Job Description - Quality Engineer II in West Valley
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Quality Engineer II

Ref: US_EN_6_971649_1479316

Posted on 06 January 2023

Quality Engineer

Generates Risk Management Files (pFEMA) to new ISO 14971 standard. Helps execute Validation of equipment and Processes (test method validation.) Monitors, inspects, and evaluates products to ensure predetermined quality standards are met. Develops and updates testing-related documentation, including test cases, plans, and flaw-reporting procedures.

Bachelor's Degree is required.

4-6 years of experience.

Responsibilities: Recommend process/quality improvements as part of validation runs. Evaluate, investigate and document non-conformances incidents and/or protocol deviations. Complete assigned Non-Conformance and CAPA investigations and prepare investigation reports. Develops and maintains an effective cross-functional working relationship with plant and corporate Manufacturing, Engineering, Regulatory, Design Assurance, Product Development and Quality Assurance personnel. Work on project teams with other internal departments, external vendors, and customers as required. Assure that existing processes and assigned activities fully comply with regulatory and/or international agencies, such as FDA, ISO, OSHA, EPA, among others. Participate in the compilation and review of technical documentation for both domestic and international regulatory submissions. Participate in external audits such as: FDA, Notified Body (BSI) and Corporate, among others. Performs other related duties as necessary.

Qualifications: Knowledge of FDA, OSHA, EPA, and GMP's and ISO requirements. Knowledge in Organizational Excellence and Lean/Six Sigma. Strong Project Management skills. Ability to lead teams through complex projects and provide departmental technical leadership. Must have excellent communication skills and a strong track record of working cross-functionally. Must have demonstrated ability to think strategically. Able to develop technical documentation such as: Risk Management Files, Change Controls, Validation Plans, Validation Protocols, Technical / investigation reports, SOP, and others. Teamwork oriented and self-starter.

Education and/or experience:

BS in Engineering, preferably Mechanical, Manufacturing, Industrial, Electrical, Chemical, or Biomedical (Professional Engineer License.) or sciences related field.

Lean/Six Sigma Green or Black Belt Certification is a plus.

Minimum of 4-6 years of experience in the medical device and/or pharmaceutical manufacturing environment.

Equal Opportunity Employer/Veterans/Disabled

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