Quality Engineer

Job DescriptionJob DescriptionResponsibilities:

• Support validation process through protocol drafting, approval and execution and providing validation training and guidance.
• Chair Process Change Review Board and participate in Validation Review Board meetings.
• Participate in Design Transfer/Change Control projects as the Quality Assurance Core Team Lead.
• Lead improvement initiatives for Quality Assurance.
• Independently perform full range of standard work.
• Identify and resolve more complex problems and apply problems-solving skills to handle most situations.
• Use statistical analysis and risk management techniques.
• Provide guidance for process changes, including guidance on validation requirements.
• Lead CAPA investigations.

Requirements:

• In depth working knowledge and practical application of process validation requirements (IQ/OQ/PQ) and TMV, with ability to develop and support creation of protocols and reports.
• Proven ability to lead projects.
• In-depth knowledge of requirements related to ISO 13485 and FDA QSR
• Strong knowledge of Risk Management and Design Controls/Design Transfer/Change Control..
• Experience with product transfers and new product development projects.
• Experience with problem solving techniques and CAPA investigations.
• Strong organizational skills and ability to prioritize.
• Experience working in medical device or regulated industry.
• Proficient with Microsoft Excel, including use of pivot tables.
• Perform statistical analysis using standard software such as Minitab.
• Ability to make decisions and communicate effectively to multiple levels.
• Bachelor's degree in science or engineering field of study
• Certified Quality Engineer (CQE) Six Sigma Certification experience ..
• 5-8 years of successful experience in medical device and quality engineering, and successful demonstration of Responsibilities and Knowledge as listed above.