Overview Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, reconstructive and general surgery, and regenerative wound care. Integra's orthopedic products include devices and implants for foot and ankle, hand and wrist, shoulder and elbow, tendon and peripheral nerve protection and repair. Integra is a leader in neurosurgery, offering a broad portfolio of implants, devices, instruments and systems used in neurosurgery, neuromonitoring, neurotrauma, and related critical care. Integra's Tissue Technologies is an in-patient and outpatient Regenerative product portfolio, which includes products for wound care, burns, abdominal reconstruction, and plastic & reconstructive surgery. In the United States, Integra is a leading provider of surgical instruments to hospitals, surgery centers and alternate care sites, including physician and dental offices. Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has over 3,300 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART." Responsibilities Provide quality compliance support for the following tasks and duties: Support process related projects including validation activities. Create and/or maintain risk management documents. Complete or support process related Events or NC investigations. Facilitate launching of new or improved products and processes into manufacturing areas. Participate in problem solving teams. Evaluate process quality related trends and identification and implementation of corrective actions. Facilitate the development, implementation, and monitoring of quality programs and policies that ensure the manufacturing and distribution of medical products is in compliance with corporate policies, U.S. Food and Drug Administration regulations, ISO, the Medical Device Directive and other applicable regulatory agencies. ESSENTIAL DUTIES AND RESPONSIBILITIES:To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.1. Works with Manufacturing Process Engineers to create and maintain process flows, pFMEAs and process MVP.2. Develop statistically based sampling plans for in process and final testing inspections.3. Evaluate process quality related trends; identification and implementation of corrective actions, as required.4. Develop, implement and maintain SPC systems for assigned areas of responsibility.5. Support process improvement projects and initiatives (i.e., scrap reduction initiatives, capacity increase, cost improvement, etc.).6. Support process related NC and Complaints investigations, as required.7. Support in the investigation and resolution of supplier quality issues.8. Support process validation activities by means of providing quality guidance thru review and approval of validation protocols and reports for new and existing products, processes and equipment. Assure sampling plan justification is based on statistical rationale. Provide statistical analysis of the data to support the reports, as needed.9. Prepare and execute QA related validation protocols. Develop or update Quality System documents, as required. 10. Work with project teams (internal/external departments) to develop Design of Experiments (DOE's) and statistically sound tests for appropriate support of results.11. Ensure that all projects, including appropriate documentation, are generated in compliance with Integra's procedures, cGMP requirements and statutory requirements (US FDA, ISO, MDD and CMDR).12. Develop quality system metrics to support Quality Management Reviews, among others.13. Provide Change Control QA requirements for process related changes.14. NC process owner for area of responsibility ensuring proper documentation and adequate containment. Complete assigned Events, Non-Conformance/CAPA investigations, and Action Plans.15. Quality problem resolution by means of Root Cause/Problem Solving Analysis. Implementation of corrective and preventive actions for process related concerns.16. Participates in FDA inspections, ISO Certification and surveillance audits and customer audits as required.17. Perform other related duties as required. Qualifications The requirements listed below are representative of the knowledge, skill, and/or ability required for this position. Any equivalent combination of education and experience that provides the applicant with the knowledge, skills, and abilities to perform the job is acceptable. Education Bachelors is required. Chemical, Biomedical, Mechanical, or Industrial Engineering is preferred. Experience: 3 to 5 years minimum experience in an FDA regulated environment, preferably in Quality Assurance.ASQ Certified Quality Engineer (CQE), preferred.Experience with Quality System Regulation (QSR), ISO, Design Control and Process Validation guidelines.Able to develop technical documentation (technical writing) such as: Validation Protocols, Technical / investigation reports, SOP, Validation Plans, Change Controls, and others.Will have a fundamental understanding of a quality system and its development, documentation and implementation to domestic and international standards or requirements.Will be able to develop and implement quality programs, including tracking, analyzing, reporting, problem solving, and analytical thinking. Will be able to plan, control and assure product and process quality in accordance with quality principles.Will have basic knowledge of reliability, maintainability, and risk management, including key terms and definitions, assessment tools and reporting.Will be able to acquire and analyze data using appropriate standard quantitative methods across a spectrum of business environments to facilitate process analysis and improvements.Strong Project Management skillsKnowledge in Lean and Six Sigma conceptsKnowledge of statistical techniques: SPC, DOE, Process Capability and Gage R & R, etc.Use of statistical process Minitab tools is preferred. SDL2017
