QMS Specialist Consultant I

posted:
Location
Mt. Pleasant, Pennsylvania
Industry
Manufacturing & Production (Production Occupations)
Job Type
Contract
Salary
US$ 28.00 - US$ 32.00 per hour
Ref. Number
R_PHI4542
Contact
Amy Cornman, Spherion
Phone
724-334-3113
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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.

Skills

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. 

Qualification

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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