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Quality Consultant in Risk Management
4 semanas atrás
Hello If you are have a deep knowledge, curiosity and passion for the **Product/QMS safety risk management,** we have the perfect position for you
**WHAT WILL BE YOUR MISSION**:
- 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, and incorporate this information into product safety risk management activities.
- Develop an annual review schedule of relevant process documentation.
- Collect, analyze, and report data from other quality processes and internal and external regulatory databases to ascertain impact of data to current safety risk management and execute periodic review.
- 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.
**WHAT WILL MAKE YOU SUCCEED IN THIS POSITION**:
- 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), regulations (MDSAP, MDD/IVDD, MDR/IVDR, 21 CFR - Part 820), and associated guidances preferred.
- Demonstrated ability to communicate, collaborate, and influence effectively with a variety of internal/external stakeholders in demanding/changing situations (medical, scientific, engineering, and production) to build trust, confidence, and collaboration toward shared objectives.
- Project management experience with proven leadership, mentoring, and coaching abilities.
- Strong interpersonal, analytical, and problem-solving skills.
- Preference for experience in area of safety risk management with associated skills and cross-domain knowledge of the interface processes.
- English fluent.
**SCHEDULE**:
- 08/09h -17/18h from Monday to Friday (flexible)
- 100% **Remotely from Portugal.**
**CONDITIONS**:
- Salary package based on your profile.
- Permanent Contract
- Learning and Development
- Our goal is that you are well in every way_
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