Quality Assurance

hace 1 mes

DonostiaSan Sebastián Guipúzcoa provincia, España Merlin Digital Partner A tiempo completo

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, 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 13485 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 13485 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 13485, 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._

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