Senior Quality Engineer, Validation
On-siteGainesville, Florida, United States
Job Summary
Execute validation and verification protocols for medical device processes, materials, and equipment, including IQ, OQ, PQ, SOPs, and WIs. Lead or participate in V&V activities using risk-based approaches and statistical techniques to ensure compliance with FDA and ISO regulations. Manage project dashboards, coordinate training, and maintain auditing programs while identifying and correcting deviations related to manufacturing V&V. Define third-party, customer, and regulatory audits, and lead Corrective and Preventive Actions for non-conformances. Contribute to cross-functional teams on device cleanliness, material testing, and process capability studies.
Required Qualifications
- Bachelor's Degree from an accredited institution
- Advanced level of technical software proficiency
- Excellent Quality System knowledge
- Strong time management and project management skills
- Experience writing IQ/OQ/PQ V&V protocols
- Working knowledge of principles, concepts and practices of process V&V activities
- Working knowledge of Risk Management
- Working knowledge of FDA and ISO Regulations
- Statistical expertise in areas such as process capability, process assurance and sampling
- Expertise in Microsoft Office products
- Ability to work effectively in a team environment
- Excellent communication (written and verbal) skills
- Excellent organization skills
Desired Qualifications
- Master's Degree
- ASQ Certifications
- General understanding of sterilization and related analytical testing
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