Sr. Quality Engineer

Company: Teleflex
Location: Pleasanton
Posted on: May 3, 2021

Job Description:

Position Summary

The Senior Quality Engineer will be responsible for all aspects of Quality Engineering including the development, documentation, implementation and maintenance of quality requirements and procedures related to production, manufacturing, and operations activities. This individual will provide Quality Engineering representation, support, guidance and participation to internal functions (primarily Manufacturing /Operations) in supporting existing products, new product introductions, and participating in various project teams. In this position, this individual will be working in partnership with Manufacturing/Operations in the development, validation/qualification, transfer, production and maintenance of the company's products into manufacturing.

• Serve as subject matter expert in quality engineering to Manufacturing/Operations in supporting manufacturing activities/projects/initiatives (including process validations, equipment qualifications, master validation plans, product quality plans, device history records, in-process quality monitoring, manufacturing scale-up activities, and environmental monitoring).
• Partner with Manufacturing/Operations to establish quality requirements across the manufacturing process including incoming, in-process and final product inspection and monitoring requirements.
• Provide quality guidance and participate in conducting risk management activities including, hazard identification, hazard analysis, failure mode effects and analysis, and risk mitigation.
• Support theassembly, control, approval and maintenance of various Quality records.
• Review and analyze production/manufacturing data to determine the primary factors affecting product quality, yield, throughput, cost, and drive continuous improvement initiative with both internal and external operations as necessary.
• Provide technical guidance to QC technicians with regards to inspections activities and drive activities to improve product quality, decrease costs, optimize inspection requirements and increase overall efficiency.
• Support the non-conforming material process and participate in MRB meetings/discussions to address and resolve non-conformances related to products and/or processes.
• Support CAPA activities and work in conjunction with CAPA owners in conducting investigations, root cause analysis/determination, action plans and effective checks for the effective and timely completion of CAPAs.
• Support product complaint investigation activities and participate in returned product examinations/investigations as necessary.
• Develop quality assurance specifications, test methods, sampling plans and related written procedures.
• Participate in the creation, review, approval and disposition of engineering change requests involving product or process changes.
• Employ proactive, systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving quality issues.
• Drive the use of Quality Engineering methodologies, tools, statistical techniques, etc. to assist in the resolution of day-to-day quality issues.
• Foster the importance of quality and regulatory requirements (not just the what but also the why) and build cross functional advocates for quality within the functions supported
• Build and maintain effective cross-functional relationships with internal departments such as Operations/Manufacturing, R&D/Engineering, Quality Control, and Regulatory Affairs.
• Serve as subject matter expert for areas of responsibilities during external audit activities from various government agencies and private companies & consultants (such as CA FDB, US FDA, NSAI, etc.).
• Work in accordance with and ensure compliance with the quality system procedures related to areas of responsibility.
• Lead department specific initiatives and projects as assigned.
• Perform other duties as assigned by Quality Management.
• Education / Experience Requirements
• Bachelor of Science in Engineering, Technical or Life Science discipline.
• Minimum of 8 years overall experience in Quality Engineering.
• Minimum of 5 years hand-on experience in ISO13485, MDD, and FDA QSR compliant Quality Systems with a medical device manufacturing company.
• Experience with Class II and/or III sterile devices (preferred).
• Hand-on experience in the use and application of statistical techniques in a product development and manufacturing capacity.
• Experience with nitinol material processing, metal fabricated components, and plastic injection molded components.
  
• Specialized Skills / Other Requirements
• ASQ Certified Quality Engineer (desirable / preferred).
• ASQ Certified Quality Auditor (desired / preferred).
• Strong written, oral, and interpersonal skills.
• Strong analytical skills, problem solving techniques and statistical application experience.
• Knowledge in the areas of Manufacturing Process Validation, high-volume manufacturing practices/principles, and statistical techniques.
  
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Keywords: Teleflex, Pleasanton , Sr. Quality Engineer, Other , Pleasanton, California