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.

This position is for a Sr. Supplier Quality Engineer l - Global Supplier Quality with hands-on experience and proven success in managing Supplier Quality system while supporting and leading strategic initiatives to build a robust supplier quality system for the organization.

Responsibilities :

• Provide support to sites by leading critical Supplier Quality related projects and issues which may 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 with suppliers based on the established criteria and metrics.
• Build relationships with internal and external partners and influence external manufacturers to continuously improve processes and procedures.
• Participate in Quality Management Reviews and monthly Quality Forums.
• 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.
• Integrate / participate in the overall quality / operation / division leadership community by sharing and seeking best practices and methodologies and finding new ways to help drive for maximizing performance.
• Implement and sustain continuous improvement practices and culture throughout the organization.
• Provide 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. Influence and collaborate across stakeholder groups in the areas of process / continuous improvements, identify and implement opportunities.

Qualifications :

Equal Opportunity Employer : Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

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