Quality Engineer

Quality Engineer II responsible for sustaining engineering, complaint investigations, CAPA, nonconforming material evaluation, process validation, design control, and quality support for medical device products.

Requirements

• Medical device industry experience

• Approximately 5+ years of Quality Engineering experience

• Master’s degree may be considered in lieu of some experience

• Experience with sustaining engineering

• Experience with complaint investigations

• Experience with CAPA

• Experience evaluating nonconforming material

• Experience with catheters or sterile disposable medical devices

• Experience with process validation, including IQ, OQ, and PQ

• Experience with design control

• Experience with risk analysis

• Experience with FMEA

• Experience supporting product development or design change activities

• Experience supporting regulatory and quality requirements for medical devices

• Experience with reliability testing

• Experience with verification and validation

• Experience with manufacturing process development

• Onsite availability

• Availability to work standard business hours, with flexibility to start earlier or stay later as needed

Preferred Skills

• Catheter product experience

• Console product experience

• Experience supporting new medical device product development

• Experience supporting design changes to existing medical device products

• Experience with manufacturing transfer activities

• Experience with input requirements and early design feasibility testing

• Experience with product risk management requirements

• Experience in a contract-to-hire environment

Responsibilities

• Ensure new catheter and console products meet regulatory and quality requirements

• Support design changes to existing medical device products

• Participate in product development activities from design through manufacturing transfer

• Support sustaining engineering activities

• Investigate product complaints

• Support CAPA activities

• Evaluate nonconforming materials

• Support process validation activities, including IQ, OQ, and PQ

• Support design control documentation and deliverables

• Perform risk analysis and FMEA activities

• Support development, reliability testing, input requirements, feasibility testing, verification, and validation

• Support manufacturing process development activities

• Support product risk management requirements

• Work with cross-functional teams to ensure quality requirements are met throughout development and transfer

Pay: 40-50/hr

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client.

Pay Details: $40.00 to $50.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

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• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

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