Quality Engineering Manager

POSITION SUMMARY
- Leads and participates in continuous improvement activities across business areas, focusing on instrumentation, chemistry, software, and testing.
- Directs and prioritizes tasks to ensure timely and accurate completion of tests and records.

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.
- Generate, implement, and review Standard Operating Procedures (SOPs) and Standard Methods.
- Ensure testing is properly documented and conducted per written protocols.
- Oversee training and competency of PSG technicians.

Product and Process Improvement
- Analyze data to identify product improvement opportunities.
- 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 summary reports).
- Assist in failure analysis of returned materials, components, and subassemblies.
- Initiate actions to enhance product robustness and reliability.
- Support manufacturing process improvement initiatives.
- Establish/refine process limits and develop inspection and test methods for production.

Quality Assurance and Risk Management
- Implement and maintain a quality risk management process across the product lifecycle.
- Ensure operational excellence tools are used in quality procedures/processes.
- Provide QA support to validation activities (facilities, equipment, utilities, cleaning, process validation).
- Prepare and maintain the site Validation Master Plan.
- Oversee qualification protocols and reports.
- Review and approve process-related change controls and change plans.
- Identify and communicate potential compliance gaps/risks to management.
- Support inspection readiness and regulatory site inspections.

Continuous Improvement
- Drive Lean-based continuous improvement to enhance cycle time, productivity, efficiency, and quality.
- Provide quality guidance and facilitate timely resolution of quality issues.

Staffing and Leadership Responsibilities
- Foster leadership development and coaching; create a learning organization.
- Ensure training and development plans are established for QA associates.
- Develop budgets and resource plans for the Site Quality Budget.
- Support development of quality goals and targets.

QUALIFICATIONS & REQUIRED/ PREFERRED SKILLS
Education & Experience
- Bachelor’s degree in engineering or a scientific discipline, or equivalent relevant experience.
- 5–10 years in Quality Engineering in a regulated manufacturing environment (preferably medical devices).
- Minimum 3 years of leadership experience (preferred).

Required Technical Skills & Competencies
- Knowledge of ISO 13485 and FDA 21 CFR 820; ability to ensure compliance with changing guidelines.
- Ability to troubleshoot problems and implement corrective action.
- Strong written and oral communication skills.
- Understanding of equipment used by technicians.
- Analytical, data-driven problem-solving skills.
- Experience with software programs including Excel, PowerPoint, Word, Minitab, or JMP.
- Statistical techniques, reliability test methods, electro-mechanical aptitude, and software programming.
- Strong attention to detail.
- Apply an analytical/experimental mindset to learn from successes and failures.
- Self-awareness and openness to feedback.

Physical Requirements
- Ability to stand, bend, squat, and lift up to 25–30 lbs.
- Use required PPE.
- Onsite presence required in Union City, CA.
- Must remain drug-free; drug screening completed prior to starting.