Manufacturing Engineer
Manufacturing Engineer
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- We are seeking an experienced Manufacturing Engineer to support a comprehensive documentation gap assessment and remediation effort within our medical device manufacturing operations.
- This individual will play a critical role in evaluating and updating manufacturing documentation to ensure compliance with regulatory standards (e.g. FDA ISO 13485) internal quality systems and best practices.
- Conduct detailed gap assessments of existing manufacturing documentation including work instructions SOPs validation protocols and reports.
- Identify deficiencies or non-conformances in documentation relative to applicable regulatory quality and process standards.
- Collaborate with cross-functional teams (Quality Regulatory Production Engineering) to define remediation plans for documentation gaps.
- Review and revise Standard Operating Procedures (SOPs) and Work Instructions (WIs) to ensure clarity compliance and manufacturability.
- Participate in and support validation activities (IQ/OQ/PQ) including review of protocols reports and associated records.
- Assist in the implementation of documentation control improvements to align with quality system requirements.
- Ensure proper traceability version control and alignment between documents and validated processes.
- Support internal and external audits by providing documentation and remediation evidence as needed.
- Bachelors degree in engineering (Mechanical Biomedical Industrial or related field).
- Minimum 3 5 years of experience in a manufacturing engineering role within the medical device industry.
- Demonstrated experience with documentation gap assessments and remediation.
- Familiarity with FDA 21 CFR Part 820 ISO 13485 and validation requirements for medical devices.
- Proficiency with writing and revising SOPs work instructions and validation documentation.
- Strong understanding of manufacturing processes quality systems and process documentation.
- Excellent attention to detail and organizational skills.
- Effective written and verbal communication skills.
Employment Type
Full Time
