Job Information
Integra LifeSciences Sr. Supplier Quality Engineer in Irvine, California
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 - 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.
The Sr. SQE will support and lead strategic initiatives to build a system and culture resulting in year-on-year quality/process improvements. The ideal candidate should demonstrate proficient experience with quality management concepts and Project Management including but not limited to supplier quality audits, eQMS, risk assessment, process qualification, process controls, root cause investigations, CAPA, and continuous improvement.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
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
Drive continuous improvement in with supplier 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.
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.
DESIRED MINIMUM QUALIFICATIONS:
The requirements listed below are representative of the knowledge, skill, and experience required for this position.
Master's degree in engineering, Computer Science or Sciences.
Minimum 7-years of experience in quality, manufacturing, or engineering.
Strong experience using eQMS software solutions preferred.
Travel up to 30%
Experience in FDA controlled environment.
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.
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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