Design Assurance Engineer - Full-time / Part-time

Seeking a Quality Engineer for a contract position within the medical device industry...

JOB DESCRIPTION:

Support and monitor new product development project needs in design controls for adherence to the internal quality management system and all ISO, FDA, and QSR regulations.
Participate and ensure proper design controls are appropriate during design reviews.
Provide input to operations regarding quality issues such as process improvements and risk (DFMEA & PFMEA) updates.
Manages the pre- & post-production Design Assurance/Quality Engineering activities as they relate to product lifecycle development
Review and approval of validation protocols and reports. Work with Supplier Quality and Supply Chain groups to ensure product suppliers are effectively developed.
Verify configuration management and Risk Analysis records are properly addressed, accurate, and maintained.
Review test protocols and final reports for completeness and accuracy.
Ensure design changes are processed in accordance with current change-control requirements.
Complete assigned tasks on schedule, and identify and propose resolution for issues that may affect the timeline for remediation activities.
Provide quality engineering support for investigations as required.
Coordinate resolution of potential quality assurance deficiencies discovered during the product realization process.

QUALIFICATIONS:

Bachelor's degree with 2 or more years of experience in medical device quality assurance.
Ability to interpret trends and data, translating the information into actions, outcomes and improvements
Excellent documentation skills, with a solid process orientation and effective attention to detail
Proficiency in all MS Office products
Quality engineering certification (ASQ CQE or CQA) a plus
Knowledge of lean six sigma manufacturing processes

Please send resumes

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.

Aerotek is acting as an Employment Agency in relation to this vacancy.