Quality Engineer II

Job Summary:
Seeking a Quality Engineer II to improve value assignment processes, review and revise validation plans, complete risk assessments, and support implementation activities.

Job Requirements:

• BS Degree in a relevant field

• Experience with risk assessments (ISO 14971)

• Knowledge of IQ, OQ, PQ validation processes

• Experience in Quality Management Systems (QMS) investigations related to nonconformances and CAPAs

Preferred Skills:

• Experience in process improvements and validation plan reviews in the medical device or pharmaceutical industry

• Familiarity with regulatory standards and compliance

Job Responsibilities:

• Improve value assignment processes and ensure alignment with industry standards

• Review and revise validation plans, including risk assessments in accordance with ISO 14971

• Support implementation activities for new processes and equipment

• Assist with critical QMS investigations related to nonconformances and CAPAs

• Validate new processes and equipment through IQ, OQ, PQ stages

• Collaborate with cross-functional teams to ensure quality and compliance standards are met

Pay: 38-48

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: $38.00 to $48.00 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

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The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.