Quality Assurance Specialist
7 days ago
Quality Assurance Specialist
We are seeking a talented Quality Assurance Specialist to drive our manufacturing quality initiatives forward.
Key Responsibilities:- Initiate and Approve Change Controls: Develop, implement and maintain change control processes to ensure compliance with industry regulations.
- Maintain Compliance for Product Manufacturing: Verify that product manufacturing, packaging and labeling meet regulatory requirements.
- Develop Sampling Methods: Design and implement sampling strategies to ensure accurate representation of products.
- Write and Review CAPAs, NCs/NCMRs and SCARs: Create, review and finalize corrective action plans, nonconformance reports and supplier correction action requests.
- Perform Internal and Supplier Audits: Conduct thorough audits to verify compliance with industry standards.
- Support Regulatory Body Audits: Collaborate with external auditors to ensure seamless audit processes.
- Degree-Level Qualification: Hold a degree in Quality, Science or Engineering.
- Regulated Environment Experience: Possess minimum 3 years' experience working in regulated environments (medical device, FDA or ISO 13485 registered).
- Computer Skills: Proficient in MS Excel, PowerPoint and Word.
- Statistical Tools: Familiarity with Pareto charts and trend charts.
- Root Cause Analysis Tools: Familiarity with FMEAs and root cause analysis techniques.
- Problem-Solving Techniques: Effective problem-solving and communication skills.
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