Senior Quality Assurance Specialist
1 week ago
Job Title: Senior Quality Assurance Specialist
About the Role:The Senior Quality Assurance Specialist plays a vital part in ensuring product quality, regulatory compliance, and continuous improvement within a regulated environment.
Key Responsibilities:- Initiate and complete technical and cost-saving activities for process improvements including risk documentation, test methods, process/software validation, and procedural updates.
- Initiate, review, and approve change controls.
- Perform statistical analysis and interpret data using appropriate statistical tools and methods.
- Develop and implement effective sampling strategies.
- Write and review CAPAs, non-conformance reports (NC/NCMRs), and supplier corrective action requests (SCARs).
- Ensure ongoing compliance in Product Manufacturing, Packaging, and Labelling.
- Conduct internal and supplier audits to verify compliance.
- Support and participate in external audits by regulatory bodies (e.g., ISO, FDA).
- Collect, compile, and analyse Quality Metrics and other performance data.
- Maintain compliance with training requirements and associated documentation.
- Follow Environmental, Health and Safety (EHS) and CGMP policies and procedures.
- A degree-level qualification in Quality, Science, or Engineering is required.
- Minimum of 3 years' experience in a regulated environment, preferably within the medical device sector or an FDA/ISO 13485 certified environment.
- Strong attention to detail.
- Strong computer proficiency, especially in MS Excel, Power Point, and Word.
- Familiarity with statistical tools (e.g., Pareto charts, trend analysis).
- Experience with risk management tools such as FMEAs and root cause analysis.
- Strong problem-solving skills.
- Clear and effective communication skills - both verbal and written.
- Ability to work in a fast-paced, team-oriented environment.
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