Quality Engineer II

Support sustaining engineering, complaint investigations, CAPA, nonconforming material evaluation, and validation activities for regulated medical device products.

Job Requirements

• Minimum of approximately five years of relevant engineering or quality experience

• Medical device industry experience

• Experience supporting sustaining engineering activities

• Experience performing complaint investigations

• Experience with CAPA processes

• Experience evaluating nonconforming material

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

• Experience with design controls

• Experience performing risk analysis

• Experience developing or maintaining FMEAs

• Experience working within regulated quality systems

Preferred Skills

• Master’s degree in Engineering or a related technical field

• Experience with catheters

• Experience with sterile disposable medical devices

• Experience supporting product and process changes

• Experience with failure investigation and root cause analysis

• Experience with verification and validation activities

• Experience supporting manufacturing quality and production issue resolution

• Experience maintaining risk management documentation

Job Responsibilities

• Support sustaining engineering activities for commercial medical device products

• Investigate product complaints and document technical findings

• Support CAPA investigations, root cause analysis, and corrective actions

• Evaluate nonconforming materials and product discrepancies

• Support material review and disposition activities

• Develop and execute process validation protocols for IQ, OQ, and PQ

• Support design control activities for product and process changes

• Perform product and process risk analyses

• Develop and update FMEA documentation

• Investigate manufacturing and field performance issues

• Support verification and validation activities associated with sustaining changes

• Maintain engineering and quality documentation within applicable quality systems

• Support manufacturing teams with technical evaluation of product and process issues

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 Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

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

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.