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2 days ago
We are seeking a highly skilled and experienced quality assurance professional to join our innovative medical device company.
This individual will play a critical role in supporting commercial manufacturing of connected health solutions for chronic wound care.
- Oversee product quality, regulatory compliance, and readiness for inspections across internal operations and contract manufacturing.
- Lead investigations and implement corrective actions to prevent non-conformances.
- Support equipment validations and documentation reviews.
- Monitor supplier quality and contribute to audit preparedness.
- Collaborate with regulatory affairs teams on submissions and inspection readiness.
Key qualifications include:
- Degree in Engineering, Quality, or a related discipline.
- 3-7 years of experience in QA or manufacturing quality within a regulated industry.
- Strong knowledge of ISO 13485, FDA QSR, and process validation.
- Experience supporting regulatory audits.
We offer a dynamic work environment that fosters growth and development. If you are a motivated and detail-oriented individual with a passion for quality and innovation, we encourage you to apply for this opportunity.
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