
Senior Quality Assurance Specialist
2 weeks ago
Job Overview:
Evaluate quality issues with suppliers, apply problem-solving methodologies to identify and resolve issues, and ensure quality standards are met.
Key Responsibilities:- Maintain knowledge and understanding of ISO 13485:2016, MDSAP, MDR, and ISO Standards.
- Review and approve supplier corrective action plans and verification of effectiveness documentation.
- Support the development and maintenance of supplier qualification/re-qualification activities for suppliers.
- Support ongoing Quality Improvement projects and initiatives as required.
Requirements:
- Bachelor's degree in Engineering or Science or equivalent experience.
- Awareness of worldwide applicable regulations for Quality Systems (EU MDR, ISO 13485, 21 CFR 820).
- Experience working within quality processes such as CAPA, Complaint Management, Risk Management.
- Conduct audits to international standards such as ISO 9001:2015 and ISO 13485:2016.
- Results-oriented, organized, and able to manage time effectively.
- Effective communication skills in an international environment with external partners and key stakeholders.
Why Choose This Role:
This role offers a collaborative work environment, flexible employment options, and a chance to make a meaningful impact in the life sciences industry.
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