Immediate Quality Engineering Opportunity

* For Immediate Consideration Please apply to this posting and email your resume to habels@actalentservices.com*

Job Description

We are seeking a seasoned Quality Engineer with over 5 years of experience in manufacturing medical devices. The ideal candidate will have a robust understanding of regulatory compliance for Quality Management Systems per ISO & CFR 820 Part 21. You will work with various standards including IEC, ISO, EN, IEC, ISO 5841, and ISO. Responsibilities include design control, PCBA design and manufacture, firmware & software verification/validation, equipment management (calibration & PM), process validation (IQ/OQ/PQ), and risk management (dFMEA/pFMEA, hazard analysis, risk benefit analysis). Additional duties encompass handling CAPA, complaint (MDR) and complaint handling, RGA (return goods), and NCR. You will also work with CMO’s, supplier controls (evaluation, approval, monitoring), evaluation & disposition of supplier ECO’s, and receiving inspection of devices and components. Experience with medical device labeling, symbology, UDI (or equivalent) printers, and medical device packaging is essential.

Hard Skills

• Regulatory compliance for Quality Management Systems per ISO & CFR 820 Part 21

• Knowledge and use of standards: IEC, ISO, EN, IEC, ISO 5841, ISO

• Design Control

• PCBA design and manufacture

• Firmware & software verification/validation

• Equipment Management (calibration & PM)

• Process Validation (IQ/OQ/PQ)

• Risk Management (dFMEA/pFMEA, hazard analysis, risk benefit analysis)

• CAPA, Complaint (MDR) and complaint handling, RGA, NCR

• CMO’s, Supplier Controls, evaluation & disposition of supplier ECO’s

• Receiving Inspection of devices and components

• Medical device labeling, symbology, UDI

• Medical device packaging

Job Type

This is a contract position with a duration of 1 Year(s).

Work Site

This is a fully on-site position in Aliso Viejo, California.

Work Environment

Medical device design and prototype assembly

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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

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 actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.