Manufacturing Quality Technician
Minnesota, Minneapolis-St. Paul-
Our client, a Global Leader in the Medical Device Industry has an immediate opening for a Manufacturing Quality Technician for a 12 month + Contract. Our client offers results-driven people a place where they can make a difference every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.
Position Description (Principle Duties and Responsibilities)
Under general supervision; this position will support the goals in processing regulatory documents in electronic and hard-copy median; with strict adherence to regulations. As a Manufacturing QA Technician, you will be required to review, manage and facilitate the activities related to the release of finished product and associated components into the market for consumer use. The role will also serve as a support role for MQA daily responsibilities and as a point of contact/liaison and support routine Manufacturing operations.
Essential Duties and Responsibilities:
Participate in projects as they pertain to MQA.
Conduct revisions to procedures and forms as well as document approvals.
Perform origination and owner responsibilities for Nonconformance investigative reports within the TrackWise systems.
Perform documentation activities that adhere to cGMP and GDP.
Provide support to manufacturing through:
o Answering questions on document revisions and errors
o Intervention/overrides as needed with shop floor data collection
o Timely decision making on product quality issues
o Obtaining corrections on documentation errors and providing explanation where required as pertains to cGMP
Maintain various spreadsheets and databases (requires heavy use of Excel, Word, MS Outlook and similar database programs).
Communicate with Warehouse and Manufacturing personnel regarding the release and movement of materials/components.
Communicate with various departments regarding the release status of materials.
Update the release status of materials electronically to indicate acceptance or rejection.
Work with Shipping Warehouse personnel to accept returned products and update release status as required.
Qualifications & Experience:
Medical Device Experience preferred.
AA degree preferred 2-3 years of experience minimum
General knowledge of FDA regulations for drugs and medical devices.
Exceptional organizational and communication skills.
Ability to perform review of documentation with a high level of attention to detail.
Ability to take direction, work independently as well as with a team and be adaptable in an ever-changing environment.
Capability to handle heavy computer use and work in multiple systems.
Proficiency with Microsoft Office (Word, Excel, etc.) required.
Aptitude to multi-task and prioritize work.
Possesses a high level of personal integrity and self-control.
Physical capability to lift 20 pounds
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