The Sr Validation Engineer, QA provides cross-functional support in V&V development, planning and execution while maintaining corporate engineering and quality systems best practices, policies and procedures. The Sr Validation Engineer, QA is results oriented and has the knowledge and confidence in the areas of Quality Assurance and validation/verification (V&V).
Duties and Responsibilities (Key Deliverables):
Bachelor’s Degree from an accredited institution required; Master’s Degree preferred
· Minimum 7 years experience in the medical device industry
· Advanced level of technical software proficiency
· Excellent Quality System knowledge required
· Strong time management and project management skills are necessary.
· Experience writing IQ/OQ/PQ V&V protocols.
· Working knowledge of principles, concepts and practices of process V&V activities, Risk Management, FDA and ISO Regulations.
· General understanding of sterilization and related analytical testing is a plus.
· Must be able to work independently and in a team environment.
Functional/Technical Knowledge, Skills and Abilities Required:
· Statistical expertise in areas such as process capability, process assurance and sampling
· Expertise in Microsoft Office products
· ASQ Certifications preferred
· Advanced level of technical software proficiency.
· Working knowledge of statistical analysis and sampling plans.
· Excellent communication (written and verbal) skills.
· Excellent organization skills.