Senior Quality Engineer - Entegee

Summary: Seeking a Senior Quality Engineer to manage the end-to-end CAPA process, lead investigations of complex manufacturing product quality and compliance issues, and provide Quality Systems Engineering support.

Requirements:

• Professional level proficiency with MS Office Suite (Outlook, Word, Excel, Power Point, MS Project)

• Extensive understanding and knowledge of principles, theories, and concepts relevant to Quality Engineering

• Working knowledge and understanding of statistical techniques

• Ability to read and interpret drawings

• Proficient knowledge of Quality Engineering concepts relative to the level of role (Senior Engineer)

• Bachelor's degree in engineering required

• 5-7 years experience required

• Working knowledge of the Domestic and International regulatory Medical Device regulations (FDA 21 CFR 820, ISO 13485; and other applicable regulatory requirements)

Responsibilities:

• Manage end-to-end CAPA process with the support of SMEs from a cross-functional team

• Lead investigations of complex manufacturing product quality and compliance issues for all production processes based on engineering principles

• Perform robust root cause analysis investigation, develop, implement corrective actions, establish effectiveness monitoring plans

• Manage all phases of the CAPA process for specific events including documentation, root cause analysis investigation, record management

• Apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements

• Provide Quality Systems Engineering support including Post-Market Quality Engineering support

• Guide others in resolving basic issues in specialized area based on existing solutions and procedures

• Train employees on CAPA procedures.

 

 Pay: 50-60

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: $50.00 to $60.00 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

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.entegee.com/candidate-privacy-information-statement/

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