Director Quality
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Job Location:
Fremont, CA - USA
Monthly Salary:
$ 175000 - 235000
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
As part of the Thermo Fisher Scientific team youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.DESCRIPTION:
As Director of Quality at Thermo Fisher Scientific youll lead strategic quality initiatives that directly impact healthcare and scientific advancement. Youll oversee comprehensive quality systems and operations while fostering a culture of continuous improvement and regulatory compliance. Working with site leadership and cross-functional teams youll drive quality excellence across manufacturing testing and product development activities. This role offers the opportunity to influence quality standards that ensure the safety and effectiveness of products while partnering with customers and regulatory authorities to maintain the highest levels of compliance.
REQUIREMENTS:
Advanced Degree plus 6 years of experience or Bachelors Degree plus 8 years of experience in FDA-regulated industry (pharmaceutical medical device or diagnostics)
Preferred Fields of Study: Life Sciences Engineering Chemistry or related scientific/technical field
Professional certifications (ASQ RAPS) advantageous
5 years of quality management/leadership experience
Extensive knowledge of cGMP ISO standards (9001/13485) and global regulatory requirements
Demonstrated success leading quality systems and regulatory inspections
Strong expertise in risk management CAPA change control and quality processes
Experience managing customer relationships and quality agreements
Experience building and developing effective quality teams
Strong communication and presentation skills
Demonstrated ability to implement organizational change
Strong analytical and problem-solving capabilities
Project management expertise
Strategic planning and budget management experience
Up to 30% travel required including international
Experience with quality management software systems
Ability to work effectively in matrix environment and across multiple sites
Compensation and Benefits
The salary range estimated for this position based in California is $175000.00$235000.00.This position may also be eligible to receive a variable annual bonus based on company team and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on which includes:
A choice of national medical and dental plans and a national vision plan including health incentive programs
Employee assistance and family support programs including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO) 10 paid holidays annually paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave) accident and life insurance and short- and long-term disability in accordance with company policy
Retirement and savings programs such as our competitive 401(k) U.S. retirement savings plan
Employees Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits please visit: Experience:
Director
Key Skills
- Quality Assurance
- FDA Regulations
- ISO 9001
- Root cause Analysis
- Biotechnology
- Clinical Trials
- Quality Systems
- Food Processing
- Quality Control
- Quality Management
- cGMP
- HACCP
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
