Quality Assurance Engineer III

3 weeks ago


Middletown, Virginia, United States Thermo Fisher Scientific Full time

About the Job:

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We're looking for a Quality Assurance Engineer III - Formulation and Fill Operations to join our team in Middletown, VA. In this role, you'll be responsible for determining and implementing quality assurance procedures, processes, and standards.

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Your Responsibilities Will Include:

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  • ">
  • Determining and implementing quality assurance procedures, processes, and standards">
  • Collaborating with various teams to ensure flawless execution of quality control activities">
  • Conducting rigorous testing and analysis to identify areas for improvement and optimization">
  • Monitoring and collaborating with team members for daily operational compliance to the quality management system (QMS) and other Regulatory, ISO, and international standards.">
  • Improving product and process quality through direct support and monitoring of value stream production and new development.">
  • Leading and supporting the investigation of nonconformance, audit findings, CAPA's, complaints, environmental alerts and SCAR's by conducting CAPA investigations, risk assessment (FMEA, DFMEA, PFMEA), root cause analysis and effectivity checks.">
  • Assisting with the preparation and approval of change control documents related to the operation and improvement of Operations processes.">
  • Competing in a fast-paced environment to meet strict deadlines">
  • Conducting internal and participating in external Quality System audits to assess the compliance with the QMS, FDA regulations, ISO standards, EU IVDR and any other international regulations and internal requirements.">
  • Successfully implementing continuous improvement initiatives to enhance overall quality and efficiency.">

Requirements:

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  • ">
  • Bachelor's degree in engineering or a related field, and 5 years of relevant experience; OR Master degree and 3 years of experience.">
  • Understanding of global regulatory and quality requirements associated with medical devices such as ISO 13485, ISO 14971, 21 CFR Part 820">
  • Knowledge of IVDR and MDR, a plus.">
  • Experience working in a liquid formulation and fill operation, a plus">
  • ASQ certified quality engineer, ASQ certified quality auditor, and/or Six Sigma/Lean certified, a plus">

What We Offer:

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  • ">
  • 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">

About Thermo Fisher Scientific:

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We are an EEO/Affirmative Action Employer and do 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.

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Salary Range: $120,000 - $150,000 per year, depending on experience.



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