Sr. Validation Quality Engineer - United States
- Responsible for the development and oversight of the Quality System validation program at the site.
- Develops and executes IQs, OQs and PQs for manufacturing and quality systems software and process validations.
- Reviews existing processes and software for compliance to medical device validation requirements and reports/mitigates any gaps.
- Develops in-depth knowledge of products, manufacturing processes, and software used in the process and in quality systems.
- Works with the Supplier Quality team to review supplier validation processes/documents.
Duties and Responsibilities:
- Develop and execute IQ, OQ, and PQ validation protocols for production processes, equipment and software, as well as quality system software.
- Develop and execute test method validations for process and product testing.
- Write reports summarizing results for equipment, process or software validation projects.
- Review existing validation reports and identify/mitigate gaps for compliance to requirements
- Review supplier validation programs,processes and documentation and support improvements.
- Conduct or lead corrective and preventive actions in quality systems or validations using problem solving techniques.
- Conduct or lead internal and supplier audits of validation programs and processes.
- Develop understanding of production processes and production software/inspection software to support continuous improvements or corrective/preventive actions.
- Participate as an active new product development core team member
- Support quality system projects and activities such as engineering change order support and complaint investigation support.
- Support FDA inspection readiness activities.
- Perform other duties as assigned.
- Bachelor of Science degree from an accredited college or university in an Engineering or Science discipline and 5-8 years of process/software validation experience in medical device industry
- Experience in the medical device industry in the development and deployment of quality systems, validations, process controls and continuous improvement methods.
Knowledge, Skills & Abilities:
- Working knowledge of Medical Device Regulations and Standards (FDA, ISO 13485, ISO 14971, MDD, IVDD)
- Proficient in root cause analysis, verification & validation, process flow mapping
- Experience with scientific instrumentation in a design and manufacturing environment
- Independent problem solving skills
- Computer proficiency with background in Agile and SAP business information systems a plus
- Energetic, results-driven with excellent organizational and prioritization skills.
- Excellent written and verbal communication skills and highly effective time management skills.
- Ability to operate independently and as part of a team
- Commitment to continuous improvement principles.