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Joining us is a chance for you 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, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.

The ideal candidate should demonstrate proficient experience with quality management concepts, IQ/OQ/PQ process validation and manufacturing engineering to drive continuous improvement. The candidate will act as liaison between the organization and the supplier to lead and communicate the component/process validation requirements and ensure timely completion and verification of the activities. The Indvidual must be able to perform each essential duty satisfactorily.

• Responsible for communication, verification and execution of process validations of supplier processes that involve products procured and used by Integra for the Integra Codman Specialty Surgical and Tissue Technologies divisions.

• Ensure supplier Process validation requirements (CTQs, drawings, specifications, FAIs etc.) and protocol for IQ/OQ/PQ are communicated, completed, and verified for each responsible group.

• Drive continuous improvement in supplier quality processes through data analysis and identification of areas for improvement.

• Provide support to Integra sites by leading critical Supplier Quality related issues to determine root cause and drive CAPAs, which may require supplier visits and for-cause audits to evaluate supplier's manufacturing processes.

• Review and approve executed qualification documentation (IQ/OQ/PQ) with suppliers for new product and LCM projects.

• Develop and promote the right behaviors to sustain a culture of continuous improvement necessary to support both short- and long-term business objectives.

• Directly supervise employees in the GSQ group.

• Support the integration of newly acquired businesses and supplier consolidation initiative.

• Provide and develop training on the Process Validation concepts to the team and organization, as needed.

• Utilize coaching and facilitating skills with program shareholders to ensure proper project management, expectation setting, and best practices are utilized.

• Carry out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

• 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, 21 CFR Part 11 & IQ/OQ/PQ.

• 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

The requirements listed below are representative of the knowledge, skill, and experience required for this position.

• Bachelor’s or master's degree in manufacturing engineering, Mechanical Engineering, Industrial Engineering or Sciences.

• Minimum 12-years of experience in quality or manufacturing with bachelor’s degree or 10 years with master’s degree.

• Minimum 6 years of people management experience.

• Strong experience in process validation and component qualification - IQ/OQ/PQ and data analytics

• Medical Device or Pharmaceutical experience is required.

• Experience or knowledge of ISO 9001 and ISO 13485 requirements preferred.

• Travel up to 25% with a possibility of international travel.

• Experience in FDA and other regulatory 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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