Senior Developer - MDR, 510(k), DHF Remediation

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:

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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