Quality Engineer

Design Quality Engineer responsible for TMV, risk management, V&V, design quality, DHF remediation, and design integration support for Class III vascular medical devices.

Requirements

• Quality Engineering experience in medical device environments

• Experience with New Product Development or Design Quality

• Experience with 21 CFR 820 requirements

• Technical experience developing and executing TMV activities

• Technical experience developing and executing risk management activities

• Technical experience developing and executing verification and validation activities

• Experience with design integration efforts

• Experience with major remediation efforts

• Experience with Design History File remediation

• Experience supporting Class III medical devices

• Experience with vascular devices, including catheters, stents, or guidewires

• Experience working with design documentation, quality records, and regulatory requirements

• Experience providing technical depth beyond participation in team-based TMV activities

Preferred Skills

• Experience with design controls

• Experience with design transfer or design integration

• Experience with DHF gap assessment and remediation planning

• Experience with validation strategy development

• Experience with risk files and hazard analysis

• Experience with test method validation

• Experience with remediation projects involving legacy design documentation

• Experience supporting cross-functional medical device engineering teams

Responsibilities

• Develop and execute TMV activities for medical device design and quality projects

• Develop and execute risk management activities

• Support verification and validation planning, execution, and documentation

• Support Design Quality activities for New Product Development programs

• Support design integration activities for Class III vascular devices

• Perform DHF remediation activities

• Review and update design documentation to support regulatory compliance

• Support remediation of design controls, risk management files, V&V documentation, and technical quality records

• Apply 21 CFR 820 requirements to design quality activities

• Provide technical Quality Engineering support for catheters, stents, guidewires, and related vascular devices

• Identify gaps in design quality documentation and support corrective actions

• Work with engineering and quality teams on integration, remediation, and validation deliverables

• Ensure design quality deliverables align with medical device regulatory and quality system requirements

Pay: 40-54/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 $54.00 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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