Senior Quality Engineer

Job Description

Job Description

Actalent is hiring for a Sr Quality Engineer in the Hayward area!

Job Description

This role provides comprehensive Quality Engineering support for one or more product lines at a manufacturing facility in Hayward, CA. The Sr Quality Engineer supports operations from raw materials through finished medical devices, maintains and improves the Risk Management process and documentation, and collaborates closely with product design and vigilance teams to address quality issues and drive continuous improvement. The position sustains production processes in a state of control and compliance by planning, executing, and implementing process validation and controls that meet regulatory requirements, internal standards, and current industry practices. The Sr Quality Engineer authors and reviews validation processes and procedures, recommends improvements, and may focus on equipment, process, or control system validation, or a combination of these areas.

Responsibilities

• Evaluate operational data, reports, statistics, and documentation related to manufacturing processes and product performance in the field to identify trends and generate proactive, timely actions that reduce complaints and improve performance metrics.
• Assure product compliance to specifications by implementing effective inspection criteria and procedures within operations processes, and drive quality and manufacturing improvements to keep processes in a stable state of control.
• Develop and analyze statistical data and product specifications to ensure consistent product quality and compliance with requirements.
• Apply standard operating practices and structured problemsolving methodologies to investigate and resolve quality and process issues.
• Perform root cause investigations for negative trends, process or product failures, and unmet critical characteristics, and prepare clear, comprehensive reports of findings and corrective actions.
• Document investigations and actions within the quality system using appropriate mechanisms such as Nonconformance Reports (NCR) and Corrective and Preventive Actions (CAPA).
• Organize, review, and perform computer system validation and other software validation evaluations to support the Master Validation Plan.
• Support data integrity initiatives for relevant systems, processes, and equipment, ensuring that data is accurate, complete, and reliable.
• Develop and maintain Risk Management documentation, including software risk assessments, for all product families and software defects.
• Plan and perform validation activities, including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Test Method Validation (TMV), as assigned.
• Partner with Project Engineering and Manufacturing Engineering teams to ensure smooth transition of new projects and software changes into daytoday operations.
• Evaluate and perform computer system validation for applicable software and GxP computerized systems in alignment with internal standards and regulatory expectations.
• Analyze and assess software change controls for their impact on computer system validation, data integrity, hardware interactions, and cybersecurity.
• Provide coaching and mentoring to colleagues and stakeholders on computer system validation (CSV), Software Development Life Cycle (SDLC), data integrity, and cybersecurity standards, regulations, guidance, and best practices.
• Update procedures and modify processes to simplify complexity, improve efficiency, and enhance overall process robustness.
• Perform other related duties as assigned to support the quality organization and manufacturing operations.

Essential Skills

• Demonstrated experience in process validation for medical devices, including planning, execution, and documentation of validation activities.
• Demonstrated experience in risk management for medical devices, including development and maintenance of Risk Management documentation.
• Engineering depth and strong ability to understand product and process operating principles, control points, methods, and the interactions between design and process, as well as their impact on end users.
• Proficiency with Good Documentation Practices (GDP) and current Good Documentation Practices (cGDP), with the ability to produce clear, accurate, and compliant documentation.
• Strong verbal and written communication skills, with the ability to convey complex technical information clearly to diverse audiences.
• Strong interpersonal skills and the ability to collaborate effectively with crossfunctional teams, including manufacturing, engineering, design, and vigilance functions.
• Selfmotivation and the ability to work independently while managing multiple tasks and priorities in a dynamic environment.
• Ability to update procedures and modify processes to simplify complexity and improve operational efficiencies.
• Minimum of a BA or BS degree in Engineering with at least 3 to 5 years of related experience in Quality Engineering or equivalent demonstrated performance.
• Understanding and application of structured problemsolving methodologies and root cause analysis techniques.
• Experience with computer system validation (CSV) and software validation in a regulated environment.
• Familiarity with GxP computerized systems and related regulatory expectations.

Additional Skills & Qualifications

• A Masters degree in Engineering or Business Administration may be used in lieu of 2 years of related experience.
• Lean or Six Sigma Green Belt or higher certification is preferred and supports continuous improvement initiatives.
• Experience developing and maintaining Risk Management documentation, including software risk assessments for multiple product families.
• Knowledge of Software Development Life Cycle (SDLC) principles and their application in validated systems.
• Experience supporting data integrity initiatives for systems, processes, and equipment in a regulated environment.
• Exposure to cybersecurity considerations related to software, hardware interactions, and GxP systems.
• Experience authoring and reviewing validation processes and procedures, including recommendations for improvements.
• Experience mentoring or coaching others on CSV, SDLC, data integrity, and cybersecurity best practices.

Work Environment

This is a fulltime, onsite position based in Hayward, CA, with a standard schedule of Monday through Friday, 8:00 a.m. to 5:00 p.m. The role operates within a regulated manufacturing environment that produces medical devices, involving close collaboration with manufacturing operations, engineering, design, and quality teams. The work environment includes office settings for documentation and data analysis as well as production areas where process validation, inspections, and system evaluations occur. Employees follow sitespecific safety and compliance procedures appropriate for a medical device manufacturing facility.

This is a Contract position based out of Hayward, CA.

The pay range for this position is $55.00 - $60.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Hayward,CA.

This position is anticipated to close on Oct 9, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email View email address on ziprecruiter.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.