Posting ID: JP-002025327
QUALITY ENGINEER This position will support the molding quality engineering projects as well as improvements related to applicable processes. • Develop and initiate standards and methods for inspection, testing and evaluation • Devise sampling procedures and design and develop forms and instructions for recording, evaluating and reporting quality and reliability data. • Develop and implement methods and procedures for disposition of discrepant material and devises methods to assess cost and responsibility. • Direct workers engaged in measuring and testing product and tabulating data concerning materials, product or process quality and reliability. • Support Product Engineers and Quality Program Managers with customer interfaces as necessary on quality related issues. • Assure data availability and integrity for all quality related data. Consolidate and report quality results. • Initiate corrective action requests as needed and track to satisfactory completion. • Responsible for developing, applying, revising and maintaining quality standards for processing materials into partially finished or finished products. • Design and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and/or production equipment. • Investigate customer complaints. • Approve product, process and equipment qualification.
Medical device, Quality engineering, Capa, fmea, iso 13485, injection molded
Top Skills Details:
CAPA FMEA Medical Device manufacturing Injection molding
Additional Skills & Qualifications:
REQUIRED • Bachelor's degree in engineering • Minimum 3-5+ years of Quality experience in the Medical Device industry • Strong experience writing and developing inspection plans and visual defect references • Knowledge of Process Validation for medical device industry (IQ/OQ/PQ) • Working knowledge of CAPA (corrective and preventative action) and FMEA • Demonstrated knowledge of multiple functional technologies/ processes related to product manufacturing including molding • Strong verbal, customer-facing, and written communication skills PREFERRED • Plastic injection molding operations knowledge • Demonstrated knowledge of compliance to ISO 13485 and FDA 21CFR 820
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.
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.
Recruiter: Jovanovic, Shane