Senior Quality Engineer

Job Title: Senior Quality Engineer

Location: Hayward, CA

Duration: 12 Months

Position Summary:

• The Senior Quality Engineer will provide Quality Engineering support for one or more medical device product lines. This role will support manufacturing operations from raw materials through finished devices, maintain risk management activities and documentation, and partner closely with Product Design, Manufacturing Engineering, and other cross-functional teams to resolve quality issues and drive continuous improvement.
• The position will support production processes in a state of control and compliance through process validation, process controls, risk management, and quality system activities. The engineer may focus on equipment, process, software, or control system validation, or a combination of these areas.

Key Responsibilities:

• Evaluate manufacturing and product performance data, reports, trends, and documentation to identify proactive quality improvement opportunities.
• Ensure product compliance with specifications through effective inspection criteria, process controls, and quality procedures.
• Develop and analyze statistical data to monitor and improve product and process quality.
• Apply structured problem-solving methodologies to address manufacturing and product quality issues.
• Lead root cause investigations for process or product failures, adverse trends, and critical characteristic issues.
• Document investigations and corrective actions through quality system processes, including NCR and CAPA.
• Develop, maintain, and execute Risk Management documentation for assigned product families and software-related risks.
• Plan and execute validation activities, including DQ, IQ, OQ, PQ, and TMV.
• Support process validation and ensure manufacturing processes remain compliant with applicable regulatory and quality requirements.
• Author, review, and update validation protocols, reports, procedures, and related documentation.
• Support Computer System Validation (CSV) and software validation activities for applicable computerized systems.
• Support data integrity initiatives related to systems, processes, equipment, and manufacturing operations.
• Evaluate software change controls, including impacts related to validation, data integrity, hardware interfaces, and cybersecurity.
• Collaborate with Project Engineering and Manufacturing Engineering to transition new products, processes, equipment, and software changes into production.
• Provide technical guidance and mentoring on CSV, SDLC, data integrity, cybersecurity, validation, and applicable regulatory requirements.
• Identify opportunities to simplify processes, improve efficiency, and strengthen quality and operational controls.
• Perform other related duties as assigned.

Required Qualifications:

• 3 5+ years of relevant Quality Engineering experience, preferably within the medical device industry.
• Demonstrated experience with process validation and risk management in a regulated medical device environment.
• Strong understanding of product and process operating principles, process controls, critical characteristics, and design/process interactions.
• Experience with validation methodologies such as DQ, IQ, OQ, PQ, and TMV.
• Experience with quality investigations, root cause analysis, NCR, CAPA, and continuous improvement.
• Strong analytical and statistical problem-solving skills.
• Excellent written and verbal communication skills.
• Strong technical documentation and cGDP practices.
• Ability to review, revise, and improve procedures and processes to increase efficiency and reduce complexity.
• Strong cross-functional collaboration and interpersonal skills.

Education:

• Bachelor's degree in Engineering or a related technical discipline with 3 5+ years of relevant experience.
• A Master's degree may substitute for up to two years of relevant experience.
• Engineering or Business Administration background is preferred.
• Lean or Six Sigma Green Belt or higher is preferred.
• Physical Demands & Work Environment

Benefits:

Eligible employees may have access to benefits offered by Intellectt Inc. in accordance with the applicable benefit plans and eligibility requirements.

Equal Employment Opportunity:

Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.