Director of Quality Assurance
il y a 4 semaines
Company Overview:
As a key division of the SASMAR group, a renowned provider of medical devices and food supplements worldwide, we are committed to upholding the highest standards of quality and regulatory compliance. Our products adhere to global regulatory requirements, including ISO 13485, ISO 9001, FDA guidelines, and other relevant regulations across various markets.
**Responsibilities**:
- Provide strategic leadership in quality assurance, overseeing global regulatory and quality compliance efforts for medical devices and food supplements within the SASMAR group.
- Develop and implement comprehensive quality assurance strategies in alignment with ISO 13485, ISO 9001, FDA, and other international regulations.
- Lead global quality audits and ensure compliance with regulatory standards, acting as the lead auditor for ISO 13485 and MDD (Medical Device Directive) across all regions.
- Collaborate with regional quality teams to establish harmonized quality control processes and ensure consistent adherence to global regulatory requirements.
- Drive continuous improvement initiatives to enhance quality processes, product safety, and regulatory compliance throughout the SASMAR group.
- Monitor and address quality issues, deviations, and corrective/preventive actions on a global scale.
- Conduct risk assessments and implement risk management strategies to mitigate quality-related risks in different markets.
- Serve as the primary contact for regulatory agencies, certification bodies, and global audits to support and manage quality compliance across all business units.
**Requirements**:
- Bachelor's degree in a relevant field; advanced degree preferred.
- Extensive experience in quality assurance leadership roles within the medical device and food supplement industries, with a strong background in global regulatory compliance.
- Certified lead auditor for ISO 13485 and proficient in MDD requirements.
- In-depth knowledge of ISO 9001, FDA regulations, and global quality standards.
- Strategic thinker with proven experience in global quality oversight and harmonization efforts.
- Excellent communication skills and the ability to collaborate with diverse teams and stakeholders in different regions.
- Detail-oriented, organized, and skilled in managing complex global quality projects.
- Willingness to travel internationally as required to support global quality initiatives.
**Benefits**
- Competitive compensation and benefits package
- Opportunities for international exposure and career advancement within a global group
- Collaborative and innovative work environment with a focus on quality and compliance excellence
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