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Quality Systems and Integration Engineer
Maple Grove, MN
1 Year Contract
This position will assist with day to day execution, and integration, of a newly acquired medical device company with the new parent company.
This person will provide leadership and project management skills to plan, organize, and execute activities required to ensure the newly acquired company meets the quality system requirements of both federal and regulatory standards, as well as corporate procedures.
This person will help to integrate the quality system procedures, processes, and systems between the acquired company and the parent company.
This person will collaborate with cross-functional teams to support the overall integration effort.
This person will communicate progress of quality integration efforts and quality system compliance risks.
Perform gap assessments between the two quality systems and ensure timely corrective and preventive actions to address any remediation efforts that are required as the result of gaps found.
Support internal and external audits
Support day to day execution of CAPA and Non-Conformance processes.
Support day to day document control management
Support day to day training system execution
Other responsibilities may be assigned and not all responsibilities listed may be assigned.
• A BS Degree in technical science or engineering or BA in business, quality is required.
• A minimum of 4 years of related experience is required, preferably in a regulated industry
• Personal computer skills, Windows: word processing, project planning, presentation, e-mail and spreadsheet software
• Experience in audits (either as auditor or auditee) to ISO standards for QMS, MDD, FDA QSR and CMDR, required.
• Experience with quality systems is required.
• Experience in the management of document control, CAPA, Non-Conformance, and training processes preferred
• General knowledge of medical devices regulatory requirements is necessary. Experience in the medical devices or pharmaceutical industry is preferred. Possess a demonstrated track record of achieving successful compliance.
• Proven success in: Accountability, with a strong desire to commit, and be held accountable for delivering results.
• Must have strong collaboration skills to partner effectively with Operating Company functions and across Operating Units. Proven track record of demonstrating collaboration across organizations at multiple levels
• Strong analytical skills and experience
• Change management and project management experience
• Communication – demonstrate the ability to discuss complex quality issues and concepts in a clear and concise manner, orally and in writing - with all levels of management
• Detail oriented
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Axelon Services, Corp is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, gender identity, national origin, disability, or protected veteran status.