Senior Quality Assurance Engineer, Medical Devices
4 days ago
We are seeking an experienced Quality Assurance Engineer to join our team at SG11 CIBA VISION Asian Mfg & Log Pte Ltd Company.
About the RoleThis is a challenging opportunity for a qualified professional to lead and support quality assurance activities for medical devices. As a Senior Quality Assurance Engineer, you will be responsible for ensuring that our products meet the highest standards of quality, safety, and regulatory compliance.
Job DescriptionKey Responsibilities:
- Lead and support quality assurance activities, including design transfer, manufacturing operation, and product release;
- Conduct investigations for non-conformances, customer complaints, and other quality issues;
- Review and approve validation protocols and reports to ensure compliance with established procedures and sound validation methodology;
- Act as quality approver for non-conformances, site change controls, and other quality-related documents;
- Provide e-compliance oversight to site CSV activities and oversee site NC CAPA process;
- Trend, analyze, and monitor key performance indicators to identify improvement opportunities and implement changes to improve performance and efficiency;
- Support internal and external audits and be responsible for audit finding closure;
- Collaborate with cross-functional teams to resolve operational quality issues;
- Meet quality objectives set by management and comply with Alcon QMS and Safety requirements.
To succeed in this role, you should have:
- A Bachelor's Degree in Science, Life Science, Engineering, or a related field;
- At least 2-3 years of experience in Quality Assurance or Quality Control in a pharmaceutical and medical device industry;
- Excellent communication and problem-solving skills;
- The ability to work independently and collaboratively as part of a team;
- Good understanding of regulatory requirements and industry standards.
We offer a competitive salary package, including a base salary of $80,000 - $100,000 per annum, depending on experience, plus benefits and opportunities for professional growth and development.
$90,000 - $110,000 per annum, based on location and experience.
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