Quality Assurance Specialist
1 day ago
We are seeking a highly skilled Quality Assurance Specialist to join our team at ATR International. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our products and services.
Key Responsibilities:- Drive preparation of KPI dashboards and maintain a pulse on formal RA management review and internal metrics.
- Manage strategic programs for RA audit preparedness, including anticipatory identification of risks, mitigation of risks identified during the audit process, and preventive actions for risks.
- Support quality system integration for acquisitions and new product introductions.
- Identify and implement system and/or systemic processes.
- Support tracking and maintenance of regulatory post-approval commitments.
- Drive quality system process improvement initiatives, including but not limited to:
- Establishing audit support for integration products.
- Improving and maintaining the quality system procedures (e.g., change management).
- Liaising with cross-functional partners and international affiliates to meet audit compliance needs and driving to implementation/resolution.
- Participating in audit backrooms, and
- Participating in RA projects.
- Role has a potential for investigating nonconformances (CAPAs) and implementing mitigations.
- Exposure to Medical Device US and CE regulations, Quality Systems, a Quality role, or a Compliance role is a plus.
- Independent
- Troubleshooting
- Critical thinker
- Ability to drive a problem through resolution and implement mitigations.
- Ability to handle multiple streams simultaneously.
- MEC/ACP Medical
- Voluntary Dental, Vision, Life, Supplemental Income
-401k (must meet requirements)
-Sick leave as required by state/county
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Quality Assurance Specialist
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