Quality Engineer
Quality Engineer
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Job Description:
- Seeking a hands-on 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 cross-functional 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.
- Detail-oriented with a proactive approach to problem-solving and continuous improvement.
- Excellent communication and documentation skills.
- Minimum of 10 years of experience in Quality Management.
- Minimum of 5 years of experience PRI-Nadcap accreditation program.
- Lead Auditor Iaw AS9100 and ISO19011.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Contract
Employment Type
Contract
