Sr. Validation Engineer
California, San Francisco
Our client, a Global Leader in the Medical Device Industry has an immediate opening for a Sr. Validation Engineer for a 12 month + Contract. Our client offers results-driven people a place where they can make a difference every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.
Position Description (Principle Duties and Responsibilities)
Manufacturing Transfer Quality Engineering function that enables successful transfers by driving quality, cost transformation and service improvements for our customers whilst remaining compliant to both internal and external standards.
Will work within the QA Shared Services Manufacturing Transfer Team, responsible for quality related activities as it applies to Manufacturing Transfer, these include but not limited to the following:
Supporting all transfers globally
Having knowledge of and ability to provide interpretation and guidance on Regulations, Corporate and Site Local procedures as they relate to quality activities such as FMEA, MSA s, Validations and Qualifications.
Point of contact for quality for manufacturing transfers at Scoping, Planning and Execution phases
Enable successful completion of manufacturing transfer to achieve its quality, cost and time requirements
Be able to identify MT quality risks/gaps and provide solutions to correct
Technical Quality Expert that sets quality strategy by utilizing a risk based approach around FAI s, Inspection Certification, leveraging etc.
Provide expertise for at least 2 quality specialty associated with manufacturing transfer
Manufacturing Transfer Independent Reviewer as required
Supports Manufacturing Transfer Process training where required
Provides feedback to lessons learnt for each completed manufacturing transfer
Drive continuous optimization of Manufacturing Transfer Process
Excellent communication skills and attention to detail.
Have a good understanding of engineering and machine tool fundamentals.
Strong knowledge of Quality Concepts and Risk Based Techniques (e.G. FMEA, Risk, Statistics).
High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
Continuous Improvement Mindset
Lean Six Sigma training a distinct advantage.
Must be willing to work as part of a multi-site team, be able to travel as part of the job
Bachelor of Science, Engineering or related subject and 5 to 7 years of experience in quality, or Masters of Science, Engineering or related subject with 4 years of experience in quality
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