Experience Inc. Jobs

Job Title: Quality EngineerJob Description

• 5+ years of experience as a Quality Engineer in manufacturing medical devices. - Good understanding of regulatory compliance for Quality Management Systems per ISO & CFR 820 Part 21. - Knowledge and use of the following standards: IEC, ISO, EN, IEC, ISO 5841, ISO. - Proficient in Design Control. - Knowledge of PCBA design and manufacture. - Understanding of firmware & software and its verification/validation. - Proficient in Equipment Management (calibration & PM). - Experienced in Process Validation (Equipment and Process - IQ/OQ/PQ). - Skilled in Risk Management (dFMEA/pFMEA, hazard analysis, risk-benefit analysis). - Knowledge of CAPA, Complaint (MDR) and complaint handling, RGA (return goods), and NCR. - Experience with CMO’s (contract manufacturer organizations), Supplier Controls (evaluation, approval, monitoring), evaluation & disposition of supplier ECO’s (Engineering Change Orders), Receiving Inspection of devices and components. - Familiar with medical device labeling, symbology, UDI – use and implementation of printers (or equivalent). - Knowledge of medical device packaging.

Hard Skills

• Quality Management Systems

• ISO & CFR 820 Part 21

• IEC, ISO, EN, IEC, ISO 5841

• Design Control

• PCBA design and manufacture

• Firmware & software verification/validation

• Equipment Management

• Process Validation

• Risk Management

• CAPA and Complaint Handling

• Supplier Controls

• Medical device labeling and 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. Medical device startup with 12 employees locally. The system was developed for the treatment of chronic post-amputation phantom limb and residual limb pain using patented Bioelectric On-Demand Nerve Block Technology to target pain at the source, the affected peripheral nerves. Just received PMA.

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.