Quality Engineer
Quality Engineer
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Job Description:
The client is seeking a handson Quality Engineer with experience in medical and implantable devices to support and enhance its product assurance and regulatory compliance programs. This role focuses on ensuring the quality and integrity of new and existing products in accordance with FDA ISO and internal standards. While there are no direct management responsibilities the engineer will play a critical role in maintaining the companys quality systems and promoting regulatory awareness across the organization.
Responsibilities:
- Support and manage core elements of the quality system to ensure compliance with FDA regulations and ISO standards.
- Collaborate with crossfunctional teams to prevent or resolve product defects in both new development and sustaining efforts.
- Drive awareness and implementation of regulatory and customer requirements across relevant functions.
- Contribute to internal and external audits inspections and regulatory submissions.
- Monitor and improve product and process flows for ongoing quality assurance.
Requirements:
- Experience with implantable medical devices strongly preferred.
- Strong knowledge of FDA 21 CFR Part 820 ISO 13485 and related quality/regulatory frameworks.
- Detailoriented with a proactive approach to problemsolving and continuous improvement.
- Excellent communication and documentation skills.
- Minimum of 10 years of experience in Quality Management.
- Minimum of 5 years of experience PRINadcap accreditation program.
- Lead Auditor Iaw AS9100 and ISO19011.
Employment Type
Full Time
