Job Title: Senior Manufacturing QA
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About the Role:
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* We are seeking a highly experienced and skilled Senior Manufacturing QA to support quality assurance across manufacturing processes and external suppliers.
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Key Responsibilities:
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1. Oversee manufacturing quality for electronic and system-level production, ensuring compliance with relevant industry standards.
2. Lead root cause investigations and manage CAPAs (Corrective Action Preventive Actions) to identify and mitigate potential issues.
3. Support process validations (IQ/OQ/PQ) and documentation reviews to ensure accuracy and completeness.
4. Manage supplier quality performance and participate in audits to maintain high-quality standards.
5. Ensure compliance with ISO 13485 and FDA 21 CFR Part 820 regulations and related standards.
6. Drive continuous improvement initiatives to enhance quality and efficiency.
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Requirements:
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* Bachelor's degree in Engineering, Quality, or a related field.
* 3-7 years of experience in QA or manufacturing in a regulated industry, preferably medical devices.
* Strong knowledge of CAPA, non-conformances, and process validation.
* Excellent communication skills and attention to detail.
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Preferred Qualifications:
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* Experience with contract manufacturers.
* Certifications (CQE, Six Sigma, Auditor).
* Familiarity with QMS/ERP systems (e.g., Greenlight Guru, MasterControl).
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About Us:
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This is a fantastic opportunity to join a dynamic team and contribute to the development of high-quality medical devices.
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