We are seeking Validation Engineers to lead site-wide process validations at state of the art medical devices manufacturing sites at various locations around the U.S. All candidates for validation engineer should have a depth of experience in applicable FDA and foreign medical device regulations, including ISO 13485 and MDD 820. We work with global medical industry leaders who are looking for top talent in validation engineering
Our clients seek quality assurance and validation engineers who are career driven, have strong analytical and technical skills, and a depth of experience in the process validation of medical devices. Our companies offer excellent career growth potential, and excellent benefits. We have many opportunities, all with top medical device companies seeking cutting edge engineering talent in quality and validation.
typical roles and responsibilities for Validation Engineer
- Run process qualifications including Instillation 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.
- Lead Engineering team in the qualification of new equipment for inspection, including development and validation of routines for automation of complex visual inspection systems.
- Perform training to procedural and quality system changes.
- Facilitate Risk Management process in compliance to appropriate external standards and corporate policies.
- Drive Quality Engineering activities designed to improve customer satisfaction and achievement of company quality objectives.
- Has advanced knowledge in the areas of Quality Assurance, Process Validation, Design Controls, Risk Management and Statistical Techniques.
- Responsible for ensuring compliance with all Federal, State, local and company regulations, policies and procedures.
Requirements for the Validation Engineer - Medical Devices
- Bachelor's degree in engineering, science or technical discipline; advanced degree preferred
- 5+ years of progressive experience in medical device engineering
- 3+ experience medical device quality assurance and validation
- Extensive experience with IQ, OQ, PQ
- Expert level knowledge of ISO 13485, MDD 820
- Knowledge of GD&T including ability to read and interpret complex mechanical drawings.
- Strong organization skills. Excellent verbal and written communication skills.
- Ability to handle multiple tasks simultaneously and ability to manage project timelines.
- Strong analytical and statistical skills
- Excellent communications skills, oral, written and electronic.
- Must be accurate in handling detailed information/data.
- Ability to travel up to 10% of the time.
Salary range for Validation Engineer