26 days old

Senior Manager, Quality Systems

California City, CA 93505
Location :
US - California - San Jose
Job Description

When you join us at Thermo Fisher Scientific, you’ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

How will you make an impact?

The Senior Manager, Quality Systems will manage quality systems and provide leadership to a team based in San Jose, California.

What will you do?

  • Overall management and effectiveness of the management system
  • Manage Quality System, Customer Complaints, CAPA, Training, Records Management, Internal/External Audits and inspections.
  • Provide ongoing strategic review and continuous improvement of the Quality System and initiatives utilizing robust project management and PPI methodologies.
  • Collaborate with business partners to develop and implement innovative business solutions.
  • Provide technical support to all audits and inspections order to remain in conformance with ISO 9001, ISO 13485 standards and compliance with FDA, and all other U.S. and international regulatory requirements
  • Manage and collaborate cross functionally and be able to influence appropriate outcomes
  • Manage a team of 4 quality personnel
  • Management of organizational performance and succession planning through training and development
  • Maintain a culture of high employee engagement, collaboration, flexibility and competitiveness by increasing business and scientific acumen, industry knowledge and executional skills.
  • Establish and maintain internal and external audit processes in compliance with ISO, Regulatory agencies, corporate and customer requirements
  • This position is responsible for other duties as assigned.

How will you get here?
  • Bachelor’s degree or higher is required preferably in technical/scientific field, e.g. engineering, chemistry, biology, or mathematics.
  • A minimum of 10 years Quality Systems experience in a healthcare regulated industry (Medical Device preferred) is required.
  • A broad-based technical knowledge and skills in business areas such as Quality Engineering, Quality Assurance, Quality Systems, Supplier Quality, Regulatory and Quality Compliance is required.
  • Experience within an FDA QSR and ISO environment is required. Experience in communicating with FDA and other internal external auditors
  • Expert knowledge of the US FDA Quality System Regulations and ISO 13485, along with a demonstrated track record of delivering best in class results in the Quality Systems area.
  • Strong collaboration and influencing skills with team building and development capabilities.
  • A demonstrated record of overcoming resistance to change, and driving the adoption of new business processes from a position of direct and indirect/informal authority
  • Excellent relationship building and persuasion skills with the ability to motivate and influence others
  • Excellent verbal and written skills to successfully communicate to a variety of internal and external audiences, while counseling, negotiating and formally presenting views and/or technical criteria clear and assertive communication style
  • Certification as ISO 9001, 13485, GMP Lead Auditor a plus
  • Excellent organizational and time management skills
  • Ability to travel 10-20%

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Apply today! http://jobs.thermofisher.com

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance.

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.


Posted: 2019-10-16 Expires: 2019-11-22

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Senior Manager, Quality Systems

California City, CA 93505

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