Senior Quality Assurance Engineer
2 weeks ago
Standard (Mon-Fri)
Environmental Conditions
Compliance with all Good Manufacturing Practices (GMP) Safety Standards, Office environment, with some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs, etc.).
Job Overview
Are you a seasoned Engineer eager to leverage your expertise in a pivotal role? Thermo Fisher Scientific Inc. is on the lookout for a Senior Quality Assurance Engineer who has demonstrated a history of impactful contributions to join our esteemed team.
This position is based in Middletown and offers a unique opportunity to make a significant difference.
Key Responsibilities:
- Establish and execute quality assurance protocols, processes, and standards.
- Collaborate with diverse teams to ensure impeccable execution of quality control measures.
- Perform thorough testing and analysis to pinpoint areas for enhancement and optimization.
- Oversee and collaborate with team members to ensure daily operational adherence to the quality management system (QMS) and other regulatory, ISO, and international standards.
- Enhance product and process quality through direct support and oversight of production value streams and new developments.
- Lead and assist in the investigation of nonconformance, audit findings, CAPA's, complaints, environmental alerts, and SCAR's by conducting CAPA investigations, risk assessments (FMEA, DFMEA, PFMEA), root cause analysis, and effectiveness checks.
- Support the preparation and approval of change control documents related to the enhancement of operational processes.
- Thrive in a fast-paced environment to meet stringent deadlines.
- Conduct internal and participate in external Quality System audits to evaluate compliance with the QMS, FDA regulations, ISO standards, EU IVDR, and other international regulations.
- Successfully implement continuous improvement initiatives to boost overall quality and efficiency.
Qualifications:
- Bachelor's degree in Engineering or a related discipline, or equivalent experience.
- Demonstrated experience in quality assurance within an engineering context.
- Comprehensive understanding of quality control methodologies and effective strategies.
- Outstanding problem-solving and analytical capabilities.
- Familiarity with global regulatory and quality requirements associated with medical devices, including ISO 13485, ISO 14971, and 21 CFR Part 820.
- Knowledge of IVDR and MDR is advantageous.
- Experience in liquid formulation and filling operations is a plus.
- ASQ certified quality engineer, ASQ certified quality auditor, and/or Six Sigma/Lean certified is a plus.
- Exceptional communication and teamwork skills.
At Thermo Fisher Scientific, we celebrate diverse experiences, backgrounds, and perspectives. We are an equal opportunity employer, dedicated to providing reasonable accommodations for individuals with disabilities during the application process. We look forward to supporting you in your career journey.
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