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The primary objectives of the Sr. Quality Engineer are to review RCE’s to assure adequate funding to address GMP and potential product hazards contribute to development of appropriate process designs and validation protocols, assist in execution of validation protocols, support initial start-up production after engineering changes and/ or after producing new products and perform product assurance reviews and identify key quality issues and assure their resolution.
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Support on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects. Support manufacturing process development & qualification for new product commercialization and product changes.
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Provide backup assistance in development and execution of New Product Introduction (NPI) activities including tracking and trending and communication of NPI needs and/or trends to the leadership and support staff as appropriate.
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Establish effective team oversight of new product development to ensure post-market surveillance capabilities at time of launch. As the Manager Product Quality Engineering, Complaints you will be responsible for the group initiating and owning investigations associated with trends and emerging issues associated with product complaints, captured in the CAPA system.
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Minimum of 5 years of experience in medical device Quality Engineering, Research & Development, or Process / Manufacturing Engineering with experience supporting product development.
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This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support.
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Collects and analyzes Lead Manufacturing process defect data Product/Process improvement efforts (e.g. scrap, nonconforming product, customer complaints) by systematically gathering quality metric data and performing the appropriate analysis method(s) to enhance sustaining product design and new product development.
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Mechanical Development Quality Engineer I assures new or modified products conform to quality standards and establishes compliance with the quality system. Lead or support Risk Management activities from product Concept through Commercialization.
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Quality Engineer I is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support.
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This role will provide oversight and management for the software (digital and embedded) and technical quality organization, ensuring that the quality system requirements for design, validation and qualification for product development and production are effectively established and maintained to meet regulatory requirements.
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What You’ll Work OnThe Quality Assurance Specialist identifies all batch nonconformancesfor final audit/review and initiates appropriate actions for those non-conformances when needed, and issues Finished Product shipping releases in a timely manner for all conforming material goods.
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What you'll work on:The primary objectives of the Sr. Quality Engineer are to review RCE’s to assure adequate funding to address GMP and potential product hazards contribute to development of appropriate process designs and validation protocols, assist in execution of validation protocols, support initial start-up production after engineering changes and/ or after producing new products and perform product assurance reviews and identify key quality issues and assure their resolution.
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Provide Process/Quality Engineering support to product development teams, helping to ensure development of highest quality new products at the Scarborough Site. Develops and implements product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analyses, FMEAs in conjunction with other product development team members.
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You’ll also have access to:Career development with an international company where you can grow the career you dream of. Support design test and inspection method development, and lead method validation activities.
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Work with cross functional teams to ensure quality and compliance requirements are considered during activities (e.g., work with microbiology to ensure appropriate environmental monitoring and that microbiology require ments are considered in product and process development activities.
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product development jobs Title: quality Company: Abbott Laboratories
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