More jobs:
Quality Engineer
Job in
Irvine, Orange County, California, 92604, USA
Listed on 2026-02-17
Listing for:
Actalent
Contract
position Listed on 2026-02-17
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering, QA Specialist / Manager -
Engineering
Quality Engineering, QA Specialist / Manager
Job Description & How to Apply Below
1) word copy of resume
2) 2-3 professional references
3) 4-5 brief bullet points highlighting technical qualifications
Description
Job Title:
Quality Engineer / Quality Lead - QMS Separation & Harmonization (Long Term Contract)
Location:
Irvine, CA - Hybrid/ Onsite (Preferred)
Remote option available for the right candidate, supporting Pacific Time, Eastern Time and Internationally
Start Date:
Late March
Duration: 14-month contract with potential for extension
________________________________________
Position Summary
We are seeking an experienced Quality Engineer / Quality Lead (6-10 years) to support the separation of a medical device company from a parent organization and the transition to a stand alone Quality Management System (QMS). This role requires a strong understanding of how QMS elements interact across functions and the ability to execute an existing transition and harmonization strategy.
The ideal candidate is a hands on "doer", comfortable assessing procedures, implementing change, executing document migrations, and driving day to day quality system activities rather than defining enterprise level strategy.
________________________________________
Key Responsibilities
QMS Transition & Harmonization
- Develop a deep, working understanding of the current Quality Management System and support the transition out of the parent quality system into a stand alone QMS.
- Evaluate existing procedures, work instructions, records, and quality system elements to determine what should be retained, modified, or removed as part of the separation.
- Execute quality system harmonization and improvement activities in alignment with defined project plans and quality plans.
PLM / Document Migration (Windchill)
- Serve as Quality Lead working with the Windchill PLM team to map and execute the migration of all quality system document types into a new system container, including:
o Procedures
o Work Instructions
o Parts
o Specifications
o Quality Records
- Ensure proper document structure, metadata, traceability, and compliance throughout the migration.
Change Management & Implementation
- Support the development and hands on implementation of change management processes required to enable QMS separation.
- Execute change controls, document updates, approvals, and training impacts associated with quality system changes.
Project Execution & Monitoring
- Lead day to day quality execution activities tied to the overall QMS separation project.
- Monitor project progress, identify issues or risks, and recommend and implement corrective actions.
- Maintain project schedules and provide regular status updates to Quality and project stakeholders.
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Required Qualifications
- 6-10 years of Quality Engineering experience in the medical device industry
- B.S.E. or related field of study
- Strong working knowledge of QMS structure, interactions, and execution
- Hands on experience with:
o QMS transitions, system separations, or major quality system changes
o Document control and change management
o PLM systems (Windchill experience strongly preferred)
- Solid understanding of global medical device regulatory requirements
- Ability to work independently, manage details, and drive tasks to completion
Skills
windchill, quality management system, EU, EUMDR, Quality assurance, qms, design transfer, Engineering, change management, quality engineering, work instruction, QMS Implementation, medical device, traceability
Top Skills Details
windchill,quality management system
Additional
Skills & Qualifications
Desired Candidate Profile
- A hands on executor, not a high level strategist
- Comfortable implementing decisions and direction defined by leadership
- Able to work cross functionally with Quality, Regulatory, IT/PLM, and business teams
- Thrives in fast paced environments with shifting priorities during organizational change
Experience Level
Expert Level
Job Type & Location
This is a Contract position based out of Irvine, CA.
Pay and Benefits
The pay range for this position is $70.00 - $71.11/hr.
Eligibility…
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