Quality Engineer

POSITION SUMMARY

The Quality Engineer plays a vital role in ensuring the organization's ongoing compliance with established quality assurance standards for manufacturing and production. This position supports both initial compliance efforts and continuous monitoring, testing, and improvement of quality processes.

Key responsibilities include analyzing trends in internal controls, conduction risk assessments, and proactively identifying and evaluating potential deficiencies. The Quality Engineer collaborates closely with cross-functional teams to develop and implement effective solutions, ensuring robust corrective and preventive actions.

As a technical resource, the Quality Engineer participates in problem investigation, guiding root cause analysis and supporting the development of sustainable corrective actions. This role is responsible for investigating assigned CAPAs, complaints, and NCRs to root cause, driving timely and effective resolutions. Additionally, the Quality Engineer contributes to product improvement and manufacturing investigation, supporting a culture of continuous improvement and operational excellence.

POSITION RESPONSIBILITIES

• Develop and Document Test Methodologies: Design and document validation and verification for equipment, methods, material, and instrumentation. Determine appropriate sampling plans and measurements for reagent formulation production, monitoring performance and identifying potential emerging issues.
• Proactive Monitoring and Trending: Conduct ongoing monitoring and trending of quality and manufacturing data to proactively identify and address emerging issues. Promptly notify management of potential risks and contribute to continuous improvement initiatives.
• Collaboration: Engage in clear, professional communication with production teams to identify root causes and drive process improvements.
• ERP Transactions for Non-Conformances: Process ERP transactions to segregate and disposition non-conforming product, ensuring proper documentation and traceability..
• Procedure and Process Improvement: Assist with developing, reviewing and improving procedures and processes related to product quality.
• Audit support: Participate in internal and external audits, supporting audit readiness and compliance.
• Additional Quality Duties: Perform other responsibilities within the Quality Department as assigned, contributing to the overall success of the team.
• Non-Conformance Reporting (NCR): Monitor NCRs for trends, proactively address quality issues, and escalate to CAPA as necessary.
• Material Review Board (MRB) Participation: Support and participate in MRB for product review, control and disposition
• Incoming QC Specifications: Develop and / or improve incoming QC specifications (inspection criteria and sampling plans). Collaborate with QC Technicians to maintain efficient material flow for production needs.
• Validation Program Participation: Actively participate in the Validation Program, including review and approve validation protocols and reports. Ensure robust equipment qualifications, and product and process validations. Support to validation teams to achieve project milestones. Support to validation teams for documenting process risk analyses. Serve as in-house expert for Process Validation, equipment qualification, and process risk analysis (pFMEA).
• Product Development Support: Represent QA in product development activities, including design reviews and risk management. Review and approve Design History File (DHF) documents, ensuring compliance to design control requirements.

EDUCATION & EXPERIENCE

• Bachelor's degree required, preferably in science, engineering, or veterinary fields. Advanced degrees (MS) in Science or Engineering are a plus.
• A minimum of three years' experience in an FDA-regulated environment within the medical device or in-vitro diagnostics industry preferred.
• Demonstrated knowledge or hands-on experience in ISO9001, ISO13485, ISO14971 standards
• ASQ CQE / CQA certification preferred.
• Lyophilization experience is a plus.

TECHNICAL SKILLS

• Strong attention to details and ability to understand and follow complex procedures.
• Strong technical skills including statistical techniques.
• Proficient in basic computer applications such as Microsoft Word, Excel and Outlook.
• Effective and clear written and verbal communication skills.
• Strong decision making skills and ability to meet project timelines
• Analytical and data-driven approach to problem-solving, applying experimental methods and learning from both success and failures to drive improvement.
• Exhibits strong self-awareness and is open to feedback.
• Makes sound and timely decisions on an informed basis, in good faith in the best interest of the company.

Physical Requirements

Union City, CA site based position

The US base salary range for this full-time position is $77,000 - $118,000. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the base pay target range for new hire salaries for the position. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training.

This position is also eligible for short-term incentive compensation.

In addition to compensation, Zoetis offers a comprehensive benefits package that supports the physical, emotional and financial wellbeing of our colleagues and their families includinghealthcare and insurance benefits beginning on day one, a 401K plan with a match and profit-sharing contribution from Zoetis, and 4 weeks of vacation.

Visit zoetisbenefits.com to learn more.

Full time

Regular

Colleague

Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.

Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.

Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at zoetiscolleagueservices@zoetis.com to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at www.Zoetis.com/careers site, or (2) via email to/from addresses using only the Zoetis domain of "@zoetis.com". In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.