Basic Job Purpose: Support NPI products and compliance to applicable standards and regulations through design transfer, process and test method validation.
Main Duties:
· Collaborating with R&D to Manufacturing, supports the creation and execution of design transfer activities for both internal and external manufacturing.
· Collaborating with R&D, Operations and Purchasing ensures that designs are properly transferred to internal manufacturing or external suppliers align with SOPs.
· Support development and execution of process and test method validation activities for newly products. Provides input to R&D and Engineering for the proper creation and maintenance of site master validation plans.
· Support the development and maintenance of product specific quality plans.
· Responsible for quality plan, FAI plan and reports.
· Support continuous improvement activities to reduce product failure rates
· Responsible for failure investigation activities for released products. Failure investigations include but is not limited to incoming quality rejections, in-process test failures, final release test failures, and returned product investigations. Investigation activities may include disposition of individual rejections reports and CAPAs.
· Responsible for the development, application, and reporting of quality metrics that where appropriate utilize Statistical Process Controls and statistical techniques.
· Review and approval of DMR and DHR for NPI and Change request type A and B
· Qualification and certification of suppliers, including audits.
REQUIREMENTS
· Bachelor’s Degree in Life Science or second degree in felids of quality and statistics.
· Proven experience in Quality systems %28minimum 8 years%29
· Certified as lead auditor
· Experience working in an FDA and ISO 13485 regulated environment
· Project Management skills, strong communication, problem solving and analytical skills are required.
· Strong English capabilities – a must
