Integra LifeSciences Manager, Quality Assurance Training in Plainsboro, New Jersey
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 4,500 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."
Develop and maintain quality system training requirements, including identification of external training/qualifications as necessary by function (e.g. professional organizations or accreditation programs; such RAB, ASQ, RAC).
Design education programs for general QA/RA training and specific elements of Quality Systems and Regulatory Compliance.
Identify and manage external resource(s) to support training and education curricula development as required.
Identify best practices and process improvements for training identification, implementation, completion, and methods for evaluating training effectiveness.
Develop and implement improved processes. Identify opportunities to streamline and further automate software/systems solutions.
Evaluate training curricula for sites and assist site personnel with the implementation of training programs and documentation practices.
Provide quarterly Management Review updates on the state of the Training and Education programs. Communicate expectations regarding training quality metrics and scores to all stakeholders and employees.
Bachelors degree in Science or Education; Masters degree preferred
7- 10 years experience in quality assurance or regulatory compliance in FDA regulated field
Minimum of 4 years experience in quality assurance training
Minimum of 3 years experience using automate software training solutions
Strong Medical Device background preferred
Experienced with evaluation, implementation and oversight of internal and external training programs
Knowledge of FDA regulations, ISO Standards and MOD laws/regulations
Excellent communication skills; experience facilitating training program required
Experience in Documentation Control and metrics analysis
Proficient in the use of Microsoft Office
Ability and willingness to travel
Vacancy ID 2018-26699
Position Type Regular Full-Time
Category Quality Assurance