Quality Assurance Engineer

Assists the Quality Assurance and Regulatory Affairs Manager in regulatory compliant company-wide quality assurance department that provides all research, support, product development, and quality assurance functions required along with accurate specifications, service, and delivery of product to our customers. Assist the Quality Assurance and Regulatory Affairs Manager in the management of the quality assurance department to support production schedules, personnel, resources and continuous improvement efforts that achieve efficient service productivity.

Assists the Quality Assurance and Regulatory Affairs Manager in the evaluation and controls to vendor reliability of goods and services.

• 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 in industrial engineering, mechanical engineering, or business from an accredited four-year college is preferred. Associate’s degree or equivalent from an accredited two-year college/technical school, or higher will be considered, plus 2-4 years of quality assurance engineering experience in a medical device manufacturing environment; or equivalent combination of education and experience. Experience in Plastic Injection and/or Blow Molding is desired.
• Must have working knowledge of the FDA 21 CFR Part 820 Quality System Regulation.
• Working knowledge of ISO 13485:2016 Standard is preferred.
• Current certified ISO 13485:2016 Lead Auditor certificate is preferred.