Sr. Supplier Quality Engineer

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

Benefits offered by this job

Onsite role with limited remote work

Job summary

Terumo Medical Corporation is seeking a Supplier Quality Manager to lead the supplier quality program across Manufacturing, R&D, Supply Chain, and Quality Engineering, ensuring purchased components meet specifications and regulatory requirements.

The role requires seven years in supplier quality, knowledge of QA methods, and bilingual English/Spanish communication. Onsite work with up to 10% remote is supported, targeting continuous improvement and regulatory compliance in medical devices.

Qualifications

• Experience in medical device supplier quality required.
• Solid understanding of quality systems and CAPA processes.
• Ability to perform supplier evaluations and audits.

Responsibilities

• Lead supplier quality management program across functions (Manufacturing, R&D, Supply Chain, Procurement, Quality Engineering).
• Review new supplier requests and assess impact on QMS and controls.
• Facilitate supplier qualifications, site evaluations, and quality agreements.
• Drive improvements using Six Sigma DMAIC, FMEA, SPC and Lean concepts.
• Manage SCAR process and supplier nonconformance investigations.
• Maintain KPI data and supplier scorecards for continuous improvement.
• Ensure compliance with FDA/regulatory requirements for medical devices.

Skills

Medical devices

Quality systems

CAPA & RCA

Bilingual EN/ES

Statistical methods

Education

Bachelor’s degree in related engineering field

Tools

Excel

QA tools

Job description

Lead the Supplier Quality Management program by working closely with Manufacturing, R&D, Supply Chain, Procurement, and Quality Engineering teams to ensure that the suppliers and the related purchased components or services meet specifications and other requirements.

DUTIES AND RESPONSIBILITIES

• This associate is responsible for implementing the supplier management process. This includes:
• Review of all new supplier add/change requests for impact on Quality Management System and required controls as follows:
• Assess the suitability of suppliers to meet requirements through supplier evaluations, including supplier questionnaires, quality agreements and supplier site evaluations.
• Work closely with suppliers and R&D, Supply Chain, Procurement, and Quality Engineering groups to ensure potential suppliers for development projects meet requirements for qualification.
• Facilitating and performing component/material qualifications as follows:
• 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 / MSA studies are needed.
• Ongoing supplier management activities as follows:
• 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 as follows:
• Maintains and analyzes Key Performance Indicators (KPIs) and Cost of Poor-Quality (CoPQ) data to identify recurring trends and drives improvement actions to reduce internal and external failure costs.
• Work with suppliers, Supply Chain, and Procurement 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.
• Supplier Nonconformance Management as follows:
• Provide support during investigation and root cause determination of relevant supplier nonconformances.
• Lead implementation of the Supplier Corrective Action Request (SCAR) process.
• Responsible to stay current with FDA, applicable regulatory requirements and industry trends regarding regulations and expectations for the medical device industry.
• Provide leadership and guidance to a team of hourly and/or salary associates, including assigning tasks, setting clear goals, and monitoring performance.
• Facilitate training sessions to ensure team members are equipped with necessary skills and knowledge. Develop individual team members through coaching and mentoring.
• Conduct regular performance evaluations, provide constructive feedback, and implement performance improvement plans as needed. Recognize and reward outstanding performance.
• Ensure smooth operations by coordinating workflows, resolving issues, and addressing concerns promptly. Maintain high standards of quality, productivity, and efficiency.
• Foster a positive work environment through effective communication.
• Encourage collaboration and teamwork to achieve organizational goals.
• Contribute to a positive work environment by fostering open communication with team members, other departments, and management, promote teamwork, and commitment to excellence.
• Ensure compliance with all TPR procedures and all applicable regulatory agency requirements.
• Other duties as assigned.

POSITION REQUIREMENTS

Knowledge, Skills and Abilities (KSAs):

• Knowledge of medical product manufacturing and development is preferred, though knowledge from other regulated industries (e.g. automotive, space/military, food, pharma) may be considered.
• 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 TPR’s products.
• Good interpersonal and communication skills.
• Must be bilingual (English & Spanish).
• Understanding of CAPA and closed loop corrective action processes.
• Strong technical business writing and oral communication skills.
• Proficient in spreadsheet (report formatting, graphing, formula a calculation generation), database, presentation, and project management tools.
• This is an onsite role. Maximum remote work: 10%
• Bachelor’s or advanced degree in a related engineering field or equivalent.
• Minimum of (7) seven years of related experience in supplier quality.
• Certification as a Quality Engineer or Quality Auditor by the American Society for Quality is preferred.
• Trained / Certified in Six Sigma and Lean methodology is preferred.
• Experience evaluating suppliers including on-site auditing. ISO Lead Auditor certification is preferred.