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Quality Engineer

Location: PA
Industry: Medical Device
Job Code: 12024-11

Participates in formulating quality standards, policies, programs, plans, procedures, and practices. Performs semi-complex statistical analysis as related to quality. Supports in the analysis of production limitations and problems for continuous improvement opportunities. Participates in the implementation of Quality Mgmt Systems and Techniques, (QMST). Conducts semi-complex audits and/or surveys to determine acceptability of quality controls.

Responsibilities:

o Ensure compliance with Food and Drug Administration (FDA) Regulation 21 CFR part 803/806/820 with regards to the handling and implementation of complaints as the regulations relate to company.
o Supports Business Units (BUs) in the processing of complaints, filing of Medical Device Reportings (MDRs), correspondence with FDA on recalls and the screening of service reports.
o Responsible for processing and documentation of reporting and non-reporting rationales on performance and safety complaints for assigned modalities and review of safety issues for potential filing of MDRs to FDA.
o Responsible for preparing all initial, monthly follow up, and closing reports to the FDA for Corrections and Removals per 21 CFR 806 within required deadlines.
o Assist with closing reports, information requests, closing feedback and acknowledgements of complaints.
o Establish and maintain communication between Regulatory Affairs. UPTIME Service Center and field organizations, and the respective Business Unit/Designated Complaint Unit (BU/DCU) in Germany and other manufacturing facilities both outside and within the organization in order to update and close active files.
o Assist in internal/external audits where applicable.

Requirements:

o Bachelors degree or equivalent with a minimum of 2-4 years direct Complaint/MDR reporting experience.
o Knowledge of the FDA 21 CFR part 803/806/820 regulations a must.
o Ability to work independently and in groups.
o Must have excellent organizational, interpersonal and communication (both written and oral) skills and be able to communicate information effectively with the respective manufacturing facilities and other modalities.
o Proficient in Microsoft Office Tools.

 

Contact:

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