Analyst, Quality

MAIN RESPONSIBILITIES

• Internal liaison and expert for quality metric database development, maintenance, and sustainment activities.
• Partner with cross-functional Quality and Business Unit Teams to fulfill reporting requirements. Includes, but not limited to: nonconformance/Corrective Action and Preventative Action (CAPA) trending and summaries; FDA Medical Device Reporting trending and summaries; EU Medical Device Vigilance reporting trending and summaries; and Weekly, monthly, and quarterly product line complaints reporting.
• Support internal and external audits by preparing and providing relevant reports and analysis.
• 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.
• Performs other related duties and responsibilities, on occasion, as assigned.

MINIMUM Requirements

• Minimum 1-2 years in a manufacturing environment, medical Device experience preferred.
• Bachelors Degree ( 16 years) OR an equivalent combination of education and work experience.
• Ability to manage multiple tasks and priorities. Strong Microsoft Office capabilities required.
• Experience working in a broader enterprise/cross-division business unit model preferred. 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. Strong organizational and follow-up skills, as well as attention to detail.