Design Quality Engineer III- Supervisor

Design Quality Engineer responsible for DHF remediation, design control documentation, risk management updates, traceability gap closure, and audit readiness support. Job Requirements Strong understanding of quality engineering principles Strong understanding of design controls and DHF documentation requirements Experience performing gap assessments, evidence collection, and documentation remediation Experience creating and updating design inputs, design outputs, verification and validation documentation, and traceability records Experience maintaining risk management tools, including DFMEA and Hazard Analysis Experience ensuring end-to-end traceability and identifying documentation gaps Experience supporting quality systems and regulatory compliance activities Experience tracking project progress, risks, and action items Ability to analyze data and resolve quality or compliance issues Ability to work independently under general direction Experience interpreting quality procedures, policies, and regulatory requirements Preferred Skills Experience with DHF remediation planning, including scope, assumptions, and acceptance criteria Experience coordinating approvals with R D, Manufacturing, Regulatory Affairs, and Document Control Experience supporting audit readiness and audit responses Experience leading remediation or quality improvement projects Experience closing design control gaps in regulated environments Experience supporting patient safety and product quality requirements Experience contributing to process improvements within quality systems Job Responsibilities Support DHF remediation activities, including gap assessments, evidence collection, and documentation updates Assist in remediation planning, including scope, assumptions, and acceptance criteria Create and update DHF documentation, including design inputs, design outputs, verification and validation records, and traceability documentation Maintain risk management tools, including DFMEA and Hazard Analysis, in alignment with DHF requirements Ensure end-to-end traceability across design and quality records Identify and close documentation, traceability, and compliance gaps Coordinate with R D, Manufacturing, Regulatory Affairs, and Document Control to obtain reviews and approvals Support audit readiness activities and audit response preparation Track remediation progress, project risks, and action items Apply problem-solving methods to resolve quality and compliance gaps Ensure adherence to quality systems, regulatory standards, and patient safety requirements Support process improvements related to quality engineering and design controls

Pay:

50-54/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.