Job Summary
Key Responsibilities
1. To support the quality strategy, Annual Plans and review the functioning / performance of the respective clusters including: - Consolidation of CMMI and ISO certifications aligned to industrialized delivery and sustain the Level 5 Maturity - Deployment o
2. To deliver consistent and predictable delivery quality across all verticals & horizontals through capability building / product quality focus. Enable the evaluation of projects based on the critical parameters
3. To deploy standardized delivery processes cutting across verticals & horizontals and ensuring the continuous improvement of systems by leveraging the reuse of knowledge, process assets and best practices for the respective cluster.
4. To improve consistency and efficiency of quality operations through convergence and economies of scale.
5. To promote high maturity culture in an industrialized environment.
Skill Requirements
SCAR Implementation and Closure:
- Open SCARs must be taken through formal closure- Implement corrective actions and formally close all open SCARs with appropriate evidence by 30 September.
- 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 (i.e., Mechanical) with 7-8 years in supplier quality function.
- 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.