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WESTPAK, Inc. ยท 4 days ago
Quality Systems Engineer
San Jose, CA
Full-time
Onsite
Mid Level
$80K/yr - $100K/yr
3+ years exp
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Responsibilities
Manage, support, and maintain assigned QMS subsystems, including CAPA/CAR & Nonconformances, Change Controls and training, etc.
Facilitate and drive effective problem-solving techniques that help resolve and prevent reoccurrence of QMS problems.
Develop, present, and deliver QMS training content/programs in the Quality Management System.
Recommend and implement enhancements to the quality system that result in improved corporate quality performance, increased customer satisfaction, and/or simplification of processes to reduce costs.
Manage and perform internal audits of assigned QMS elements to identify, present and report conformity to internal and external requirements (i.e., regulatory requirements, industry standards, corporate policies and operating procedures, methods and records).
Prepare and present clear audit reports which are supported by factual evidence of conditions found, meaningful conclusions and recommendations, and sound and unimpeachable judgment.
Manage and support the preparation and issuance of the annual internal audit schedule including related documentation in accordance with internal audit policies and procedures
Develop, present, release and maintain assigned quality system procedures which help to ensure compliance with QMS requirements and reduce/eliminate unnecessary operational burden.
Manage and prepare and present assigned Quality metrics in support of operational needs, management review, and any other quality driven data.
Some business travel might be occasionally required to support critical business needs.
The above statements are intended to describe the general nature and level of the work being performed by the employee assigned to this position. There are no exhaustive lists of all duties and responsibilities, knowledge, skills, abilities, physical job demands and working conditions associated with this position.
Qualification
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Required
Bachelor's degree (B.S.) in Packaging Technology, Quality, sciences or related field
Minimum of 3 years of experience operating in a testing lab (non-software) with a robust Quality Management System; experience with device environment preferred
Prior package testing and lab experience are required
Previous work experience in an ISO17025 environment is preferred
Experience with Verification and Validation techniques (IQ,OQ,PQ) and methods is a plus
Previous internal or supplier auditor preferred
Experience with specifying, collecting, analyzing, and presenting quality performance data
Experience in supporting QMS Training programs
Preferred
Experience with device environment preferred
Experience with structured problem-solving methodologies/techniques (i.e., Kepner-Tregoe, 8d, Shainin, 5 Why, DEMAIC, Kaizen, Lean Six Sigma) and quality tools (Cause and effect/Ishikawa-Fishbone, Control Charts, PDCA, Pareto Analysis, Check Sheet) is a plus
MS Word, Excel, PowerPoint proficient, MS Access or similar relational database proficiency is preferred
Direct experience managing or participating in FDA and other agency audits a plus
Benefits
ESOP shares
401k match
Health Benefits
Various Supplemental health packages
Pet insurance
Company
WESTPAK, Inc.
WESTPAK, Inc., a leading 3rd-party independent testing laboratory, provides trusted solutions for the medical device, pharmaceutical, and high-tech industries.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Nora Crivello
President and CEO
Company data provided by crunchbase
