Senior QA Engineering Specialist
4 hours ago
Job Summary:
">We are seeking a highly experienced Senior QA Engineering Specialist to join our team in Middletown, VA. As a key member of our Quality Assurance team, you will be responsible for determining and implementing quality assurance procedures, processes, and standards.
">About the Role:
">- ">
- Determine and implement quality assurance procedures, processes, and standards">
- Collaborate with various teams to ensure flawless execution of quality control activities">
- Conduct rigorous testing and analysis to identify areas for improvement and optimization">
- Monitor and collaborate with team members for daily operational compliance to the quality management system (QMS) and other Regulatory, ISO, and international standards.">
- Improve product and process quality through direct support and monitoring of value stream production and new development.">
- Lead and support 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.">
- Assist with the preparation and approval of change control documents related to the operation and improvement of Operations processes.">
- Compete in a fast-paced environment to meet strict deadlines">
- Conduct internal and participate 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 implement continuous improvement initiatives to enhance overall quality and efficiency.">
- ">
Requirements:
">- ">
- 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">
- ">
Benefits:
">- ">
- 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:
">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.
">Salary Range: $120,000 - $150,000 per year, depending on experience.
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