Sr. Supplier Quality Engineer - TPR

Terumo Cardiovascular Group; Caguas (PR); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Annual bonus

Health, dental and vision benefits

401(k)

Job summary

Terumo Medical Corporation is seeking a Sr. Supplier Quality Engineer to lead the supplier management process and ensure purchased components meet specifications.

You will work with Manufacturing, R&D, Supply Chain and Quality Engineering to deliver results and handle performance and technical issues within your team. You will drive supplier evaluations, qualification, DFMEA/PFMEA, validation support, and corrective actions, while building strong supplier partnerships and guiding continuous

Qualifications

• Bachelor's or advanced degree in related engineering field or equivalent.
• At least 2 years of supervisory experience.
• Minimum of seven years in supplier approval/management.
• Certification as a Quality Engineer or Quality Auditor by ASQ.
• Six Sigma and Lean methodology training and certification.
• Experience working with suppliers on medical product quality issues.

Responsibilities

• Lead supplier management process and drive quality improvements.
• Review new supplier add requests and assess impact on quality controls.
• Evaluate suppliers for qualification with QA documentation.
• Collaborate with R&D, Manufacturing, Supply Chain to meet requirements.
• Develop DFMEA/PFMEA and control plans where required.
• Support validations, acceptance activities, and gage R&R studies.
• Build relationships with suppliers and drive continuous improvement.
• Monitor KPIs, CoQ data, and supplier scorecards.
• Coordinate Supplier Corrective Action Requests and follow through.
• Generate monthly supplier performance reports.

Skills

Quality systems knowledge

Statistical analysis

Project management tools

Bilingual English & Spanish

Strong communication

Leadership / people management

Supplier collaboration

Education

Bachelor's or advanced degree in related engineering

Tools

DOE

PFMEA

Control Plans

Lean manufacturing

DMAIC

Root Cause Analysis

Job description

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Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products.

We believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come.

At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients.

Join us and help shape wherever we go next!

Advancing healthcare with heart

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.

• 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

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

It is Terumo's policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.

Final compensation packages may be higher or lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand. We provide competitive and comprehensive benefit options which include: annual bonus, paid vacation, paid holidays, health, dental and vision benefits, 401(k), with matching contributions, tax advantage savings accounts, legal plan, voluntary life and AD&D insurance, voluntary long-term disability, short term disability, critical illness and accident insurance, parental leave, personal leave, tuition reimbursement, travel assistance, and an employee assistance program.