Quality Assurance Engineer
Senior Quality Assurance Specialist

Quality Assurance Engineer - (Location - Youngsville, NC ) This position is responsible for ensuring that the standards of ISO 9001 Quality System are maintained in production; providing support in the design, development and improvement of manufacturing processes; preparing validation protocols and reports; managing protocol execution; and initialing quality system process improvements. The QA Engineer will participate on the ISO Internal Audit Team. Requirements include a minimum of a Bachelor’s degree and 5+ years’ experience in a FDA/ISO-regulated environment or an Associate’s Degree and 6 years’ experience in a quality assurance role. Candidates with certification preferred. Ability to gain support of other teams/groups not under your direct supervision is a must. Excellent written and verbal communication skills are necessary. Experience in medical/pharmaceutical manufacturing is a plus. Local candidate preferred. Human Resource Manager (919)570-9611 fax OR Apogee Medical LLC 90 Weathers Street Youngsville, NC 27596 NO AGENCIES PLEASE

Senior Quality Assurance Specialist - (Location - Youngsville, NC) Responsibilities include performances of visual and function testing of disposable medical devices; review of manufacturing documentation; service on ISO Internal Audit Team; and performance of other QA duties. 3-5 years of solid quality experience preferred. Candidates should possess the ability to disposition finished product through analysis and judge product acceptability in comparison to specification. Knowledge in using and operating typical measuring devices, calibration and documentation control. Although this is not a management position, ability to work independently and make judgment calls based on GMP and manufacturing documentation will be a required skill. Strong math skills and excellent verbal and communication skills are required. (Additionally, candidate should have a good understanding of general quality practices. ISO 9001 & 13485 requirements. Clean Room requirements. CAPA , and Nonconforming Material Handling. Basic computer skills are necessary; the ability to update/modify and maintain QMS documentation a plus. Human Resources Manager (919)570-9611 fax OR Apogee Medical LLC 90 Weathers Street Youngsville, NC 27596 NO AGENCIES PLEASE