Sr. Supplier Quality Engineer - TPR

Job Summary

A Sr. Supplier Quality Engineer supporting the Supplier Management process works closely with Manufacturing, R&D, Supply Chain, and Quality Engineering groups to ensure that the suppliers and the related purchased components or services meet specifications and other requirements. Provide leadership to the Quality Supply Chain teams to deliver the business results and expectations on a day-to-day basis. This position requires having required skills set to handle employee performance and technical issues related to the personnel under his/her charge.

Job Details/Responsibilities

People Management: Lead (organize, plan, direct and control) teams to achieve the expected goals. Motivates and energizes personnel to obtain top performance. Responsibilities include personnel scheduling, evaluating discipline and coaching that includes selection and training of staff. Ensures adequate communication to staff of all required HR related information.

This associate is responsible for implementing the supplier management process. This includes:

• Review of all new supplier add requests for impact on quality system and required controls
• Assess the suitability of suppliers to meet requirements through supplier evaluation, including supplier questionnaires, quality agreements and supplier site evaluations.
• Work closely with suppliers and R&D, Supply Chain and Quality Engineering groups to ensure potential suppliers for development projects meet requirements for qualification.
• Facilitating and performing component/material qualifications
• Assists in the development of DFEMA’s (Design Failure Mode Effect Analysis) and PFMEA’s (Process Failure Mode Effect Analysis) and control plans where required.
• Facilitating validations and component acceptance activities
• Identifying when gage r & r studies are needed

Ongoing supplier management activities:

• Building relationships with suppliers to ensure that purchased components meet specifications
• Drives continuous improvement in supplier performance through utilization tools such as Six Sigma DMAIC, FMEA, SPC, 8D Root Cause Analysis and Lean Manufacturing concepts.
• Optimize process capability on significant characteristics through effective application of statistical analysis techniques and training of Suppliers in problem-solving.
• Provide expert analysis, guidance, and support to Suppliers in Process Improvement.
• Utilize analytical skill sets to implement root-cause analysis and provide recommendations for corrective action.
• Drives Supplier actions to verify component and process quality at the Supplier’s location to reduce the need for incoming inspection activities.
• Manage the Supplier Corrective Action Request process.
• Trending of supplier metrics
• Maintains and analyzes Key Performance Indicators (KPIs) and Cost of Poor-Quality data to identify recurring trends and drives improvement actions to reduce internal and external failure costs.
• Work with suppliers and Supply Chain to establish and manage continuous improvement programs including supplier ratings and supplier score cards.
• Manage databases and files containing information supporting the suitability of suppliers to provide components and services.
• Maintain accessible records for internal and third-party audits.
• Generate a monthly Supplier Performance Report including input from discrepancy reports and supplier ratings.

Supplier Nonconformance:

• Provide Support during investigation and root cause determination of relevant supplier nonconformance
• Lead implementation of relevant Supplier Corrective Action

This associate is responsible to stay current with FDA and International requirements and industry trends regarding regulations and expectations for industry. Ensure compliance with all TPR procedures and all applicable regulatory agency requirements. Other duties as assigned.

Knowledge, Skills and Abilities (KSA)

• Knowledge of medical product manufacturing and development.
• Must have good people skills with the ability to energize and motivate a staff.
• Solid understanding of receiving inspection processes including statistical sampling, component measurement techniques, specifications, and drawings.
• Thorough working knowledge of Quality systems methods and practices (DOE, PFMEA, Control Plans, Lean Manufacturing concepts, DMAIC, Root Cause Analysis, etc.).
• Ability to understand the technology related to TMC’s products.
• Good interpersonal and communication skills.
• Must be bilingual (English & Spanish).
• Understanding of CAPA and closed loop corrective action.
• Strong technical business writing and oral communication skills.
• Proficient in spreadsheet (report formatting, graphing, formula a calculation generation), database, presentation, and project management tools.

Qualifications/ Background Experiences

• Bachelor’s or advanced degree in related engineering field or equivalent.
• At least 2 years of supervisory experience.
• Minimum of (7) seven years of related experience in supplier approval / management
• Certification as a Quality Engineer or Quality Auditor by the American Society for Quality
• Trained in Six Sigma and Lean methodology; certified as well
• Experience working with suppliers on medical product quality issues
• Experience evaluating suppliers including on-site auditing.