Our client is a leading medical device company and is currently seeking an accomplished Senior Quality Specialist to join the team. Here is an overview of the role:
1) Stay aware of company's quality policy and quality objectives and provide support to achieve them
2) Perform all document control activities - processing DCO's, maintaining Doc Control and DCO Master logs, and document files, follow-up on DCO Action items
3) Maintain training records and monitor training compliance
4) Order and maintain external standards
5) Maintain the Non-Conforming Material and Corrective and Preventive Action System, including NCMR (disposition, review, approval), CAPA (initiation, review, verification, effectiveness check), Complaint Handling (support handling, investigation, and reporting) to ensure timeliness of actions and tracking metrics to support management review
6) Handle equipment calibration and maintenance per the applicable SOPs
7) Oversee DHR review and approval for release of finished products
8) Maintain design history files and clinical release records
9) Ensure product being shipped for sterilization of documented and processed per applicable SOPs, ensure records are maintained, and prepare metrics as appropriate (i.e. bioburden trending)
10) Oversee the service request function
11) Be responsible for incoming and final acceptance activities, ensure proper documentation is maintained and prepare metrics as appropriate
12) Assist the preparation of management review presentations and maintenance of records
13) Monitor controlled storage areas monthly for expired product/accuracy
14) Maintain supplier quality program (i.e. supplier files, approved supplier list, supplier audits, supplier performance metrics, etc.)
15) Assist in performance of internal audits
16) Recommend improvements in quality system to ensure that the quality system is efficient and effective controls are in place to minimize risk
17) Follow and enforce compliance with company's quality system
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