Quality Engineer

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 with in 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

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 - $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…