Senior Supplier Quality Engineer I

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. Summary The Sr. Supplier Quality Engineer I will play a vital role supporting Supplier Quality for Integra's new state-of-the-art manufacturing site in Plainsboro, NJ. This individual will have proven success in managing Supplier Quality system while supporting and leading strategic initiatives to build a robust supplier quality system for the organization. The ideal candidate should demonstrate proficient experience with quality management concepts including but not limited to supplier quality audits, eQMS, risk assessment, process qualification, process controls, root cause investigations, CAPA, and continuous improvement. Responsibilities Provide support to the Integra Plainsboro facility leading critical Supplier Quality related projects and issues which will require supplier visits and audits. Coordinate and facilitate periodic quality reviews and support business reviews with key suppliers. Work with suppliers to resolve quality related issues by issuing and monitoring SCARs. Drive continuous improvement in with supplier based on the established criteria and metrics. Participate in quarterly Quality Management Reviews. Collect and analyze performance data against defined parameters. Lead the identification and resolution of quality issues and complaints, including facilitation of investigation process and development of robust CAPA plans. Support the integration of newly acquired businesses. Implement and sustain continuous improvement practices and culture throughout the organization. Provides strategic direction and communication of the company’s goals, directives, and policies to subordinates, creating a clear vision and positive, team-oriented environment resulting in the achievement of the company’s goals and increased profitability. Direct the activities of the GSQ department to ensure compliance with all appropriate regulations and standards, including FDA, ISO 13485, CMDR, MDR, JPAL and 21 CFR Part 11. Interact and coordinate activities with other departments, external vendors, and customers. Influences and collaborates across stakeholder groups in the areas of process / continuous improvements, identify and implement opportunities. Qualifications Bachelor's degree with 5+ years of supplier quality experience OR Master's degree with 3+ years of supplier quality experience OR equivalent education and years of experience. Lead auditor certification and/or CQA/CQE is highly desired. Minimum 5 years of experience in supplier auditing. Experience in FDA controlled environment. Strong collaboration skills and experience working in a matrix environment. Ability to read and understand technical and statistical documents. Travel up to 50%. ISO 13485 Certified Auditor preferred. Experience using eQMS software solutions preferred. Knowledge of current Good Manufacturing Practices (cGMP) and other applicable standards. Experience using analytical tools to drive data-based decision making. Salary Pay Range: Our salary ranges are determined by role, level, and location. 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 . Your recruiter can share more about the specific salary range for your preferred location during the hiring process. Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental,…

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