This is a 1 year contract opportunity and will be based out of a third-party site at Pioneer.

Primary Function:

• Working under minimal supervision, performs inspection and testing of purchased materials, components and products in accordance with policy and procedures.

Major 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.
• Operates all associated test and measurement equipment as instructed and as documented in procedures.
• Documents non-conformances in Non-Conforming Material Review system.
• Assists in gathering, analyzing, and trending of data.
• Completes and maintains certification/cross-training for all related QA inspection operations.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Supports all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Requirements:

• Diploma in Science/ Engineering or related discipline
• Minimum 2-3 years experience in Quality function, performing inspection, preferably in medical device manufacturing or warehouse operations.
• Knowledge of FDA and Good Manufacturing Practices 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.
• Ability to multitask, prioritize and meet deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.