July 24, 2024

Ambit BST

Évora

Quality Consultant in Risk management (100% remote)

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 :

Ensure that product safety and reliability are planned within the entire product lifecycle during initial product creation and subsequent changes by applying suitable techniques and methods to ensure concerted and effective safety risk and failure mitigation.
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).
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 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.