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:

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.