QUALITY ASSURANCE (MEDICAL DEVICE)

We are Merlin Digital Partner ! A leading IT and Digital headhunting company who stands out from the crowd, boasting over a decade of experience.
We've successfully collaborated and played a pivotal role in the growth of industry heavyweights such as Wallapop, Glovo, Banc Sabadell, and Factorial, among others.
Our emphasis lies in people-centric approaches and optimizing the selection processes.
Our mission is to revolutionize companies by seamlessly integrating top-tier talent.
What sets us apart is our in-depth understanding of each partner (being their best influencer!), addressing not only their needs but also capturing their essence.
We are currently looking for a  Quality Assurance specialist or Responsible  Our Partner, is a start-up that is developing and will commercialize medical devices able to select the best human spermatozoa, increasing the effectiveness of assisted reproductive treatments.
The Mission.
The Quality Assurance will lead the development, implementation, and maintenance of quality assurance standards and procedures in accordance with ISO and the Medical Device Regulation (MDR).
This key role involves overseeing compliance activities, ensuring the manufacturing and distribution processes of medical devices adhere to quality standards, and managing quality documentation and records.
The Role.
Oversee the implementation and maintenance of the quality management system (QMS) in line with ISO and MDR requirements.
Monitor and report on the performance of the QMS, leading the analysis and driving improvements based on performance indicators.
Lead internal and external quality assurance audits and regulatory agency inspections.
Oversee the preparation of regulatory submissions and compliance activities related to the QMS.
Ensure all SOPs, controlled documents, and QMS documentation are current and in compliance with regulatory standards.
Direct training programs for quality and regulatory compliance.
Manage nonconformance issues, corrective and preventive actions (CAPA), and customer complaints processes.
Oversee the conduct of internal audits to ensure continuous improvement and compliance within all areas of the company.
Coordinate and lead on-site audits conducted by external providers or regulatory agencies.
Key Activities.
Lead the regular strategic review of quality management processes.
Direct risk management activitie s related to product quality and compliance.
Oversee the validation and qualification of processes and systems to ensure consistent product quality.
Facilitate management review meetings and contribute to executive-level decision-making regarding quality assurance.
Lead product quality and safety surveillance activities.
What we expect from you.
Bachelor’s or Master’s degree in a scientific, engineering, or related field.
Extensive experience in quality assurance, with a strong preference for experience within the medical device industry.
In-depth knowledge of ISO , MDR, and other relevant regulations and standards.
Proven track record in leading quality audits and inspections.
Languages.
Fluent command of English (additional languages are beneficial).
IT.
Advanced competency in using quality-related IT systems and databases.
Exceptional leadership, teamwork, and collaboration skills.
Strong communication and interpersonal skills, with the ability to influence and engage direct and indirect reports.
Advanced analytical and strategic problem-solving abilities.
Rigorous attention to detail and a commitment to achieving high-quality outcomes.
Capacity to handle multiple complex tasks and projects in a leadership role.
Expert proficiency in the use of quality management software and tools.
Benefits.
Opportunities for professional growth and career advancement.
A dynamic, innovative work environment where creativity and new ideas are encouraged.
Flexible working environment.
Are you ready to be part of the challenge? Contact us! *Please note that this is a Hybrid position (Full time.
40 hours/week) > Bilbao / San Sebastian, Spain (On-site 3 days a week in San Sebastian) + Occasional travel may be required for meetings with regulatory bodies or industry events.