Immediate need for a talented
Supplier Quality Engineer – Medical Devices. This is a
06+ months contract opportunity with long-term potential and is located in
Texas(Remote). Please review the job description below and contact me ASAP if you are interested.
Job ID:26-28471
Pay Range: $40 - $47/hour. Traveler benefits as per agency package. (Benefits vary by vendor and assignment.)
Key Responsibilities:- Manage and support supplier quality activities throughout the product lifecycle.
- Evaluate and qualify suppliers based on quality, technical, manufacturing, and regulatory requirements.
- Monitor supplier performance and identify opportunities for continuous improvement.
- Partner directly with suppliers to investigate and resolve quality issues.
- Support Supplier Corrective Action Requests (SCARs), CAPAs, NCRs, and root-cause investigations.
- Review and evaluate supplier quality documentation and corrective-action responses.
- Support Supplier Change Requests (SCRs) and assess the impact of supplier changes on product quality and performance.
- Review and support IQ/OQ/PQ and process validation activities.
- Support Test Method Validation (TMV) activities as required.
- Work cross-functionally with Engineering, Manufacturing, Quality, Regulatory Affairs, Sourcing, and other stakeholders.
- Analyze supplier quality metrics, nonconformances, inspection results, and other quality data.
- Identify recurring supplier issues and develop corrective and preventive improvement strategies.
- Support supplier development and process improvement initiatives.
- Ensure supplier activities remain aligned with applicable FDA requirements, ISO 13485, and company quality-system requirements.
- Support quality activities associated with product and manufacturing transfers.
- Apply quality engineering tools such as pFMEA, MSA, Gage R&R, SPC, and root-cause analysis where appropriate.
- Provide technical quality guidance related to supplier processes, components, specifications, and manufacturing activities.
Key Requirements and Technology Experience:- Experience with Test Method Validation (TMV).
- Experience with MSA / Gage R&R.
- Experience with pFMEA / PFMEA.
- Knowledge of SPC and statistical quality tools.
- Experience with GD&T / geometric tolerancing.
- Experience with Control Plans and receiving inspection requirements.
- Experience with Supplier Owned Quality (SOQ).
- Experience maintaining or supporting an Approved Supplier List (ASL).
- Experience with TrackWise, Oracle Agile PLM, SAP, or similar quality/enterprise systems.
- Lean Manufacturing or Six Sigma experience.
- Experience supporting product transfer, manufacturing transfer, or supplier change programs.
Our client is a leading
Medical Equipment Manufacturing Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.
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