job description
Join Knowles Electronics, a global leader in advanced micro-acoustic, audio processing, and precision device solutions, as a Senior/Specialist QMS Engineer (MedTech). In this pivotal role, you will drive the development, implementation, and continuous improvement of our Quality Management System (QMS) to ensure compliance with ISO 9001, ISO 13485, and FDA 21 CFR Part 820 standards. Based in the vibrant regions of Bali, you will collaborate with cross-functional teams to uphold the highest quality standards in our MedTech manufacturing processes.
This is a unique opportunity to contribute to life-saving medical technologies while enjoying the dynamic work-life balance that Bali offers. If you are a detail-oriented professional with a passion for quality assurance and regulatory compliance, we invite you to apply and be part of our mission to deliver excellence in healthcare solutions.
Responsibility
- Develop, implement, and maintain the Quality Management System (QMS) in accordance with ISO 9001, ISO 13485, and FDA 21 CFR Part 820 requirements.
- Lead internal and external audits to ensure compliance with regulatory standards and identify areas for improvement.
- Collaborate with engineering, manufacturing, and R&D teams to integrate quality assurance processes into product development and production.
- Conduct risk assessments and implement corrective and preventive actions (CAPA) to mitigate quality issues.
- Train and mentor staff on QMS procedures, best practices, and regulatory requirements.
- Monitor and analyze quality metrics to drive continuous improvement initiatives.
- Prepare and submit regulatory documentation and reports as required by local and international authorities.
- Stay updated with industry trends, regulatory changes, and emerging technologies in MedTech quality assurance.
Qualifications
- Bachelor’s degree in Engineering, Quality Management, or a related field. Advanced degree preferred.
- Minimum of 5 years of experience in Quality Management Systems (QMS) within the MedTech or medical device industry.
- In-depth knowledge of ISO 9001, ISO 13485, and FDA 21 CFR Part 820 regulations.
- Certification in Quality Management (e.g., CQE, CQA, or equivalent) is a plus.
- Proven experience leading audits, CAPA processes, and regulatory submissions.
- Strong analytical, problem-solving, and project management skills.
- Excellent communication and interpersonal skills to collaborate with cross-functional teams.
- Ability to work independently and manage multiple priorities in a fast-paced environment.