Quality Systems Engineer

Job Description

Quality Systems Engineer

Westpak, Inc. – San Jose, CA

Westpak exists to make lives better. From the products we test that are used by global consumers, to the people and communities we invest in, our purpose is to improve the lives of those around us. For over 35 years, Westpak has been a trusted testing partner for a diverse industry. Sustain that level of consistency requires a core ingredient, our great people. From the tenured employees who value the lasting bonds and share their wealth of knowledge, to our new employees who bring in new perspectives and opportunities; we continue to evolve our employee-owned company with stewardship and integrity while continuing to make lives better.

Westpak is looking for an experienced Quality Systems Engineer to support all Quality facets including Auditing, Validation, Compliance handling, and Corrective Action Request processing in a 17025 Accredited Lab environment. This role develops, prepares, presents, and implements solutions to issues and opportunities to help ensure the ongoing suitability and effectiveness of our Quality Management System (QMS).

We offer a competitive compensation package that includes ESOP shares, 401k match, Health Benefits, various Supplemental health packages, and pet insurance for your furry loved ones.

Essential Duties and Responsibilities (Other duties may be assigned as needed)

• 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.
  
  

Personal/Professional Attributes

• Strong business acumen and functional linkage for effectiveness
• High focus on customer service, and willing to go above and beyond to get the job done.
• Drives leadership and accountability
• Work collaboratively with colleagues
• Strong ethical composition
• Ability to find innovative solutions to complex problems.
• It is the responsibility of every Westpak employee to contribute to a positive work environment through cooperative and professional interactions with co-workers, customers, and vendors.
  
  

Requirements For Eligibility

• 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
• Knowledgeable of 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.
• Experience in supporting QMS Training programs.
• MS Word, Excel, PowerPoint proficient, MS Access or similar relational database proficiency is preferred.
• Direct experience managing or participating in an FDA and other agency audits a plus
  
  

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.

Currently anticipated salary range- $ 80- 100k annual base

Company Description

Westpak exists to make lives better. From the products we test that are used by global consumers, to the people and communities we invest in, our purpose is to improve the lives of those around us. For over 35 years, Westpak has been a trusted testing partner for a diverse industry. Sustaining that level of consistency requires a core ingredient, our great people. From the tenured employees who value the lasting bonds and share their wealth of knowledge, to our new employees who bring in new perspectives and opportunities; we continue to evolve our employee-owned company with stewardship and integrity while continuing to make lives better.

Westpak exists to make lives better. From the products we test that are used by global consumers, to the people and communities we invest in, our purpose is to improve the lives of those around us. For over 35 years, Westpak has been a trusted testing partner for a diverse industry. Sustaining that level of consistency requires a core ingredient, our great people. From the tenured employees who value the lasting bonds and share their wealth of knowledge, to our new employees who bring in new perspectives and opportunities; we continue to evolve our employee-owned company with stewardship and integrity while continuing to make lives better.