Staff Quality Engineer

This position is for a Staff Engineer - Supplier Quality Validation Engineer with hands-on experience and proven success in Process Validation and driving cont. improvement with suppliers.  This position will be primarily engaged to ensure timely completion of process validation requirements of new products and life cycle change management (LCM) projects with suppliers to the required quality standard in accordance with defined program and company requirements. 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. 

RESPONSIBILITIES

• 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.

• Perform for-cause audits to determine root cause and drive CAPAs while supporting the site supplier quality teams.

• Provide support to sites by leading critical Supplier Quality related issues which may require supplier visits and audits.

• 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.

• Support the 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.

• 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

• Bachelor's degree or equivalent with 10+ years of experience, master's degree with 8+ years of experience, Doctoral degree with 5+ years of experience in manufacturing engineering, Mechanical Engineering, Industrial Engineering, Quality or relevant engineering degree. 

• Fluent in English with strong communication skills

• 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 10% 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.