Quality Engineer

Job Description

Job Description

Description

Position Summary We are seeking an experienced Senior Quality Engineer to support and enhance Quality Management System (QMS) compliance within a regulated medical device manufacturing environment. This individual will play a key role in maintaining and improving quality systems, supporting internal and external audits, managing supplier quality initiatives, driving CAPA activities, and collaborating cross-functionally with Engineering, Manufacturing, and Regulatory teams. The ideal candidate is highly self-motivated, thrives in a fast-paced environment, and takes ownership of identifying and resolving quality and compliance issues with minimal direction. Quality Systems & Regulatory Compliance Maintain and improve Quality Management System (QMS) processes in compliance with FDA QMSR, ISO 13485, ISO 9001, and ISO 14971 requirements. Support regulatory activities including FDA submissions, 510(k) documentation, design controls, risk management, and change management processes. Lead and support preparation for FDA, ISO, customer, and third-party audits. Audit Management Plan, conduct, and report internal quality audits. Lead supplier audits and supplier quality assessments, including travel as required. Support external regulatory and customer audits by coordinating responses, evidence collection, and corrective actions. Quality Operations Manage CAPA, non-conformance, complaint/customer feedback, and investigation activities. Facilitate Material Review Board (MRB) and CAPA Review Board meetings, ensuring effective follow-up of actions and deliverables. Lead root cause investigations and implementation of corrective and preventive actions. Support engineering change control and document control activities. Validation & Risk Management Develop, execute, and review validation protocols and reports including IQ, OQ, and PQ activities. Support risk management processes and design control deliverables throughout the product lifecycle. Analyze quality trends and metrics to identify improvement opportunities and reduce risk. Cross-Functional Leadership Coordinate activities across Engineering, Manufacturing, Regulatory Affairs, and Quality functions. Provide quality leadership on product and process improvement initiatives. Deliver training and coaching to personnel on quality systems, compliance requirements, and best practices. Prepare and present quality metrics, management review presentations, and trend analyses. Reporting & Analytics Utilize Excel, Power BI, and PowerPoint to analyze quality data and create meaningful reports and dashboards. Track KPI performance, audit findings, CAPA effectiveness, supplier performance, and QMS health metrics. Required Qualifications Bachelor's degree in Engineering, Quality, Life Sciences, or a related technical field. 5+ years of Quality Engineering experience within a regulated medical device environment. Strong working knowledge of: FDA QMSR 21 CFR 820 ISO 13485 ISO 9001 ISO 14971 Design Controls CAPA Systems Change Control Risk Management Experience conducting internal, supplier, customer, and regulatory audits. Experience supporting product and process validations (IQ/OQ/PQ). Strong understanding of supplier quality management. Advanced proficiency with Microsoft Excel, Power BI, and PowerPoint. Excellent communication, organizational, and project management skills.

Skills

Quality engineering, capa, iso standards, qms, Quality assurance, quality management, quality management system, quality management systems, Supplier quality, Quality control, Apqp, Corrective action plans, Medical device, Root cause analysis, regulatory, regulatory compliance, iq, pq, oq, fda, Audit, Iso 9001, Iso 13485, 501K, change control, engineering change control, project management, Risk management, Fmea

Top Skills Details

Quality engineering,capa,iso standards,qms

Additional Skills & Qualifications

Experience within a medical device contract manufacturing environment. Experience supporting 510(k) submissions and regulatory affairs activities. ASQ CQE, CQA, or related quality certification. Experience leading supplier development and supplier quality improvement programs.

Experience Level

Expert Level

This is a Contract to Hire position based out of Irvine, CA.

The pay range for this position is $57.00 - $67.00/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)

This is a fully onsite position in Irvine,CA.

This position is anticipated to close on Aug 8, 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 ziprecruiter.com 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.