Information Security Officer (ISO)

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.

Due to our constant growth, we are looking for a Senior Medical Device Consultant to support our projects in the DACH Area.

You will be responsible for:

• Participate in multiple projects in the medical devices sector, ensuring timely delivery and adherence to project budget and customer needs.
• Support QA and RA activities at Medical Device Companies.
• Ensure compliance with regulatory requirements and quality standards (e.g., FDA, ISO 13485, MDR and IVDR).
• Establish, implement, review and update QMS procedures.
• Coordinate and collaborate with cross-functional teams, including Management, Operations, and Sales Team.
• Perform projects for Medical Device Process Validation.
• Perform compliance assessment in the Medical Device area.
• Support Compliance projects for Medical Device Companies.
• Create an effective, sustainable compliance strategy.
• Comply with European Device Directives and obtain CE Marking for your medical device.
• Conduct internal and supplier audits (ISO 13485, FDA's QSR).
• Implement an effective corrective and preventive action (CAPA) process.

Assist with:

• Design control and documentation.
• Design verification and validation.
• Software verification and validation.
• Clinical Evaluation.
• Post Market Surveillance, Post Market Clinical Follow Up.

About you:

• At least 6 years of experience in the Medical Device industry.
• English and German language proficiency.
• Willingness to travel in the DACH Area.
• Degree in a technical discipline.
• Medical Device requirements (ISO 13485, 14971, MDR / IVDR, 21 CFR part 820, …).
• Process Validation in accordance with GHTF Guidance.
• Medical Device Processes (Molding & Extrusion, Automatic Assy, Fluids Processes, …).
• Process Mapping and Risk Analysis techniques (FMEA, HACCP, …).
• Design of Experiment, Gage R&R.
• V&V requirements.
• Good at English protocols writing.

Location: DACH

Next Steps:

Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview. If there's a positive match, a technical interview with the Hiring Manager will be arranged. In the case of positive feedback from the Hiring Manager interview, the recruiter will contact you for the next steps or to discuss our proposal. Alternatively, if the feedback is negative, we will contact you to halt the recruitment process.

Working at PQE Group:

As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills, and interact with colleagues from all corners of the world.

If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you. Apply now and take the first step towards an amazing future with us.