Quality Engineer (m/w/d)

Overview

Are you ready to apply your technical expertise for the benefit of people? We are looking for a Quality Engineer (m/w/d) based in Nonnweiler to join pfm medical gmbh, an internationally active midsize family business in Germany. The company focuses on delivering premium healthcare products and services with a patient-centric approach, ensuring better therapy outcomes and optimal working conditions for users in hospitals, clinics, care facilities, and laboratories.

Key Responsibilities

• Documenting, analyzing, and addressing customer, supplier, and internal complaints related to medical devices through 8D reports.
• Participating in decision-making processes concerning mandatory reporting to domestic and international authorities.
• Developing, applying, and executing standardized testing procedures.
• Performing inspections and tests within the quality control laboratory as part of complaint handling.
• Examining and assessing retention and complaint samples.
• Conducting compliance evaluations and managing deviations and CAPA actions according to EN ISO 13485 and CFR Title 21 Part 820 standards.
• Coordinating and monitoring product and process changes triggered by CAPA.
• Contributing to product and process verification and validation activities including design control, process validation, and change management.
• Creating, maintaining, and implementing risk policy documents aligning with EN ISO 13485 and particularly ISO 14971.

Candidate Profile

• Completed technical or scientific university degree.
• Preferably prior experience in medical technology.
• Project management experience and ability to oversee project execution.
• Desirable experience with conducting validations following international guidelines.
• Fluent English communication skills, both spoken and written.
• Strong knowledge of manufacturing and assembly processes, project management methodologies, and product development.
• Preferred familiarity with international medical device regulations and norms such as MDR, EN ISO 13485, CFR Title 21 Part 820, and ISO 14971.
• Capability to formally evaluate quality-critical processes and routines.
• Independent, organized, and responsible approach to work.
• Excellent team spirit and strong communication abilities.
• High result orientation paired with a strong quality awareness.
• Effective time and self-management skills.

Additional Information

If you feel this role may not exactly match your background but would like to leverage your professional experience in a new field, we also welcome career changers. We provide the necessary knowledge and training on-site in Nonnweiler.

Our culture values respectful interaction, emphasizing openness, kindness, and patience, especially when working with diverse individuals.

Benefits Offered

• Flexibility and trust through trust-based working hours, opportunities for remote work, and modern technology to allow you control over your daily work schedule.
• Generous vacation entitlement of 30 days with the possibility of exchanging additional leave days for salary components after two years.
• Attractive perks including employer-financed company pension after three years, monthly tax-free benefits (e.g., Jobrad bicycle program), and assets-building schemes.
• Support through all life stages with internal assistance during special circumstances, including special leave options, as well as access to an external Employee Assistance Program (EAP).
• Targeted training and professional development programs to enhance your personal and career growth.

Application Process and Confidentiality

To apply, please proceed by submitting your application for the Quality Engineer position in Nonnweiler directly online. If you have questions beforehand, contact details are available. The hiring process includes a short telephone interview followed by an in-person meeting to discuss details.

For candidates currently employed elsewhere, we guarantee strict confidentiality throughout your application process. Telephone interviews and personal meetings can also be scheduled outside regular working hours.

We look forward to receiving your application!