Position Overview
This position is for a Quality Engineer, reporting to the Sr. Quality Manager, with primary responsibility for Process Validation activities in manufacturing. This person will work with cross functional teams to determine validation activities required for projects as well as engineering and process changes. This person will support the validation roadmap for the site. This role will also support Design Transfer/Change Control projects as needed. This role requires excellent organizational skills, analytical problem-solving skills, the ability to effectively communicate at a technical level as well as with management, and in-depth understanding of quality system requirements.

Responsibilities
This position will be responsible for being the Quality Assurance lead for Validation as well as supporting Design Transfer and other change projects, including engineering and process change projects.

The person in this role will:
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 in order to handle most situations
Use statistical analysis and risk management techniques
Provide guidance for process changes, including guidance on validation requirements
Lead CAPA investigations

Required Knowledge/Skills, Education, and Experience
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

Preferred Knowledge/Skills, Education, and Experience
Bachelor s degree in Science or Engineering field of study
Certified Quality Engineer (CQE) Six Sigma Certification experience preferred
5-8 years of successful experience in medical device and quality engineering, and successful demonstration of Responsibilities and Knowledge as listed above