Thermo Fisher Scientific Manager, Quality Assurance in Middletown, Virginia

Job Description

Position Summary:

This position will lead and provide strategic direction to the Middletown, VA site for Quality Assurance and ensure full compliance of product and systems to regulatory requirements. The candidate will be an insightful leader with abilities to develop and mentor people and implement strategic and tactical plans to drive sustainable improvements. This customer facing role will require excellent interpersonal and communication skills in addition to attention to detail and a strong sense of urgency.

Key Responsibilities:

  • Overall site leader for Quality Assurance activities. Develop and maintain quality assurance systems and processes that ensure products are made to specification, meet customer and regulatory requirements, and create customer satisfaction. Provide oversite of the NCR system, product record review, product release, COA and material acceptance.

  • Embrace the 4-I corporate values of Integrity, Intensity, Innovation and Involvement and role modeling the values.

  • Develop and implement Quality Assurance policies and procedures supporting 21 CFR 820/ISO13485/MD-SAP/CE compliance.

  • Establish and manage Quality Assurance activities to ensure product quality and customer satisfaction. Work with operations to establish good manufacturing practices and improve quality culture.

  • Drive continuous improvement of Quality Assurance processes to improve quality, increase efficiency and eliminate waste. Establish, monitor and report appropriate metrics to monitor state of control and process improvement.

  • Hire, train and develop Quality Assurance staff to ensure high performance and continuity of staffing. Identify high performers and create development plans to prepare them for additional responsibilities and contributions.

  • Lead and participate in cross functional teams in new product development, technology transfer, process improvement and general operations.

  • Facilitate and participate in regular product and process quality reviews including Management Review.

  • Assist with investigations of process variance, nonconforming materials and complaints.

  • Establish, organize & monitor the annual Quality Plan improvement efforts

  • Act as resource during FDA inspections, Notified Body (Management Representative), customer audits and other third party Quality System evaluations.Author, change and update Quality Manual and QA procedures as applicable

Minimum Requirements/Qualifications:

Position requires a 4-year degree in a technical/science area; an advanced degree is

preferred. Five or more years in an FDA regulated industry with 3 or more years in a management position is also required. Significant experience with quality systems in an IVD/Medical device environment is also required. Incumbent must possess strong interpersonal and communication skills.

Critical Hiring Criteria:

  • Excellent relationship building and persuasion skills with the ability to motivate and influence others. Proven ability to work with people in a diverse work environment.

  • Well-developed verbal skills to successfully communicate to a variety of internal and external audiences, while counseling, negotiating and formally presenting views and/or technical criteria.

  • Must be skilled and experienced in acting in a consultant role, with a demonstrated record of overcoming resistance to change, and driving the adoption of new business processes from a position of indirect or informal authority.

  • Communicate openly and honestly

  • Focus on growth

  • Champion employee development

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.