Sr. Global Supplier Quality Engineer

Integra LifeSciences•Princeton, FL

About The Position

This Sr. Global Supplier Quality Engineer is responsible for External Manufacturing with hands-on experience and proven success in providing quality leadership and technical support to ensure robust quality systems at the external manufacturing sites. Primary responsibilities are to: Support the development and manufacturing of medical devices in conformance with the Quality System Regulation, ISO 13485, Medical Device Directive, ISO 14971, IEC 60601 and other regulatory standards. Investigate supplier related deviation, non-conformances, and complaints Issue and manage Supplier Corrective Action Requests (SCARs); verify effectiveness of corrective actions. Have an oversight of quality relationships to manage change notifications, establish quality agreements, and maintain strong relationship with Private Label Partners. Lead the identification and resolution of quality issues and complaints, including facilitation of investigation process and development of robust CAPA plans. Perform Quality audits as required Review and approve quality systems documentation, including product disposition, manufacturing instructions, change controls, and process validation documentation. Monitor quality performance of the ExM sites through the development of key performance indicators Analyze data to identify risks and drive implementation of mitigation plans. Build relationships with internal and external partners and influence external manufacturers to continuously improve processes and procedures. Collaborate with External Manufacturers during regulatory audits and inspections. Support Supplier Quality projects and issues as needed Provide oversight during tech transfer and new product introduction activities. Provide guidance and interpretation for industry related regulations within the framework of organizational products and sustaining development processes. Utilize coaching and facilitating skills with program shareholders to ensure proper project management, expectation setting, and best practices are utilized. Other duties as assigned.

Requirements

B.S. in Engineering or associated scientific discipline.
Minimum 5 years Medical Devices or Pharmaceutical experience in Quality or R&D Engineering position.
DMAIC experience
Certified Quality Engineer (CQE)
Certified Quality Auditor (CQA)
Proficient with Minitab.
Coaching and mentoring skills.
Proven ability to directly lead and/or co-lead multiple tasks and projects.
Strong understanding of industry expectations in the areas such as voice of customer, specification development, risk management, design verification and validation, stability studies, sterilization validation, biocompatibility, transportation testing, etc.
Working knowledge of quality engineering principles, supplier management, and manufacturing operations within a regulated industry (preferably medical devices).
Proficient with utilization of quality tools (Six Sigma, Statistical Techniques, Sampling Principles, Risk Assessment, Root Cause Analysis, FMEA, FTA, DOE, etc.).
Working knowledge of electro-mechanical devices, software validation methods, and/or plastics related manufacturing processes (i.e. extrusion, injection molding, RF welding, etc.) is preferred.
Ability to interpret mechanical drawings.
Familiar with gage and inspection techniques.
Strong collaboration, negotiating, and conflict resolution skills.
Fluid verbal and written communication skills.

Responsibilities

Support the development and manufacturing of medical devices in conformance with the Quality System Regulation, ISO 13485, Medical Device Directive, ISO 14971, IEC 60601 and other regulatory standards.
Investigate supplier related deviation, non-conformances, and complaints
Issue and manage Supplier Corrective Action Requests (SCARs); verify effectiveness of corrective actions.
Have an oversight of quality relationships to manage change notifications, establish quality agreements, and maintain strong relationship with Private Label Partners.
Lead the identification and resolution of quality issues and complaints, including facilitation of investigation process and development of robust CAPA plans.
Perform Quality audits as required
Review and approve quality systems documentation, including product disposition, manufacturing instructions, change controls, and process validation documentation.
Monitor quality performance of the ExM sites through the development of key performance indicators
Analyze data to identify risks and drive implementation of mitigation plans.
Build relationships with internal and external partners and influence external manufacturers to continuously improve processes and procedures.
Collaborate with External Manufacturers during regulatory audits and inspections.
Support Supplier Quality projects and issues as needed
Provide oversight during tech transfer and new product introduction activities.
Provide guidance and interpretation for industry related regulations within the framework of organizational products and sustaining development processes.
Utilize coaching and facilitating skills with program shareholders to ensure proper project management, expectation setting, and best practices are utilized.
Manage and develop a team of supplier quality engineers/analysts, providing coaching, performance management, and career development to build a high-performing organization.
Own supplier qualification, risk assessments, and onboarding activities, including quality agreements, approved supplier lists, and ongoing performance monitoring.
Drive supplier audit programs (risk-based audits, re-audits, and for-cause audits), including audit planning, execution, reporting, and follow-up.
Oversee supplier nonconformance management, deviations, and CAPA, ensuring timely root cause analysis, corrective actions, and effectiveness verification.
Partner cross-functionally with Procurement, Operations, R&D, Design Quality, and Regulatory to align supplier quality requirements with business and product needs.
Establish and track supplier quality metrics (KPIs), conduct supplier business reviews, and present performance trends and risks to senior leadership.
Lead continuous improvement initiatives to reduce supplier-related defects, improve process capability, and strengthen supply chain resilience.
Serve as escalation point for supplier quality issues, proactively assessing risk to product quality, compliance, and supply continuity.
Support new product introductions and external manufacturing changes by ensuring supplier readiness, change control execution, and risk mitigation.
Manage supplier quality oversight and compliance with FDA QSR, ISO 13485, and J&J QMS requirements.
Lead and develop supplier quality team, driving accountability, capability building, and performance excellence.
Own supplier audits, CAPA, nonconformance investigations, and quality agreements.
Partner cross-functionally to mitigate supplier risk and support external manufacturing operations.