Aerotek Validation Engineer in Longmont, Colorado
process validations for manufacturing
ISO 13485 MDD 820.
Run process qualifications including Installation Qualification, Operational Qualification and Performance / IQ OQ PQ. Develop, design and execute validation protocols Review and approve engineering change control, plant validation protocols and reports Establish, coordinate and act as subject matter expert for the site's Master Validation Plan, schedule, execution of schedule, validation police and practice Write, review and approve validation change controls and validation protocols IQ/OQ/PQ PV standard operating procedures, standard calibration methods, standard test methods, specifications CAPAs and exception reports.
Validation, Iq, Oq, Pq, ISO 13485, Design control
Top Skills Details:
validation ISO 13485 Design control Verification/Validation QMS CAPA
Additional Skills & Qualifications:
BS engineering, science or technical discipline 5+ years engineering in ISO 13485 environment 3+ experience medical device quality assurance and validation IQ, OQ, PQ
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.