SUMMARY: Support maintenance of quality system requirements, including: Nonconforming product and Material Review Board, external, internal and supplier audits, CAPA, quality metrics reporting, management review preparation, and training.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Establish and update quality system procedures in compliance with requirements for medical devices
Plan and conduct quality system audits in accordance with documented procedures.
Provides oversight for the Receiving Inspection Team
Process owner for inspection process, calibration process, and Material Review Board (NCR/MRB) processes.
Oversees the management of the Calibration and Maintenance systems
Manages the Material Review Board meetings
Support Supplier Quality
Supports/manages external audits, regulatory inspections and safety agency audits
Process and/or action owner for corrective and preventive action system (CAPA).
Prepare metrics in support of trending and management review.
Provides general support of the quality system
QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
Travel Required: minimal to moderate
Supervisory responsibilities: 0-5 people
Education and/or Experience:
Bachelor's degree (B.S.) from a four-year college or university in the sciences or related field, with a minimum of 5-7 years of experience in Quality or Regulatory.
Some supervisory experience preferred
Current knowledge of FDA and international quality system requirements.
Specific experience overseeing nonconforming materials and MRB.
Experience in an electro-medical device company strongly preferred.
Experience following Device Design Controls and Risk Management Processes preferred.
Direct experience managing FDA and other agency audits preferred.
Other Skills and Abilities:
The Food and Drug Administration’s Quality System Regulations (FDA’s QSR)
International standards such as ISO 13485, ISO 14971
Founded in 1989, Natus Medical Incorporated is a leading manufacturer of medical devices and software and a service provider for the Newborn Care, Neurology, Sleep, Hearing and Balance markets. Natus products are used in hospitals, clinics and laboratories worldwide. Our mission is to improve outcomes and patient care in target markets through innovative screening, diagnostic and treatment solutio...ns.
Products manufactured by Natus are sold through a combination of a direct sales force and worldwide distribution partners. Natus products are sold and supported in over 100 countries. Among the many benefits provided to our customers is the NERVE Center, Natus’ education portal supporting our customers with ongoing product and clinical training and education.
ASM International is the world's largest association of metals-centric materials engineers and scientists. We are dedicated to informing, educating, and connecting the materials community to solve problems and stimulate innovation around the world.
ASM World Headquarters 9639 Kinsman Road Materials Park, OH 44073-0002