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Quality Assurance Associate
2 weeks ago
We are seeking a highly skilled Quality Assurance Associate to join our team. The ideal candidate will be responsible for ensuring the quality of sample collection kits, conducting thorough inspections, and maintaining compliant documentation.
About the Role:
- Ensure the quality of sample collection kits by following relevant procedures and conducting incoming inspections of raw materials.
- Prior to product release, review batch paperwork and maintain compliant documentation and records according to site procedures for record control.
- Promptly notify management of any product quality issues, document on-hold notices and quality alerts efficiently, and participate in continuous improvement projects and initiatives at the site.
- Support applicable processes within the Quality Management System (such as Change Controls, Documentation Management, CAPAs/NCRs, Audit Readiness, and Supplier Quality Management).
- Assist management in compiling and presenting daily and weekly Quality metrics.
Requirements:
- A Bachelor's degree, preferably in Science, Quality, Engineering, or a related field, with 1-2 years of experience in the quality assurance department of the medical device or pharmaceutical industry.
- Demonstrates keen attention to detail and capable of managing multiple conflicting priorities with minimal supervision and timely escalation of identified issues to management.
- Strong communication skills, both written and verbal, along with exceptional organizational abilities.
- Proficient technical comprehension, capable of understanding and executing steps outlined in relevant procedures.
- Exceptional troubleshooting, analytical, problem-solving, and root-cause analysis skills.
- Ability to emphasize the importance of ensuring product quality and compliance with regulations.
- Possesses a basic understanding of ISO 13485:2016, FDA 21 CFR Part 820, and other applicable regulations.
Benefits:
- Health insurance and an Employee Assistance Programme.
- Annual Compensation Reviews.
- Flexible Annual Leave after 90 days.
- Free monthly health tests.
- A referral bonus programme to reward employees for helping us hire the best talent.
- Internal Opportunities and Careers Clinics to help you progress your career within the company.
- Bike to work scheme - and secure bike storage onsite.
- Maternity, Paternity, Parental and Wedding leave.