1 day old
2018-04-232018-05-23

Quality Compliance Analyst II

Terumo
Elkton, MD
  • Job Code
    379942
JobId: 379942
JobTitle: Quality Compliance Analyst II
Department: Corporate_Compliance
Location: Elkton
Description: Job Summary: This position is responsible to assist the Compliance management staff with implementation of best practices to optimize quality, efficiency and productivity in systems throughout TMC and other Terumo facilities. Specifically, the position is responsible for assisting with review of new and revised standards and regulations against current practices, supporting the effectiveness & compliance of TMCÙs Quality System. As part of this responsibility, the position will also track and report progress of specific Quality System indicators for management review. Position will participate as an active Compliance\/independent representative on project teams. As part of the extended project team, this associate will be responsible for assuring that design history files are compliant with regulations and TMC business needs, by verifying files at strategic milestones, including at the end of each design control phase. Position is also responsible for assisting with third party\/regulatory audits. Job Details: 1. Manage monitoring of new and revised standards and regulations a. Chair External Standards Committee. b. Report out to Management on changes impacting compliance to external standards and regulations. 2. Review new and revised standards and regulations to verify compliance of TMC systems 3. May participate in Quality System or product enhancement projects 4. Develop and maintain expertise in quality management standards, software and tools applicable to Terumo Medical Corporation a. Good documentation practices, ISO 13485, GDP, validation and verification\/qualification. b. Develop and maintain expertise in applicable quality regulations, including, but not limited to: i. U.S. Food and Drug Administration (FDA) current Good Manufacturing Practice (cGMP) for Medical Devices (21 CFR 820). ii. Health Canada cGMP, iii. European MDD 93\/42\/3EC 5. Provide ongoing reinforcement of compliance and quality culture. 6. Review and draft proposals to implement changes to the Quality System procedures\/forms as needed to maintain compliance, improve effectiveness and efficiency. 7. Act as independent reviewer on design control projects to ensure compliance with internal procedures and external standards and regulations. 8. Assist and\/or conduct internal audits to assess compliance with applicable regulations and standards (e.g. - Quality System Regulation (QSR), ISO 13485, ISO 14971, ISO 11607, ISO 11135\/ EN550, ISO 11137\/ EN552 and the amended Medical Device Directive). 9. Assist with third party\/regulatory audits (Customer, Notified Body, FDA) 10. Monitor and remain current with internal company procedures\/policies, international QS standards and regulations 11. Assist the Compliance Manager with tasks such as FDA correspondence and maintaining communication with all domestic and overseas Terumo facilities. These duties must be performed in such a manner as to assure that strict confidentiality is maintained. 12. Performs other job related duties as assigned.

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Quality Compliance Analyst II

Terumo
Elkton, MD

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Quality Compliance Analyst II

Terumo
Elkton, MD

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