Global Supplier Quality Engineer II

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.

About the role

The Global Supplier Quality Engineer II will play a vital role supporting Supplier Quality by conducting supplier audits and maintaining supplier quality requirements for Integra's manufacturing site in Columbia, MD. This individual will provide quality assurance leadership to select contract manufacturing sites and raw material suppliers engaged in the production of Integra products.

Responsibilities

• Establishes and ensures the Approved Supplier List is up to date
• Establishes timely planning and execution of supplier audits
• Conducts Supplier Audits according to good manufacturing practices, ISO Standards, and applicable regulatory requirements
• Ensures comprehensive measurement systems in place to monitor supplier quality/reliability, and to identify, correct and prevent defects
• Establish and ensure Supplier Quality Agreements are up to date for applicable suppliers engaged in the production of Integra products
• Ensure technical support to QC, purchasing, and production departments
• Provide Quality Engineering Support to suppliers including audits/assessments, inspection technique support, verification/validation activities, CAPA, and change management (FDA CFR part 820 and ISO 13485 regulations/standards will be the focus)
• Addresses Supplier Change Requests in compliance with procedures and regulatory requirements
• Ensures that activities for validation of outsourced processes/products are performed and documented according to procedures and within the defined timeline
• Ensures that Supplier Non-conformances are initiated, dispositioned, approved, and investigated according to plans and in compliance with procedures and regulatory requirements
• Escalate supplier quality issues to management as appropriate, develop and propose robust and compliant solutions
• Participates in and leads continuous improvement projects and initiatives
• Participates and supports internal and third-party audits/inspections
• Manages or participates in quality projects as required
• Provides support with complaint investigations as required
• Leads quarterly Supplier Management Meetings for the Columbia site
• Provides support for external and regulatory audits

Requirements

• Bachelor’s or master's degree in manufacturing engineering, mechanical engineering, industrial engineering, or sciences or a related discipline is required
• Minimum 3 years of experience in quality or manufacturing
• Medical Device or Pharmaceutical experience is required
• Experience or knowledge of ISO 9001 and ISO 13485, 21 CFR 820, requirements preferred
• Travel up to 25% with a possibility of international travel
• Experience in FDA and other regulatory controlled environments
• Strong collaboration skills and experience working in a matrix environment
• Ability to read and understand technical and statistical documents
• Ability to interface with technical and non-technical personnel
• Knowledge of current Good Manufacturing Practices (cGMP) and other applicable standards
• Experience using analytical tools to drive data-based decision making

Pay

Salary Pay Range: $71,300.00 - $97,750.00 USD. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity, or other variable compensation.

Benefits

• Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance
• Savings plan (401(k))