Quality systems manager Jobs in Fremont, CA

POSITION SUMMARY

The Quality Engineering Manager leads and participates in continuous improvement activities across all business areas, focusing on instrumentation, chemistry, software, and testing. The role is responsible for directing and prioritizing tasks to ensure timely and accurate completion of tests and records, supporting efficient product delivery.

This role reports into the Site Quality Lead.

POSITION RESPONSIBILITIES

Testing and Technical Oversight

• Manage the daily activities of workgroups and technicians, ensuring alignment with project goals.
• Lead problem-solving efforts for all aspects of testing, driving timely and effective solutions.
• Generate, Implement and review Standard Operating Procedures (SOPs) and Standard Methods.
• Ensure all testing is properly documented and conducted in accordance with written protocols.
• Oversee the training and competency of PSG technicians.

Product and Process Improvement

Analyze data to identify areas of product opportunities for improvement.

Design and execute experiments to expose and address product risks.

Support development of specialized test fixtures, software, and systems for required testing.

Analyze and report on product field performance, including issuing summary reports.

Assist in failure analysis of returned materials, components, and subassemblies.

Initiate actions to enhance product robustness and reliability.

Support the development and implementation or process improvements in manufacturing.

Establish and refine process limits, and develop appropriate inspection and test methods for production processes.

Quality Assurance and Risk Management

Implement and maintain a quality risk management process to monitor, control, and improve process performance and product quality throughout the product lifecycle.

Ensure the use of operational excellence tools in quality procedures and processes.

Provide Quality Assurance (QA) support to validation activities, including participation in project teams for facilities, equipment, utilities, cleaning, and process validation.

Prepare and maintain the site Validation Master Plan in compliance with current requirements.

Oversee qualification protocol and reports, providing quality oversight and assessment.

Review and approve process-related change controls and change plans.

Identify and communicate potential compliance gaps or risks to management.

Participate in inspection readiness and preparation activities, including support during regulatory site inspections.

Continuous Improvement

Drive continuous improvement initiatives to enhance cycle time, productivity, efficiency, and quality of work, utilizing Lean methodology.

Understand and support business needs, provide quality guidance, and facilitate timely resolution of quality issues.

Staffing and Leadership Responsibilities

Foster leadership development and coaching among staff, creating a learning organization.

Ensure training and development plans are established and implemented for all QA associates.

Develop budgets and resource plancs for integration into the Site Quality Budget.

Support the development of quality goals and targets as part of the organization's strategic plans

ORGANIZATIONAL RELATIONSHIPS

Colleague will interact with colleagues throughout the entire facility including working with Quality, Engineering, Operations, etc.

RESOURCES MANAGED

Direct Reports :

PSG Team

Quality Engineers

Software Engineer

EDUCATION & EXPERIENCE

B.S. in a science or technical area or 5-10 years' experience in a science related field.

TECHNICAL SKILLS & COMPETENCIES REQUIRED

Understanding of ISO 13485 & FDA 21CFR820. Ability to ensure compliance with changing guidelines.

Ability to trouble-shoot problems and implement corrective action.

Good written and oral communication skills.

Understanding of equipment used by technicians.

Analytical based problem solving skills

Experience with software programs including Excel, PowerPoint, Word, Minitab or JMP

Strict attention to detail is critical and required as well as effective written and oral communication skills

Use of statistical techniques, reliability test methods, electro-mechanical aptitude and software programming plus

Able to quickly analyze and solves problems by applying an analytical, data driven and experimental mindset and seeks to understand both successes and failures to improve and develop.

Exhibits strong self-awareness and is open to feedback

Physical Requirements :

Ability to physically stand, bend, squat, and lift up to 25 to 30 lbs.

Utilize required PPE.

The position requires onsite presence in Union City CA.

Must remain Drug-Free. (Drug screening completed prior to starting)

The US base salary range for this full-time position is $99,000 - $151,000 . 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. This position is also eligible for long-term incentives.

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.

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.