Validation Integration Engineer - Medical Device

Qualifications:

8+ years of QSR/Manufacturing/Quality experience in Medical Device Industry - 4+ years Process Validation Experience - Strong technical, problem solving, and statistical background - Effective communication skills - Project Management skills - Training and education skills - Process development experience - Knowledge of analytical and statistical tools, including Designs of Experiments Must be willing to travel 50-75% Must have a valid passport

Responsibilities:

- Working with sites to ensure local Implementation of validation procedures - Ensure validation support structure and document handling system are developed and sustainable - Host training and educational sessions appropriate for associates relevant to validation procedures. - Establish mentoring process to improve effectiveness of validation work - Support and influence change management at site - Liaison between Validation Network, Unit Program Manager and Quality Management - Work with Validation Network to develop sustainable validation program at the sites - Represent integration sites on the Validation Network - Participate in regulatory audits and inspections, as needed - Monitor effectiveness of validation integration, identify areas of improvement and support continuous improvement efforts specific to validation at sites.