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Aerotek Quality Engineer in Dallas, Texas

We are seeking to hire an experienced Quality Engineer for a contract development and manufacturing organization in the Medical Device industry!

The Quality Engineer coordinates and maintains the Quality Assurance activities required for the companies products. This includes but is not limited to process/product/equipment/Sterilization validations, quality system activities both internal and external to site, design control quality assurance activities and provides investigational support for NCR's, CAR's and customer complaints.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

  • Support product development by assisting the Engineering, Supply Chain, Operations and contract manufacture groups as team player with occasional role as team lead in projects

  • Functions as the Quality Assurance representative for the review and approval of CAPA, validations, component and design change activities

  • Assuring GMP and Quality System compliance by revising our validation, supplier quality and quality systems procedures as required by our standard operating procedure

  • Interfacing with customers, suppliers and other internal personnel to perform the required implementation of Corrective and Preventive actions when necessary

  • Issuing periodic reports by developing plans for collecting, summarizing, and reporting on required validations, supplier audits quality systems and CAPA effectiveness

  • Initiating product retention request to quarantine component/product in conjunction with the Quality Management team per applicable procedure

  • Conduct engineering change review, design reviews, and material review board activities according to applicable procedures

  • Manage and participate in Quality System activities such as:

  • GMP training for new and existing employees

  • GMP awareness program

  • Promotion of the quality system

  • Compliance to domestic and international regulations

  • Manage and participate in the Internal and External Audit programs by conducting audits, writing audit reports, distribution of reports and associated non-conformances, follow-up on designated timelines, etc.

  • Acting as a team player completing other duties as requested by the Quality Manager or as needed to facilitate the goals for the organization

  • Assisting contract customers as required to perform Quality or Quality Engineering support on projects.

  • Acts as support for site and vendor third party audits (FDA, Notified body, EPA, State etc)

  • Acts as internal reviewer on Quality systems, specs and change control

About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.

Location: Dallas, Texas

Posting ID: 7230929

Pay Rate:

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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