QuinTalent Inc
This range is provided by QuinTalent Inc. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $40.00/hr - $45.00/hr
Direct message the job poster from QuinTalent Inc
Work Environment Hybrid - 8am - 5 pm Monday to Friday, with 3 days on-site every week.
Contract Duration 6 months, with a pay rate of $40/hour to $45/hour.
Role Overview The candidate needs to have an understanding of risk, primarily organizing information, identifying gaps, converting files, etc.
The Quality Associate will assist in updating and consolidating legacy product risk management files related to IVDR.
Key Responsibilities:
Facilitating risk management assessments, updating risk plans and reports, and consolidating product system hazard analysis files according to company procedures and standards.
Coordinating and facilitating meetings with cross-functional stakeholders to gather complete and accurate risk data, identify new risks, and update risk profiles.
Escalating significant events to management for further action.
Supporting the migration of product risk management files into the eQMS system, ensuring proper documentation and linkage to legacy DHF binders.
Assessing legacy risk documentation against current IVDR guidelines and identifying gaps.
Assisting with other IVDR-related documentation updates and gap assessments, including migration into eQMS.
Adapting to a dynamic environment with shifting priorities, maintaining patience and support for cross-functional teams.
Working independently with a sense of ownership and accountability.
Qualifications:
Bachelor’s degree or equivalent in a scientific or technical field.
3-6 years of experience or equivalent education and experience.
Basic knowledge of quality assurance principles and theories.
Understanding of Medical Device/GMP/ISO regulations (ISO 14971, ISO 13485, MDSAP, FDA CFR Part 820).
Fundamental understanding of risk management regulations and applications.
Excellent critical thinking, problem-solving, coordination, teamwork, communication, and technical skills.
Experience with SAP, EtQ, and/or Veeva.
Proficiency in Microsoft Office and Visio.
Additional Details:
Seniority level: Mid-Senior level
Employment type: Contract
Job function: Manufacturing and Healthcare Provider
Industry: Medical Equipment Manufacturing
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Base pay range $40.00/hr - $45.00/hr
Direct message the job poster from QuinTalent Inc
Work Environment Hybrid - 8am - 5 pm Monday to Friday, with 3 days on-site every week.
Contract Duration 6 months, with a pay rate of $40/hour to $45/hour.
Role Overview The candidate needs to have an understanding of risk, primarily organizing information, identifying gaps, converting files, etc.
The Quality Associate will assist in updating and consolidating legacy product risk management files related to IVDR.
Key Responsibilities:
Facilitating risk management assessments, updating risk plans and reports, and consolidating product system hazard analysis files according to company procedures and standards.
Coordinating and facilitating meetings with cross-functional stakeholders to gather complete and accurate risk data, identify new risks, and update risk profiles.
Escalating significant events to management for further action.
Supporting the migration of product risk management files into the eQMS system, ensuring proper documentation and linkage to legacy DHF binders.
Assessing legacy risk documentation against current IVDR guidelines and identifying gaps.
Assisting with other IVDR-related documentation updates and gap assessments, including migration into eQMS.
Adapting to a dynamic environment with shifting priorities, maintaining patience and support for cross-functional teams.
Working independently with a sense of ownership and accountability.
Qualifications:
Bachelor’s degree or equivalent in a scientific or technical field.
3-6 years of experience or equivalent education and experience.
Basic knowledge of quality assurance principles and theories.
Understanding of Medical Device/GMP/ISO regulations (ISO 14971, ISO 13485, MDSAP, FDA CFR Part 820).
Fundamental understanding of risk management regulations and applications.
Excellent critical thinking, problem-solving, coordination, teamwork, communication, and technical skills.
Experience with SAP, EtQ, and/or Veeva.
Proficiency in Microsoft Office and Visio.
Additional Details:
Seniority level: Mid-Senior level
Employment type: Contract
Job function: Manufacturing and Healthcare Provider
Industry: Medical Equipment Manufacturing
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