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Supplier Quality Assurance Engineer

2 months ago

Texas, United States BioTalent Full time

The Supplier Quality Assurance Engineer at BioTalent will play a pivotal role in overseeing the quality management of our manufacturing partners. This position demands a proactive approach to deliver results in a dynamic and rapidly evolving environment. The focus will be on collaborating with Manufacturing Engineering and Global Sourcing teams to ensure that our manufacturing partners meet the necessary qualifications and capabilities.

Key Responsibilities:


• Enhance supplier quality by collaborating with partners to implement robust manufacturing processes that guarantee a high level of product conformity through sustainable practices and statistical process controls.


• Actively participate in all facets of an Advanced Product Quality Planning (APQP) based manufacturing and supplier quality program, including the development of Process Failure Mode Effects Analysis (PFMEA), Gage Repeatability and Reproducibility (GR&R), Control Plans, and Process Validation, ensuring that partners adopt processes that promote exceptional quality and conformance.


• Collect pre-shipment and warranty data for specific product lines, utilizing LEAN methodologies to identify root causes and foster continuous improvement initiatives.


• Evaluate new supplier capabilities as part of the selection process.


• Collaborate with cross-functional teams to integrate APQP in significant product development projects and modifications, emphasizing process controls such as PFMEAs, Control Plans, Corrective and Preventive Actions (CAPA), process capability, and continuous improvement. Guide suppliers through the change management process for necessary adjustments.


• Propel continuous improvement by developing, maintaining, and executing quality documentation, including Standard Operating Procedures (SOPs), Standard Inspection Procedures (SIPs), workflows, standards libraries, and manuals.


• Analyze statistical data to define requirements and set quality and reliability targets.


• Conduct regular audits of supplier processes to ensure product and process compliance.


• Foster a culture of quality, reliability, and continuous improvement across the organization through enthusiastic collaboration.

Qualifications:


• A Bachelor's degree in engineering or equivalent experience is essential.


• A minimum of 4 years of engineering experience, particularly with large tonnage, molded-in-color plastic injection components and processes.


• Previous experience in a global full-service supply chain model is preferred.


• Hands-on experience and familiarity with traditional quality tools, including APQP, DFx, FMEA, DOE, GR&R, SPC, CAPA, and PPAP.


• Proficient in utilizing statistical methods and analysis tools effectively.


• Knowledge of a wide range of manufacturing techniques, materials, and tooling, along with good vision and color perception.


• Strong problem-solving skills, risk analysis capabilities, and the ability to make timely quality decisions.


• Demonstrated ability to lead and influence cross-functional teams while being a collaborative team player.


• Additional computer skills are advantageous, including PLM, SharePoint, Salesforce, Tableau, SolidWorks, or other CAD software.


• Willingness to travel both domestically and internationally.

*Compensation for this role includes a salary range of $85,000 to $102,000, along with annual bonus potential.