Senior Developer - MDR, 510(k), DHF Remediation
India
Job Description
Senior Developer - MDR, 510(k), DHF Remediation
| Chennai, Tamil NaduMadurai, Tamil Nadu
Job Summary
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Key Responsibilities
SCAR Implementation and Closure:
- Open SCARs (Supplier Corrective Action Request ) must be taken through formal closure- Implement corrective actions and formally close all open SCARs with appropriate evidence.
- Detailed review of open SCAR records to understand current status and gaps. Categorization of SCARs by supplier, product family, age, and severity.
- Supplier follow-ups and coordination, Documentation completeness, Verification of implemented actions and Closure readiness aligned with FDA QSR expectations
- Establish an inspection-ready supplier control framework through procedure gap assessment, ASL validation, and need-based supplier requalification.
- Supplier follow-ups to obtain:
- Containment evidence. Root cause analysis documentation
- Corrective action implementation details
- Verification and documentation of implementation evidence
- Support for effectiveness checks, as defined by client procedures
- Preparation of complete SCAR closure documentation aligned to the client QMS and FDA QSR requirements
Supplier Controls and ASL Remediation
- Gap assessment of the global purchasing & supplier management procedure against actual practices at the El Paso site
- Documentation of identified gaps across process, roles, records, and controls
- Validation of approximately ASL suppliers, including:
- Classification as active or inactive
- Mapping to products and supplier criticality
- Execution of need-based supplier requalification, including:
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- Updated supplier qualification forms
- Risk assessment and supporting documentation review.
- Support for supplier record migration readiness into Teamcenter (as per client-defined scope and rules).
Basic Qualifications:
- Proven ability to lead multiple SCAR Implementation and Supplier Controls projects.
- Proficiency in the use of Microsoft Word, Excel, PowerPoint, Access, Microsoft Project.
- Full time Degree in a relevant engineering field is required with 5 years of experience for Supplier Quality Engineer.
- Candidates with prior experience in Medical Devices will be required.
- Strong written and verbal communications skills. Ability to write and independently manage the required technical documentation.
- Knowledge of the following standards: 21 CFR Part 820, ISO 13485, and ISO 14971.
Skill Requirements
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Other Requirements
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Information at a Glance