Job Description

QA Engineering Manager- Chelmsford, MA

How will you make an impact?
Position Summary:
This position leads the Engineering and Quality Assurance functions for the Chelmsford, Massachusetts facility. The holder of this position is a member of the Site Leadership Team and carries the responsibility for end-to-end management of the Engineering and Quality functions at the Chelmsford factory.
The Engineering and Quality Assurance Manager leads the Site2019s Engineering and Quality Teams in the resolution of problems and continuous improvement of product, processes and the Quality Management System. The position requires the ability to inspire and maintain continuous focus on the customer, and to lead through LEAN leadership methodologies that include Standard Work that insures daily accountabilities, rapid deployment of effective counter-measures, and continuous improvement of processes that enable the site to be a low cost, high quality producer serving global markets.

What will you do?
Job Duties and Responsibilities:

* Maintain a Quality Organization at the cutting edge by anticipating and identifying customer needs and priorities and integrating them into the Quality System
* Establish goals and objectives that stretch boundaries by detailing specific continuous improvement activities focused on enhancing internal process and yields
* Establish and drive strategies to obtain site productivity targets
* Interact both vertically and horizontally in a way that commands both personal respect and mission acceptance and possess the ability and interpersonal skills to influence all levels of the organization. Interact with Customers and Suppliers, when required, applying these same attributes as required to promote external relationships and properly represent the interests of Thermo Fisher Scientific.
* Promote LEAN Enterprise approaches with a quality principled focus that includes Daily Standard Work and continuous disciplined focus on processes.
* Implement the performance measurements necessary to effectively evaluate organizational performance and trends in product quality, services, customer satisfaction and the cost of poor quality. Use the results of performance evaluation to target improvement efforts
* Communicate customer, regulatory and organizational requirements to assure product quality, contract compliance and customer satisfaction
* Oversee the effective documentation and implementation of the Quality Management System to assure compliance with customer and regulatory requirements and the standards set by internal policy
* Ensure that individuals performing functions affecting quality are trained and demonstrate the appropriate skills and performance results
* Maintain Corrective Action System to analyze and correct nonconforming conditions and complaints.
* Pro-actively engage with the New Product Development quality and supplier quality teams to insure the rapid development and launch of superior new products.
* Act as a change agent for improvement initiatives
* Create and maintain both a Quality-centric and Quality-focused culture for all production activities
* Perform all job duties in a safe manner and obey all safety policies and procedures
* Perform as a Role Model Leader, acting in compliance with the Thermo Fisher Code of Ethics and the 4-I Values (Integrity, Intensity, Involvement and Innovation).

How will you get there?
Minimum Requirements/Qualifications:

* A minimum of a Bachelor Degree in an appropriate scientific degree required. Chemical processing a plus.
* Minimum four years of experience in progressive roles in manufacturing.
* Regulatory experience in International Standards ISO-9001 or similar regulated industry required. Experience with ISO-13485 and 21 Code of Federal Regulations (CFR) Part 820 Food and Drug Administration (FDA) Quality Systems Regulation (QSR) desirable.
* Experience in world class Quality practices including LEAN Leadership methodologies, root cause analysis, preventative action deployment and quality function tools
* Excellent planning, organizational and communications skills. Experience in leading teams in the implementation of quality improvements systems resulting in reduced cost and cycle times with improved quality of products and services
* Certification by the American Society for Quality (ASQ) as a Certified Quality Engineer (CQE) or Certified Quality Manager (CQMgr) preferred
* Able to travel (domestic and international) up to 20%
* Physical Demands:
* Ability to sit at a computer workstation in an office environment
* Ability to frequently walk, sit, talk, hear, smell and see/distinguish color
* Ability to climb and descend stairs, stand, bend, stretch, reach and kneel while intermittently being exposed to noise, fumes, dust and dirt while in manufacturing area
* Ability to occasionally lift up to 40 pounds

At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission2014enabling our customers to make the world healthier, cleaner and safer.