Risk Management Specialist
3 semanas atrás
Hello If you have a deep passion for ensuring product safety and reliability, we have an exciting opportunity for you.
Job Summary:We are seeking a highly skilled Quality Consultant to join our team. As a Quality Consultant, you will be responsible for ensuring that product safety and reliability are planned within the entire product lifecycle. You will apply suitable techniques and methods to ensure concerted and effective safety risk and failure mitigation.
Key Responsibilities:- Coordinate cross-functional teams in executing product safety risk management activities.
- Create and maintain product-specific safety risk files.
- Develop product-specific risk policies in alignment with the risk management framework.
- Assess quality information and customer feedback for impact on product risk and customer safety.
- Develop an annual review schedule of relevant process documentation.
- Collect, analyze, and report data from other quality processes and internal and external regulatory databases.
- Collect, analyze, and report data for gap analyses as needed for current and new projects.
- Maintain departmental SOPs and related attachments as assigned.
- Manage and process workflows, approvals, records, and other tasks as required for responsible products.
- Bachelor's degree in physical science, engineering, or a related field, preferred.
- 2+ years of experience in a highly regulated industry, preferably within the Medical Device, pharmaceutical, or life sciences industry.
- Thorough working knowledge of relevant international ISO/IEC Standards (13485, 14971, 62304, 62366, 82304).
- Knowledge/Experience in regulations (MDSAP, MDD/IVDD, MDR/IVDR, 21 CFR - Part 820), and associated guidances preferred.
- Direct risk management experience, i.E. PRA or FMEA, or experience/knowledge of ISO 14971.
- Demonstrated ability to communicate, collaborate, and influence effectively with a variety of internal/external stakeholders.
- Project management experience with proven leadership, mentoring, and coaching abilities.
- Strong interpersonal, analytical, and problem-solving skills.
- Salary package based on your profile.
- Permanent Contract.
- Learning and Development opportunities.
We are an equal opportunities employer and welcome applications from all qualified candidates. Please note that we do not discriminate based on age, disability, gender, marital status, nationality, race, religion, or sexual orientation.
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