Quality Assurance Manager
19 hours ago
Quality Assurance Leader
The role of Quality Assurance Leader is pivotal in ensuring the highest standards of quality control in a medical device manufacturing facility. Key responsibilities include overseeing the daily activities of quality control inspectors and technicians, ensuring adherence to company standards and preventing delays or product unavailability.
Additionally, this position involves developing and implementing quality control procedures that align with regulatory requirements, such as ISO 13485 and DRAP regulations. It also entails monitoring the timely disposition of raw materials, packaging materials, and finished products based on priorities set with Manufacturing, Marketing, and Materials Management.
This Quality Assurance Leader will also be responsible for reviewing the daily QC Lab planning schedule, monitoring adherence to quality standards, regulations, and best practices. Regular audits of QC processes will be performed to ensure continuous improvement.
Key areas of focus include:
- Product Stability Testing & Evaluation: Ensuring the implementation of product stability testing & evaluation as per SOP to verify shelf-life compliance and identify quality issues related to product stability.
- Quality Data Analysis: Gathering and analyzing quality data, generating reports, and suggesting actions for quality improvement.
- Quality Issue Investigation: Investigating quality issues or non-conformities and collaborating with other departments to resolve them.
- Vendor Qualification: Ensuring all vendors are qualified and comply with vendor standards, collaborating with suppliers to maintain material quality and conducting evaluations and audits as necessary.
- Audit Readiness: Assisting in preparing for and participating in external audits and inspections, providing required documentation and evidence of compliance.
The ideal candidate will possess a pharmacy, biomedical engineering, or biotechnology degree recognized by HEC, along with a minimum of 5-6 years of experience in quality control and testing, preferably within a medical device manufacturing environment, with at least 4 years in a supervisory position. Certification in quality control or quality management systems (e.g., CQE, CQA) is preferred. In-depth knowledge of ISO 13485, DRAP regulations, and other relevant standards for medical device manufacturing is essential.
Exceptional leadership and team management skills, strong analytical and problem-solving abilities, meticulous attention to detail, and effective communication skills are required. This position offers a unique opportunity to work in a dynamic and challenging environment where you can apply your skills and experience to drive improvements and ensure the success of the Quality Control Department.
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