Global Supplier Quality Engineer II

Changing lives and building careers, this role offers the opportunity to do important work that creates change and shapes the future of healthcare. Join a team that thrives on thinking differently and sees change as opportunity.

About the role

This Global Supplier Quality Engineer II position supports Supplier Quality by conducting supplier audits and maintaining supplier quality requirements for Integra's manufacturing site in Plainsboro, NJ. The role provides quality assurance leadership to select contract manufacturing sites and raw material suppliers engaged in the production of Integra products. This is a hybrid position requiring onsite presence at least 3 days per week in Plainsboro, NJ.

Responsibilities

• Establish and maintain the Approved Supplier List.
• Plan and execute supplier audits in a timely manner.
• Conduct Supplier Audits according to good manufacturing practices, ISO Standards, and applicable regulatory requirements.
• Ensure comprehensive measurement systems are in place to monitor supplier quality and reliability, identifying, correcting, and preventing defects.
• Establish and maintain Supplier Quality Agreements for applicable suppliers engaged in the production of Integra products.
• Provide technical support to QC, purchasing, and production departments.
• Offer Quality Engineering Support to suppliers, including audits/assessments, inspection technique support, verification/validation activities, CAPA, and change management, with a focus on FDA CFR part 820 and ISO 13485 regulations/standards.
• Address Supplier Change Requests in compliance with procedures and regulatory requirements.
• Ensure validation activities for outsourced processes/products are performed and documented according to procedures and within defined timelines.
• Ensure 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, developing and proposing robust and compliant solutions.
• Participate in and lead continuous improvement projects and initiatives.
• Support internal and third-party audits/inspections.
• Manage or participate in quality projects as required.
• Provide support with complaint investigations as needed.
• Lead quarterly Supplier Management Meetings for the Columbia site.

Requirements

• Bachelor’s or master's degree in manufacturing engineering, mechanical engineering, industrial engineering, 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, ISO 13485, and 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, and vision insurance.
• Life insurance, short- and long-term disability, and business accident insurance.
• Group legal insurance.
• Savings plan (401(k)).