Quality Control Inspector I

MAIN PURPOSE OF THE ROLE

The **Quality Control Inspector I** performs inspection and testing of purchased materials, components and products in accordance with policy and procedures

MAIN RESPONSIBILITIES

• 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.
• Recommends changes to policies and procedures.
• Documents non-conformances in Non-Conforming Material Review system.
• 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.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

QUALIFICATIONS

Education

• High School Diploma / GED or an equivalent combination of education and work experience

Experience/Background

• Experience - Some - 0-2 year’s related work experience.
• Previous experience in Quality performing inspection.
• Prior medical device component inspection experience preferred.
• Experience with 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 Microsoft Word and Excel.
• ASQ CMI certification preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• 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.
• 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.