Ascential Technologies (San Diego, CA)
- Ascential Medical and Life Sciences is a leader in delivering precision engineering and automation solutions for medical devices, diagnostics, and life sciences. ... We are looking for a Supervisor, Quality Control to join our multidisciplinary team, contributing to...number issuances and traceability. Review and approve inspection records, Device History Records (DHRs), and related QC documentation for… more
- Merck & Co. (Rahway, NJ)
- …robust scientific methodology we collaborate to discover and develop the next medical breakthrough. Our Company's success is backed by ethical integrity, forward ... (PSCS) deliverable which is the development of robust compositions, processes and device / packaging that enable patient centric products for patients. The successful… more
- Michael Page (Waterbury, CT)
- …or Six Sigma certification Experience with IQ/OQ/PQ validation protocols (especially for medical device or highly regulated industries) Familiarity with ERP and ... Manufacturing Company in their search to add a Senior Quality Engineer to the team due to growth. This...(MRB) meetings as needed Lead internal audits and support external audits (eg, ISO, customer audits) Participate in or… more
- Abbott (Buffalo Grove, IL)
- …in Medical Device industry Minimum of 4-6 yrs of experience in a Quality role in Medical Device industry Substantial knowledge of FDA and ISO ... manufacturing including yield and quality data reports, finished device acceptance, validation, external inspections, incoming, equipment calibration and… more
