• Performs visual, dimensional and functional inspection and testing according to documented policies and procedures.
• Records inspection and test data as prescribed by written instructions and procedures.
• Operates all associated test and measurement equipment as instructed and as documented in procedures.
• Assists in the Development of inspection methods.
• Recommends changes to policies and procedures.
• Documents non-conformances in Non-Conforming Material Review system.
• Participates in GR&R studies as directed by engineers or technicians.
• Collects and analyzes data for First Article inspections.
• Performs testing and inspection in accordance with special test requests.
• Contributes to test and measurement equipment selection.
• May assist in training other inspection staff in use of equipment.
• Requests certification from vendors.
• Assists in gathering, analyzing, and trending of data.
• Performs work of a miscellaneous nature as required.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Education Level

• High School Diploma / GED

• 1-2 years’ experience in Quality performing inspection.
• Experience with CMMs, optical measurement equipment, hand tools, gages, pressure and force gage testing.
• Training in blueprint reading and experience with inspection sampling techniques.
• Knowledge of FDA, GMP, ISO 13485.
• Good communication and computer skills, including MS Word, MS Excel, database entry, and use of statistical software packages.
• Prior medical device component inspection experience preferred.
• ASQ CMI certification preferred.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Experience working in a broader enterprise/cross-division business environment.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Must be willing to work overtime as required, including weekends
• Ability to maintain regular and predictable attendance