Integra LifeSciences Quality Engineer I 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 Quality System Engineer will work within the Integra Lifesciences CSS Quality organization to support our compliance to Quality System requirements and our use of various eQMS systems.
Working within the Quality Systems 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 base business as well as franchise level quality event resolutions. This position will have responsibility for maintaining and communicating Quality metrics and supporting record owners to ensure the highest levels of compliance in our Quality System records. This role will help execute QMS integration activities and will act as a liaison between Codman Specialty Surgical and our critical supplier in support of linked QMS activities. Being able to work independently and influence others is a must-have.
Support quality event resolution and documentation in accordance with company procedures and applicable regulations
Improve quality record content compliance and robustness by working closely with record owners and providing guidance
Maintain quality record metrics and implement robust action plans for any missed targets
Support Quality System integration activities as an eQMS expert for how legacy Codman currently uses EtQ (eQMS) and Adaptiv (PLM system)
Help define user needs for "To Be" eQMS solution
Execute User Acceptance Testing (UAT) for "To Be" eQMS solution
Act as a liaison between Codman Specialty Surgical and critical supplier who owns the "As Is" eQMS solutions
Support base business transfer to Mansfield site
Contributes to root cause investigations using various problem-solving techniques and tools, and assesses effectiveness of corrective actions.
Provide leadership and guidance in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Complaints, Non-conformances, Audits, Document Management, Inventory Management etc.
Support supply chain issue resolution / product investigations
Communicate effectively at all levels within Quality, as well as cross-functionally with departments such as Manufacturing, Design Engineering, and Information Systems
Participate in internal and external audits
Bachelor’s degree (or equivalent) in Engineering or related technical/scientific field
Experience in medical device industry
Experience with EtQ, SAP, and Adaptiv is preferred
Knowledge of Standards and regulations: ISO 9000, ISO 13485, ISO 14971, and CFR 820 is preferred
The position is based in Mansfield, MA and may require 10% of domestic and international travel
Vacancy ID 2018-25900
Position Type Regular Full-Time
Category Quality Assurance