Indivi
Biotech
QualityProcessAnalyst
Neural analysis suggests this role is
optimal for Mid candidates.
“Quality Process Analyst at Indivi. Skills: Quality Management, Regulatory Compliance, Product Lifecycle. Collaborate with cross-functional teams to identify and mitigate. Build and maintain collaboration between teams”
What You'll Achieve.
Ensure QMS compliance; Ensure product quality; Ensure product safety
Industry & Context.
Problem-solving skills
What They're Looking For.
Must Have
Previous experience in software development, Minimum of 2 years of previous experience in the SaMD or Digital Health industry or similar, Previous experience in participating in the development of new products and ensuring regulatory requirements are incorporated into the design and development process, Basic understanding of ISO 13485, Basic understanding of privacy regulations, Ability to deliver high-quality documentation, Ability to prioritize tasks, Ability to meet deadlines, Ability to adapt to changing regulatory requirements, Ability to adapt to industry trends, English proficiency is essential (minimum B2)
Nice to Have
University degree in Computer Science, University degree in Engineering, University degree in a related technical field, Other degrees or relevant qualifications, Certification in a relevant area is a plus, Knowledge of Spanish is advantageous
What You'll Do.
Collaborate with cross-functional teams to identify and mitigate
Build and maintain collaboration between teams
Support the establishment of product technical dossiers
Review and approve documents and records
Delegate complaint management
Lead product change management process
Conduct internal audits
Develop and maintain QMS related processes
Develop and maintain QMS related documentation
Develop and deliver training to employees
Participate in the development or maintenance of products
Ensure compliance requirements are incorporated into the design
Support product risk assessments
Support risk mitigation strategies
Support validation strategies
Support the supplier evaluation
Support the supplier qualification
Analyze trends in complaints
Analyze trends in nonconformances
Identify systemic issues
How You'll Work.
Team & Collaboration
Cross-functional teams; Product team; Development teams; Quality team
Communication Scope
Written communication; Verbal communication
Process & Methodology
Change management
Full Job Description
Your mission Indivi is a TechBio company enabling precision and personalised medicine to become a reality in neuroscience research and development. We are going through significant growth and looking for new team members who want to contribute to making our vision — making measurable what is not so — a reality. Your profile As a Quality Process Analyst, you will play a key role in ensuring that our software products in the Digital Health / SaMD space are developed, maintained, and released in full compliance with applicable regulatory and quality requirements. Responsibilities Quality Management / Compliance / Product Lifecycle Oversight Collaborate with cross-functional teams to identify and mitigate product and regulatory risks throughout the product lifecycle. Build and maintain collaboration between the product team, the development teams and quality team. Support the establishment of product technical dossiers. Review and approve documents and records to ensure QMS compliance, product quality and safety. Delegation of complaint manager. Lead product change management process to ensure changes are assessed according to their impact, correct documents are included and approver and change team are identified. Conduct internal audits to ensure compliance with applicable procedures and standards. Develop and maintain QMS related processes and documentation. Develop and deliver training to employees, if applicable. Participate in the development or maintenance of products and ensure compliance requirements are incorporated into the design and development process. Support product risk assessments and risk mitigation strategies as well as validation strategies. Support the supplier evaluation and qualification. Support the development and maintenance of product technical dossiers. Analyze trends in complaints and nonconformances to identify systemic issues and drive improvement. Necessary Competence (Education / Qualification) A University degree in Computer Science, E
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