Summary: Support maintenance of quality system requirements, including: external, internal and supplier audits, CAPA, quality metrics reporting, management review preparation, and training.
Applies quality engineering principles to address product and process issues, ensure reliable new and/or changed product development, lead investigations, and provide general support of the quality system. Works on a wide range of quality problems related to Quality Systems, Product Quality, and Supplier Management. Experience working with software-driven electro mechanical medical devices strongly desired.
Essential Duties and Responsibilities:
1.Establish and update quality system procedures in compliance with requirements for medical devices
2.Process owner for internal auditing system, process audit program, and/or CAPA system.
3.Assists the Supplier Quality Management activities by conducting Operations and Quality audits for subcontract manufacturers and critical component suppliers
4.Supports/manages external audits and regulatory inspections.
5.Support/maintenance of technical files, MDD certification and declarations of conformity in support of EU product registrations/CE mark.
6.Prepare metrics in support of trending and management review.
7 Supports Quality Assurance, Quality Control, and Regulatory functions as necessary.
8.Assist with process improvement programs.
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
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 years of quality systems experience in an electro-mechanical medical device company.
Current knowledge of FDA and international quality system requirements are a must. Direct experience managing an internal audit system or CAPA system strongly preferred.
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.
Certificates, Licenses, Registrations: Certification by ASQ as certified quality auditor (CQA) and/or quality engineer (CQE) preferred.
Natus Medical Incorporated