Quality Engineer
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Job Location:
Monthly Salary:
Posted on:
8 hours ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
First Shift (Days)Environmental Conditions
Cleanroom: no hair products jewelry makeup nail polish perfume exposed piercings facial hair etc... allowedJob 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:
Join Thermo Fisher Scientifics Quality Assurance team and contribute to our mission to make the world healthier cleaner and safer. As a Quality Engineer II you will ensure compliance with quality standards and regulatory requirements across our manufacturing operations. Youll collaborate with cross-functional teams to drive continuous improvement initiatives lead investigations and implement corrective actions to maintain our high standards of product quality. This role offers exposure to innovative technologies and the opportunity to directly impact patient care through quality oversight of critical products.
REQUIREMENTS:
Expirance in molding process measurement systems.
Advanced Degree with no prior experience or Bachelors Degree plus 2 years of quality assurance experience in GMP/ISO regulated environments preferably in medical devices pharmaceuticals or biotechnology
Preferred Fields of Study: Life Sciences Engineering Chemistry or related scientific/technical field
ISO 13485/FDA Lead Auditor certification beneficial
ASQ certification (CQE CQA) advantageous
Strong knowledge of quality systems cGMP regulations and standards including ISOCFR Part 820
Expertise in quality tools and methodologies including risk management root cause analysis CAPA and change control
Demonstrated experience leading investigations analyzing quality data and implementing effective corrective actions
Excellent documentation and technical writing skills for developing SOPs protocols and reports
Strong proficiency in quality management software (TrackWise SAP QM etc.) and Microsoft Office suite
Experience conducting internal audits and supporting external regulatory inspections
Demonstrated ability to build consensus and collaborate across functions
Strong verbal and written communication skills
Ability to work independently while contributing effectively in team environments
Strong attention to detail with analytical and problem-solving capabilities
Experience with statistical analysis tools and quality metrics reporting
Project management skills and ability to prioritize effectively
Ability to work in clean room environments when required
Foreign language skills beneficial
Required Experience:
IC
Key Skills
- APQP
- Quality Assurance
- Six Sigma
- ISO 9001
- PPAP
- Minitab
- Root cause Analysis
- ISO 13485
- Quality Systems
- Quality Management
- As9100
- Manufacturing
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
