Integra LifeSciences Jobs

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The Senior Manager of Global Supplier Quality will be responsible for Supplier Quality activities within the Tissue Technologies division, supervising staff across multiple TT sites and supporting other business activities as needed. The individual is expected to have hands-on experience and proven success in developing and managing Supplier Quality processes while supporting quality leadership to drive strategic initiatives.

To perform this job successfully, an individual must be able to perform each of the following duties satisfactorily:

• Responsible for Supplier Quality activities across multiple Integra manufacturing sites, supervising staff across multiple locations

• Serves as a key point of contact to Quality and Supply Chain partners for Supplier Quality issues, and liaises with the Integra organization to drive timely resolution of Supplier Quality related issues.

• Plan, coordinate, and conduct supplier audits for due diligence, qualification, or cause.

• Identifies opportunities to continuously improve quality, compliance, cost and time factors, consistent with Integra business objectives; identifies significant business issues, prioritizes for action, and leads improvement opportunities and problem solutions.

• Plans, coordinates, and directs quality and compliance programs designed to ensure effective and consistent supplier processes with established standards.

• The position plays a key role in oversight, development, and approval of process validations at supplier sites.

• The Sr. Manager is responsible for management of Supplier Related CAPA, NC, Audit Observation resolution and metrics reporting.

• Support the integration of newly acquired businesses.

• 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.

• Additionally, the individual is responsible for carrying out some managerial responsibilities in accordance with the organization's policies and applicable laws; including interviewing and training employees, planning, assigning, and directing work; appraising performance; addressing complaints; and resolving problems

• Ensure all Quality records are appropriately filed and easily retrievable in the Quality department.

• Participate in Quality Management Reviews and monthly Quality Forums.

• Collect and analyze performance data against defined parameters.

• Provide leadership and guidance in the areas of CAPA, non-conformances, Product complaints, and document control.

• Perform other related duties as expected.

Qualifications:

• Bachelors or master’s degree in engineering, Computer Science or Sciences.

• Minimum 10-years of experience in quality, manufacturing, or engineering.

• Minimum 5 years of people management experience.

• Experience working in a Medical Device manufacturing environment is preferred.

• Operations supplier quality experience, with a strong understanding of process validation highly desired

• Minimum 5 years of professional work experience in a GMP and /or ISO regulated industry is required

• Knowledge of Medical device standards and regulations such as ISO13485, 93/42 EEC, 21 CFR part 820

• Strong communication, teamwork, and organizational skills are a must

• Strong analytical problem solving and root cause analysis skills

• Auditing background is preferred

• Use of Microsoft office tools

• Knowledge of statistical techniques

• Experience or knowledge with the machining processes, injection molding, and/or electro-mechanical components/assembly is preferred

• Willing to travel (internationally)

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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