Summary: Manages the Corporate Quality Management System (QMS) internal audit program.
Essential duties and responsibilities are not limited to the following;
Ensures that all direct reports are familiar with, trained on and follow all Quality System procedures related to their jobs which can affect the quality of products or services provided to our customers and that changes to procedures are reviewed, approved and validated prior to implementation
Manages an annual internal audit program sufficient in scope to meet the Corporate Quality System requirements of Executive Management
Applies a risk-based approach to the audit of the company’s QMS activities based on internal quality audit risk assessment, as well as strategic, operational, and regulatory compliance priorities
Plans, schedules, and executes QMS internal audit program encompassing all company locations
Communicates results of QMS internal audits and status of remediation activities
Prepares reports and other information for presentation to Executive Management
Directly supervises up to ten employees or contractors
Carries out supervisory responsibilities in accordance with the Natus policies and applicable laws
Responsibilities include interviewing, hiring and training employees; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
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.
Bachelor's degree from four-year college or university
Quality Management Systems Internal Auditor Certifications
8+ years of experience auditing Quality Management Systems in medical device companies
Working knowledge of U.S. FDA, ISO and MDD quality system and regulatory requirements associated with the development, production and registration of products in the medical device industry
Experience with electro-mechanical, software, and disposable medical devices is preferred
Ability to read, analyze and interpret common scientific and technical journals, financial reports and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agency or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format. Ability to effectively present information to top management, public groups and/or boards of directors.
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.
Certificates, Licenses, Registrations:
Required: Certified Quality Auditor
Preferred: Certified Quality Manager
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. Specific vision abilities required by this job include (close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus).
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.