Quality Engineer II

Quality EngineerWe are seeking a Quality Engineer to join a growing medical device contract manufacturing organization. This role is a key part of the Quality team, working closely with Engineering, Manufacturing, Operations, Suppliers, and Customers to ensure compliance, drive continuous improvement, and maintain a robust Quality Management System. The position is fully onsite with a 4x10 schedule from Monday to Thursday and is contract-to-hire. The ideal candidate is proactive, solutions-oriented, and comfortable taking ownership of complex quality issues from identification through resolution.Responsibilities:Maintain and improve Quality Management System (QMS) processes in accordance with FDA QMSR, ISO, and applicable regulatory requirements.Own and drive CAPA, nonconformance, complaint handling, and corrective action activities.Review quality trends and escalate recurring issues into formal quality investigations when appropriate.Support document control, procedure development, change controls, and engineering change activities.Serve as a quality representative during customer interactions related to complaints, investigations, and quality concerns.Partner with Engineering, Manufacturing, Operations, and Supply Chain teams to drive issue resolution.Plan, conduct, and support internal, supplier, customer, and regulatory audits.Manage supplier quality activities including supplier qualifications, monitoring, corrective actions, and audits.Lead quality training initiatives and educate employees on quality system requirements and best practices.Mentor junior quality personnel and develop organizational quality competencies.Utilize Excel, Power BI, and other reporting tools to analyze quality metrics and trends.Monitor performance indicators and identify opportunities for process improvement.Essential Skills:Bachelor's degree in Engineering, Quality, Life Sciences, or related technical discipline.Minimum 4+ years of Quality Engineering experience within a regulated medical device environment.Strong knowledge of FDA QMSR, ISO, CAPA Systems, Nonconformance Management, Complaint Handling, Change Control, Root Cause Analysis, and Quality Risk Management.Experience conducting or supporting internal, supplier, customer, and regulatory audits.Strong understanding of Quality Management Systems and electronic QMS platforms.Experience working cross-functionally with Engineering, Manufacturing, and Operations teams.Strong verbal and written communication skills.Ability to work independently and drive projects to completion with minimal supervision.Training and mentoring experience.Additional Skills & Qualifications:Medical device contract manufacturing experience.Supplier audit experience.Customer-facing quality experience.Front-room audit support experience.Regulatory affairs exposure including FDA submissions, 510(k) processes, or product registration activities.Validation experience including IQ/OQ/PQ.Experience with Power BI, NetSuite, SharePoint, or electronic QMS platforms such as TrackWise, MasterControl, Greenlight Guru, QT9, or similar systems.Work Environment:The work environment is in a medical device manufacturing setting, fully onsite with a 4x10 schedule (Monday to Thursday). The role involves collaboration with various departments and requires a high level of interaction and communication across teams. It is a dynamic and fast-paced environment that focuses on compliance and continuous improvement.Job Type & Location:This is a Contract to Hire position based out of Irvine, CA.Pay and Benefits:The pay range for this position is $57.00 - $63.00/hr. 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)Workplace Type:This is a fully onsite position in Irvine, CA.Application Deadline:This position is anticipated to close on Aug 7, 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 without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email View email address on click.appcast.io for other accommodation options.San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall 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 applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.