Quality Engineer

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