As a Quality System Manager, you will leverage your Quality Systems skills and leadership at a Fortune 500 company where you can influence and build world class process for the Global Quality function across the business. Make connections and partnerships across the business and functions creating value through your subject matter expertise. Partner in key strategic Quality initiatives across the business.
This is a remote position and can be based anywhere within the US.
- Develop and execute programs to improve quality system compliance and efficiency.
- Focus on development of best practice policy and standard operating procedures.
- Work with Senior Director Global Quality Excellence to support oversight QA/RA 20/20 Program and coordinate project management activities within the function.
- Identify upcoming Standards changes and understand work needed to be done to ready the organization.
- Drive Quality KPIs and Management reporting.
- Support Quality IT function to ensure compliance needs are addressed, Quality team is appropriately represented and IT platforms are designed with quality in mind. Ensure QMS policies/procedures appropriately aligned.
- Work with Senior Leadership Regulatory Compliance to identify upcoming/changing regulations and understand work needed to be done to ready the organization.
- Develop and manage appropriate Quality training programs.
- Perform as a Role Model Leader, acting in compliance with the Thermo Fisher Code of Ethics Administer the Division’s overall Quality System, management of the Company’s Quality Assurance and Quality Control departments, assuring that all Company policies and practices meet or exceed all regulatory requirements.
- Bachelor Degree in related Quality / Technical / Operations discipline; MBA preferred.
5+ years of experience in Quality Systems, including working in a matrix organizational structure.
- Demonstrated experience in Quality environment.
- Ability to work in a matrix environment, utilizing influence
- Excellent verbal and written communication skills, comfortable in an executive environment
- Ability to handle conflict with confidence and integrity
- Sound organizational skills and a keen ability to multi-task in a detailed environment
Non-Negotiable Hiring Criteria:
- Extensive knowledge in Quality Systems and associated Regulatory knowledge in a Medical Device environment
- Experience with Computer Systems associated with Quality Processes
- Ability to travel approximately 20% of the time
This position has been approved for relocation assistance.