QMS Specialist Consultant I

Mt. Pleasant, Pennsylvania
Manufacturing & Production (Production Occupations)
Job Type
US$ 28.00 - US$ 32.00 per hour
Ref. Number
Amy Cornman, Spherion
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Job Description

 Job requirements: Demonstrated capability and experience in role. Provide quality management system support for distribution, customer service, and service functions. Job responsibilities to include but not limited to: • Write, review, and approve procedures ensuring compliance with applicable standards and regulations • Assist in the development of departmental metrics and conduct any necessary validation to meet quality system requirements. • Analyzing customer satisfaction data, gathering additional data as needed. Review and apply appropriate coding and be responsible for timely closure of records to meet departmental KPIs. • Support and lead the implementation of continuous improvement initiatives • Participate on special projects as assigned by Manager by functioning as the QA representative and responsible for providing regular status updates to manager and team • Review of nonconforming material records providing quality system approval • Capable of conducting gap analysis of quality system processes to the regulations and facilitating the closure of any identified gaps.


Demonstrated ability of planning and organizing, customer focus, and cross-functional/teamwork skills. • Excellent verbal/written communications, as well as a strong attention to detail required. Ability to communicate effectively within the team. • Strong use of of MS Office Applications. 


Experience: Minimum3 years experience in the medical device industry with knowledge and experience in quality systems and quality improvement. Knowledge of FDA Quality System Regulations, MDSAP, and ISO 13485 standards. •

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