Supplier Quality Engineer I - Supplier Changes

Changing lives. Building Careers.

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

The Supplier Quality Engineer I (SQE) responsible for managing the Supplier Change Request (SCR) process plays a vital role in ensuring that any changes made by suppliers to materials, processes, or designs are thoroughly evaluated, meet Integra’s quality standards, and are implemented seamlessly. This role involves reviewing and approving SCRs, collaborating with suppliers and cross-functional teams, conducting risk assessments, and ensuring ongoing compliance with regulatory and quality requirements while minimizing production disruptions.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

Supplier Change Request Management:

• Serve as the central point of contact for all suppliers’ change requests.
• Review and validate SCR documentation for completeness and accuracy.
• Collaborate with suppliers to gather necessary information for proposed changes.
  
  

Cross-Functional Collaboration:

• Coordinate with cross-functional teams, including Quality, Regulatory, R&D, and Operations, to evaluate the impact of proposed changes.
• Ensure alignment between internal stakeholders and supplier activities.
  
  

Process Compliance:

• Maintain accurate and up-to-date records of SCR activities in the designated quality management system (QMS).
  
  

Communication and Reporting:

• Provide regular updates on the status of SCRs to stakeholders and leadership.
• Generate metrics and reports to monitor and improve the efficiency of the SCR process.
  
  

Continuous Improvement:

• Identify opportunities to streamline the SCR process and improve overall efficiency.
• Support initiatives to enhance supplier performance and compliance.
  
  

Reporting and Metrics:

• Monitor SCR performance, including cycle times, approvals, and compliance rates.
• Prepare and present reports and dashboards to track process effectiveness and drive decision-making.
  
  

Qualifications

The requirements listed below are representative of the knowledge, skill and/or ability required for his position.

• Bachelor’s degree in engineering, Quality Management, Supply Chain, or a related field.
• Six Sigma, ASQ, or other quality-related certifications are a plus.
• 0-2 years of experience in supplier quality, manufacturing, supply chain, or quality systems in the medical device, pharmaceutical, or life sciences industry.
• Familiarity with ISO 13485, FDA regulations, and other applicable standards.
• Strong organizational and project management skills.
• Excellent written and verbal communication abilities.
• Proficiency in QMS software and tools.
• Analytical mindset with a focus on risk assessment and problem-solving.
  
  

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

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