Integra LifeSciences Quality Engineer III in Mansfield, Massachusetts
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 4,400 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."
It's a great time to join our growing company and become one of our impassioned colleagues making lives better for the patients we serve!
The Senior Life Cycle Management (LCM) Quality Engineer will work within the Integra Lifesciences CSS Quality organization to support design changes and improvements on our range of Neurosurgical Medical Devices.
Working within the LCM Design Quality team, you should excel in an environment that embraces teamwork, change, risk-based decision making and flexibility. You should be willing to make a significant contribution to a multi-discipline team, must be self-motivated to take actions, and have excellent written and verbal communication skills. The position will support improvements of existing products as part of the design change process, support supply chain concerns as well as design related aspects of product and process transfers between manufacturing sites. This position will have responsibility for executing base business design change projects to ensure the highest levels of product quality to the end customer. Being able to independently plan and conduct projects and/or assignments with technical responsibilities or strategic inputs with moderately detailed instructions from Leaders and Stakeholders is a must-have.
Lead and/or support design changes and improvements to Medical devices in close collaboration with R&D and external partners
Lead and/or support risk analysis activities. Demonstrate proficiency in applying various risk management and risk mitigation tools and practices (for example, mistake proofing, critical control points, failure mode effects analysis).
Apply statistical methods and process/design excellence tools to establish validation and test plans as well as evaluate test data and processes.
Proficiency in Design / Process Verification and Validation, GR&R, Statistical Sampling Plan techniques, and Statistical Process Control
Conducts, and supports the development of test methods, process validation / verification, and product validation / verification.
Support transfer to manufacturing activities both in product development and base business
Contributes to root cause investigations using various problem-solving techniques and tools, and assesses effectiveness of corrective actions.
Develop inspection methodology and acceptance criteria for sampling plans
Provide leadership in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Risk Management, Complaints, Post Market Surveillance, Nonconforming Materials, etc.
Support supply chain issue resolution / product investigations for our base business products
Fulfill design change control requirements in accordance with company procedures, FDA and ISO guidelines
Communicate effectively at all levels within Quality, as well as cross functionally with departments such as Research & Development, Regulatory, Marketing and Manufacturing
Demonstrate project management and leadership abilities
Bachelor’s degree (or equivalent) in Engineering or related technical/scientific field with a minimum of 4 years of related experience.
Experience in medical device product development / process and product validation
Knowledge of Quality Engineering/Scientific methods and techniques.
Experience managing projects and demonstrating leadership abilities.
Strong analytical and statistical skills
Six Sigma certification preferred
Knowledge of Standards and regulations: ISO 9000, ISO 13485, ISO 14971, and CFR 820 is preferred
Vacancy ID 2018-26768
Position Type Regular Full-Time
Category Quality Assurance