We are supporting an exciting medical device organisation who are looking for an experienced Process Engineer / Manufacturing Engineer who is ready to take the next step into Quality Engineering.

This is not a traditional Quality Assurance role. We are looking for someone with a strong engineering mindset who understands manufacturing processes, enjoys problem-solving, and wants to develop their career within medical device quality.

You will work closely with engineering, development, laboratory teams and external manufacturing partners to ensure products are successfully transferred into manufacturing while maintaining the highest standards of quality and compliance.

Key Responsibilities

Process Engineering & Manufacturing Readiness

- Support the transition of medical device products from development into commercial manufacturing.
- Work closely with engineering and operations teams to understand manufacturing processes and identify opportunities to improve product quality and robustness.
- Support technology transfer activities between internal teams and external suppliers.
- Review and support manufacturing process validation activities including FAT, SAT, IQ/OQ/PQ, MSA and Gauge R&R; studies.
- Ensure manufacturing processes are appropriately controlled, documented and validated.

Supplier & Component Quality Support

- Support the quality oversight of external suppliers and manufacturing partners.
- Work alongside the Project Quality Engineer to manage supplier activities across multiple components and suppliers.
- Support supplier qualification, performance reviews and improvement initiatives.
- Assist with investigations into supplier-related issues and support corrective actions.





Quality Engineering & Problem Solving

- Support investigations into manufacturing issues, non-conformances and process deviations.
- Apply structured problem-solving techniques including root cause analysis, PFMEA and risk-based thinking.
- Support CAPA activities and ensure corrective actions are effectively implemented.
- Work with engineering teams to understand how process or design changes impact product quality.

Quality Systems & Compliance

- Support compliance with medical device regulations including ISO 13485, EU MDR and internal quality procedures.
- Assist with technical documentation, quality records and project documentation.
- Support continuous improvement activities across manufacturing processes and supplier quality.

About You

You are likely to be a:

- Process Engineer
- Manufacturing Engineer
- NPI Engineer
- Validation Engineer
- Biomedical Engineer
- Quality Engineer with strong manufacturing exposure

You will have:

- Experience working within the medical device industry.
- A background in manufacturing, process engineering or product industrialisation.
- Experience supporting process improvements, validation activities or manufacturing transfers.
- Exposure to quality tools such as RCA, CAPA, PFMEA or control plans.
- Strong communication skills with the ability to work with engineering teams, suppliers and international stakeholders.
- A proactive approach with the ability to manage tasks independently and drive actions forward.

Why Join?

This is an excellent opportunity for an engineer who wants to move beyond traditional manufacturing support and build a career within Medical Device Quality Engineering.

📌 Process engineer (España)
🏢 Planet Pharma
📍 España