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Responsible for performing a wide variety of activities to ensure compliance with the QMS and applicable regulatory requirements by facilitating CAPAs, reviewing/analyzing data, supporting product sustaining issues, developing procedures, and reviewing changes to documentation. Additional responsibilities include supporting customer quality by analyzing complaints and communicating issues with cross functional team for timely resolution.
- Execute procedures and processes to support the Quality Management System
- Participate in the preparation of audits by potential partners, customers and regulatory agencies
- Develop/review QA system SOPs to ensure compliance, as required
- Review customer complaints
- Review device history record, special instructions, Planned/Unplanned Deviation, rework instructions, QC test data.
- Provide quality metrics when appropriate.
- Oversee site calibration process.
- Perform Change Order process, Non-Conforming Material process, investigation and closure.
- Assures compliance to in-house and/or external specifications and standards, such as cGMPs and ISO regulations (documentation review, internal audits)
- Provide administrative and project support in the area of quality.
- Assist Quality manager in establishing, implementing, maintaining, and improving the quality management system
- Create and maintain company quality documentation
- Participates in process and operation improvement opportunities
- Responds to internal and external inquiries
- Complies with company quality management systems, policies and procedures
- Provides mentorship, if applicable.
- Additional duties/responsibilities according to business need.
- Associate Degree or equivalent related experience
- 1-3 years of QA experience in a manufacturing setting
- Interpersonal skills, Results oriented
Bachelor’s in Life Science Discipline
3-5 years of QA experience in a manufacturing setting
Experience in Batch Record Review, Calibration and Complaint Management
Experience with CQA, CQE
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