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
Supports Quality Assurance and Quality Control functions as necessary.
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
Medical Devices Directive (MDD)
Microsoft Excel and Word
Statistical analysis of quality data
Ability to read, analyze and interpret general business periodicals, professional journals and technical
procedures. Ability to write reports, business correspondence and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers and the general public.
Ability to work with mathematical concepts such as probability and statistical inference and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations.
Ability to solve practical problems and deal with a variety of concrete variables, in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form. Ability to resolve complex systems problems and identify solutions to obstacles encountered while resolving problems.
Certificates, Licenses, Registrations:
Certification by ASQ as certified quality auditor (CQA), quality engineer (CQE), or equivalent strongly preferred.
PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is regularly required to work at a keyboard and computer. Specific vision abilities required by this job include close vision and the ability to adjust focus. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds.
WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually moderate.
Natus Medical is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, veteran status, disability, sexual orientation, gender identity, or any other protected status
Additional Salary Information: Natus offers competitive salaries, comprehensive benefit package that starts on your 1st day, 401k match, an employee stock purchase plan, 9 paid holidays, generous paid time off plan (4 weeks to start) and tuition reimbursement up to $5,000 annually
Natus is a leading provider of healthcare products and services used for the screening, detection, treatment, monitoring and tracking of common medical ailments in neurological dysfunction, epilepsy, sleep disorders, newborn care, hearing impairment and balance and mobility disorders.