Sr. Quality Engineer
Posted on: May 3, 2021
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
- Partner with Manufacturing/Operations to establish quality
requirements across the manufacturing process including incoming,
in-process and final product inspection and monitoring
- Provide quality guidance and participate in conducting risk
management activities including, hazard identification, hazard
analysis, failure mode effects and analysis, and risk
- 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
- 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
- Employ proactive, systematic problem-solving methodologies in
identifying, prioritizing, communicating and resolving quality
- 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,
- Work in accordance with and ensure compliance with the quality
system procedures related to areas of responsibility.
- Lead department specific initiatives and projects as
- Perform other duties as assigned by Quality Management.
- Education / Experience
- Bachelor of Science in Engineering, Technical or Life Science
- Minimum of 8 years overall experience in Quality
- Minimum of 5 years hand-on experience in ISO13485, MDD, and FDA
QSR compliant Quality Systems with a medical device manufacturing
- Experience with Class II and/or III sterile devices
- Hand-on experience in the use and application of statistical
techniques in a product development and manufacturing
- Experience with nitinol material processing, metal fabricated
components, and plastic injection molded components.
- Specialized Skills / Other
- 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
Keywords: Teleflex, Pleasanton , Sr. Quality Engineer, Other , Pleasanton, California
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