Quality Process Analyst

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, Engineering, or a related technical field is preferred. Other degrees or relevant qualifications might be considered.

• 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 and privacy regulations.

• Ability to deliver high-quality documentation, paying attention to detail.

• Excellent written and verbal communication skills.

• Strong problem-solving skills

• Able to prioritize tasks and meet deadlines.

• Ability to adapt to changing regulatory requirements and industry trends.

Needed skills or mandatory training:

• Certification in a relevant area is a plus.

• English proficiency is essential (minimum B2). Knowledge of Spanish is advantageous.