Job ID :
US - California - Sunnyvale
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 Program Manager QMS will play a key role in the ICSP Business Unit's Initiative to achieve and maintain ISO 9001:2015 conformance, improvement to processes and procedures, documentation, record keeping and Quality Fundamentals. This individual will be working in a position of collaboration and influence to guide or direct quality system and fundamentals activities in adherence to the quality policy. Key elements of the program include a top down re-engineering of the QMS, leading management reviews and managing programs within the quality system such as, but not limited to, calibration program, CAPA coordination, training, onboarding programs and adhering to emerging standards.
Key Duties and Responsibilities
Responsible for Leading and maintaining the quality fundamentals.
Contribute strategically to BU overall quality strategy, best practices, and guidance for all ICSP functions by working collaboratively with all functions.
Lead the internal audit program and external audits.
Lead and Administer Internal Document Review Program.
Documented Information for conformance to ISO Standard, applicable company policies and effectiveness.
Lead development of continuous improvement, including metrics development.
Assist in the review and disposition of deviations/non-conformance and complaints.
Lead and Manage Change Control process for QMS procedures and documented information.
Prepares and assists with the Management Review.
Support and backfill for QARA Mgr as Management Rep, as applicable.
Coach/mentor others to become leaders with focus on customer experience of product quality.
Develop and lead quality programs onboarding training for new employees.
Administer the training program tracking, metrics and reporting.
Lead and administer the calibration program, interfacing with 3rd party calibration vendor.
Minimum Qualifications/ Requirements
Bachelor's Degree in the Scientific or Technical field (i.e. Chemistry, Biology, or Engineering) preferred.
5+ years of related work experience with a hardware device or consumable manufacturing environment adhering to ISO 9001 standards or higher.
Medical Device, Biotechnology or Pharmaceuticals experience a plus.
Proven effective communication skills are required, both written and verbal.
Strong ISO Internal Audit experience, with Audit Certification from a certified body (e.g. ASQ and/or RABQSA) a plus.
Strong Calibration Program Management experience.
Strong CAPA experience.
Ability to leverage tools such as Visio and SharePoint a plus
Proven attention to detail and appropriate, diligent follow up.
Excellent interpersonal skills, problem solving skills, planning/organization skills, strategy and customer focus.
Demonstrated organizational knowledge of product development to manufacturing to distribution.
Ability to handle multiple tasks while ensuring timely and accurate completion.
Ability to work independently.
Proficient with personal computer skills, specifically Microsoft office applications, with the ability to learn new computer systems quickly.
LEAN Sigma or experience with Toyota Production System based quality system a plus.
This position has not been approved for relocation.
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 missionenabling our customers to make the world healthier, cleaner and safer.
Apply today! http://jobs.thermofisher.com
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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.
Thermo Fisher Scientific Inc.