Sr Quality Engineer

Support medical device quality systems and post-market quality activities, including CAPA ownership, root cause investigations, surveillance reporting, design changes, and supplier quality records.

Job Requirements

• Bachelor’s degree with 5+ years of medical device industry experience, or Master’s degree with 3–4 years of relevant experience.

• Experience with medical device quality systems and quality operations.

• Experience with post-market surveillance activities.

• Experience owning and coordinating CAPAs.

• Experience performing root cause analysis.

• Experience authoring quality and post-market surveillance documentation.

• Experience supporting design change activities.

• Experience supporting supplier corrective action records.

Preferred Skills

• Experience supporting implantable or infusion-based medical devices.

• Experience working with contract manufacturers.

• Experience performing periodic quality document reviews.

• Experience supporting supplier quality activities.

• Experience coordinating quality activities across manufacturing, operations, and design functions.

Job Responsibilities

• Author post-market surveillance reports for released medical devices and accessories.

• Coordinate and own CAPA activities from initiation through closure.

• Perform root cause investigations related to product and quality system issues.

• Conduct periodic reviews of quality system documentation.

• Support quality system and quality operations activities.

• Support design change reviews and associated quality documentation.

• Coordinate supplier corrective action records.

• Work with contract manufacturing quality and operations teams on product and quality issues.

• Support quality activities involving design, manufacturing, and supplier functions.

• Maintain documentation required for post-market surveillance, CAPA, and quality system compliance.

Pay: 40-53/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 $53.00 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.