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Senior QA Engineer

Company: BD Infusion Therapy Systems, Inc
Location: Sandy
Posted on: May 3, 2021

Job Description:

Job Description SummaryJob DescriptionSenior QA EngineerAs directed by the Associate Quality Manager, the Senior QA Engineer is accountable for Quality Assurance in the Surgical Scrub manufacturing area by developing and maintaining quality control plans, dealing with non-conforming material, customer complaints, remediation projects, CAPAs and providing quality metrics to manufacturing and quality management. This position assures the manufacturing areas are compliant to Pharmaceutical regulations, cGMP, and leads continuous improvement activities for improved quality and production. Primary Responsibilities Provides guidance and Quality oversight to ensure establishment and execution of robust design programs aligned with domestic and international regulatory requirements and industry standards.Extensive application of technical principles, theories, concepts and quality sciences, tools and systems with measurable / confirmed results.Track record of root cause determination and effective corrective and preventive action implementation.Provides training for operations and engineering teams on best practices.Subject matter expert on procedures and regulations during Audits.Writes and leads risk management activities.Analyze data and lead improvement projects.May perform other duties as required. Position Specific Overview Support the implementation of new products, processes, and changes by developing quality plans, approval of validation plans and protocols, inspection methods/plans, work instructions, and raw material specifications.Analyze and interpret inspection and process data to identify continuous improvement opportunities and prevent quality problems.Responsible for the investigation, documentation, root cause, and corrective action activities of deviations and non-conforming material.Responsible for the investigation, documentation, root cause, and corrective action activities of customer complaints.Support manufacturing and quality process improvement projects as an effective team member or leader using continuous improvement and six sigma tools.Develop working knowledge of applicable regulatory, corporate and unit requirements.Facilitate change control, as needed.Conduct internal audits as required. Provide audit support for customer and regulatory audits (preparation, closure, etc.).Communicate across functions and departments for assigned areas of responsibility.Support activities related to drug filing such as annual regulation review, as assigned.Analyze and verify the consistency of existing products through annual product review.Perform manufacturing investigations for out-of-specification / out-of-trend investigation for product release and stability testing. Minimum Education and Experience Requirements Required: Bachelor's degree in Engineering or a scientific discipline.Minimum of 3-5 years relevant experience or a combination of equivalent education and relevant experience.Extensive knowledge of Pharmaceutical regulatory requirements required.Leadership, project management, and advanced communication skills required.Pharmaceutical experience required.Automated high-volume manufacturing experience (preferred)Training in design of experiments and statistics (preferred)Knowledge of design control principles (preferred).Knowledge of six sigma methodology (preferred).ASQ certified quality engineer (CQE) (preferred).Compliance with all local, state, federal, and BD safety regulations, policies, and procedures including RCRA Hazardous waste pliance with all local BD quality policies, procedures, and practices through consistent application of sound quality assurance principlesPrimary Work LocationUSA UT - SandyAdditional LocationsWork Shift

Keywords: BD Infusion Therapy Systems, Inc, Sandy , Senior QA Engineer, Other , Sandy, Utah

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