Quality Management System Specialist
1 month ago
At Thermo Fisher Scientific, we are seeking a highly skilled QMS Engineer to join our team. As a QMS Engineer, you will play a critical role in ensuring the quality and compliance of our medical devices.
Key Responsibilities:- Develop, implement, and maintain the Quality Management System (QMS) in compliance with relevant regulatory standards, including FDA and ISO 13485.
- Conduct internal audits and assessments to ensure compliance with quality standards and identify areas for improvement.
- Collaborate with multi-functional teams to maintain quality objectives, key performance indicators, and metrics.
- Track and analyze quality data to identify trends, issues, and opportunities for process improvement.
- Facilitate and participate in management reviews to drive continuous improvement efforts.
- Handle regulatory or customer inspections and audits, as necessary.
- Assist in the development and delivery of training programs related to the QMS.
- Lead document periodic review and coordinate with internal parties to maintain and update all necessary documentation to align with system requirements.
- Establish site policies and procedures in maintaining the QMS.
- Identify and implement process improvement opportunities, cost improvement, and monitor the efficiency.
- Bachelor's degree in engineering or a related field.
- Solid understanding and experience with relevant quality standards and regulations, including FDA QSR and ISO 13485.
- Previous experience working in the medical device industry and familiarity with QMS requirements specific to this industry.
- Proficiency in conducting internal audits and assessments.
- Certified ISO13485:2016 internal auditor is preferred.
- A minimum of 3-5 years' proven experience in medical device (IVD) manufacturing environment.
- Experience in a regulated industry preferred.
- Capacity to work both independently and in a team-orientated environment.
- Strong and effective communication and interpersonal skills to collaborate with multi-functional teams.
- Strong attention to detail and ability to work with complex documentation.
- Excellent analytical and problem-solving skills.
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