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We are seeking a highly skilled Quality Assurance Specialist to join our team at Thermo Fisher Scientific in Tijuana. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality in our manufacturing processes.
Key Responsibilities- Coordinate subordinates in inspection and receiving testing, ensuring compliance with established procedures.
- Participate in CAPA investigations, evaluating and analyzing samples related to customer complaints.
- Develop and implement corrective and preventive actions to address customer complaints and CAPAs.
- Collaborate with a multidisciplinary team to identify root causes of problems and implement effective solutions.
- Ensure that corrective and preventive actions are properly documented and implemented.
- Participate in process and product improvement plans, actively contributing to cost reduction and PPI projects.
- Support Quality Assurance and Quality Manager in external audits, ensuring compliance with ISO 9001 and ISO 13485 standards.
- Coordinate internal non-conformances, utilizing Trackwise System for process management.
- Conduct trend analysis and post-activities related to trend presentations.
- Originator of documents and change control, including DCOs, ECOs, and ECRs.
- Utilize Agile System for project management and deviation tracking.
- Strong understanding of quality management systems and regulatory requirements.
- Excellent communication and leadership skills.
- Ability to analyze complex problems and develop effective solutions.
- Experience with quality management software and systems.
- Strong attention to detail and organizational skills.
We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and detail-oriented individual with a passion for quality assurance, we encourage you to apply for this exciting opportunity.
