Quality Systems & Process Improvement Lead
Quality Systems & Process Improvement Lead
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1 Vacancy
Job Description
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.
Excellent Benefits Package
Review our companys Total Rewards
Medical Dental & Vision benefits-effective Day 1
Paid Time Off & Holidays
401K Company Match up to 6%
Tuition Reimbursement eligible after 90 days!
Employee Referral Bonus
Employee Discount Program
Recognition Program
Charitable Gift Matching
Company Paid Parental Leave
Career Advancement Opportunities
Location/Division Specific Information
This role is remote-based with a primary location at our Middletown VA site within the SDG division. Travel requirement: 20-25%.
Discover Impactful Work:
As the Quality Systems & Process Improvement Lead you will drive process optimization change management and document control to enhance compliance and efficiency within the Quality Management System (QMS). You will play a key role in ensuring alignment with ISO 13485 FDA regulations and company policies while fostering a culture of continuous improvement.
A day in the Life:
- Lead process improvement initiatives to enhance efficiency compliance and standardization within the QMS.
- Oversee the Change Control process ensuring risk assessment documentation accuracy and effective implementation.
- Improve document control activities including creation revision approval and training on quality system procedures.
- Support internal and external audits by ensuring documentation and process adherence.
- Collaborate with cross-functional teams to drive continuous improvement projects and CAPA initiatives.
Keys to Success:
Education
Bachelors degree in Engineering Quality Life Sciences or a related field required; however combinations of education training and significant work experience will be considered.
Experience
- 5 years of experience in quality systems process improvement or change management in a regulated industry.
- Hands-on experience with ISO 13485 FDA 21 CFR 820 and other relevant quality system regulations.
- Experience with electronic QMS document control systems and CAPA management.
Knowledge Skills Abilities
- Strong problem-solving and analytical skills with a structured approach to root cause analysis.
- Proficiency in Lean Six Sigma or other continuous improvement methodologies.
- Excellent communication and collaboration skills to work effectively across teams.
Employment Type
Full-Time
