Senior Supplier Quality Engineer I

Integra LifeSciences • Plainsboro Township, NJ

7d

About The Position

The Senior Supplier Quality Engineer I supports Supplier Quality for Integra’s new manufacturing site in Plainsboro, New Jersey. The role manages the Supplier Quality system and supports and leads strategic initiatives to build a robust supplier quality system. It calls for experience in supplier quality audits, eQMS, risk assessment, process qualification and controls, root-cause investigations, CAPA, and continuous improvement. The position also provides strategic direction and communication of company goals, directives, and policies to subordinates, and directs Global Supplier Quality department activities to ensure compliance with applicable regulations and standards.

Requirements

• Bachelor’s degree with at least 5 years of supplier quality experience, or a master’s degree with at least 3 years of supplier quality experience, or equivalent education and years of experience.
• At least 5 years of experience in supplier auditing.
• Experience in an FDA-controlled environment.
• Strong collaboration skills and experience working in a matrix environment.
• Ability to read and understand technical and statistical documents.
• Knowledge of current Good Manufacturing Practices (cGMP) and other applicable standards.
• Experience using analytical tools to support data-based decision-making.
• Ability to travel up to 50%.

Nice To Haves

• Lead auditor certification and/or CQA/CQE.
• ISO 13485 Certified Auditor certification.
• Experience using eQMS software solutions.

Responsibilities

• Support the Integra Plainsboro facility by leading critical Supplier Quality projects and issues, including supplier visits and audits.
• Coordinate and facilitate periodic quality reviews and support business reviews with key suppliers.
• Work with suppliers to resolve quality issues by issuing and monitoring Supplier Corrective Action Requests (SCARs).
• Drive supplier continuous improvement based on established criteria and metrics.
• Participate in quarterly Quality Management Reviews.
• Collect and analyze performance data against defined parameters.
• Lead identification and resolution of quality issues and complaints, including facilitating investigations and developing robust CAPA plans.
• Support integration of newly acquired businesses.
• Implement and sustain continuous improvement practices and culture throughout the organization.
• Provide strategic direction and communicate company goals, directives, and policies to subordinates, fostering a clear vision and positive, team-oriented environment.
• Direct Global Supplier Quality department activities to ensure compliance with applicable regulations and standards, including FDA, ISO 13485, CMDR, MDR, JPAL, and 21 CFR Part 11.
• Coordinate activities with other departments, external vendors, and customers.
• Collaborate across stakeholder groups on process and continuous improvement, and identify and implement opportunities.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Life insurance
• Short- and long-term disability insurance
• Business accident insurance
• Group legal insurance
• 401(k) savings plan
• Employees may be eligible for bonus, commission, equity, or other variable compensation, subject to applicable plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior