medtechrec

Quality Engineer

medtechrec  •  Federal Republic of Germany (Onsite)  •  4 months ago
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Job Description

About the Role

We are a fast-growing, highly innovative medical technology company with a strong focus on dental implant solutions. Our multidisciplinary and motivated team works on the development, manufacturing, and global distribution of advanced ceramic-based implant products, as well as the creation of new treatment concepts in biological dentistry.

With an established international presence across multiple markets, we continue to expand our portfolio and global reach. To support this growth, we are seeking a Senior Quality Engineer (m/f/d) to join our team on a full-time basis

Key Responsibilities

  • Ownership of activities related to Quality and Regulatory Compliance, with a strong focus on Quality

  • Responsibility for validation and verification activities, including computer system validation (CSV)

  • Execution and maintenance of risk analysis and risk management activities

  • Test planning and coordination

  • Supplier development and quality oversight

  • Quality support during product development

  • Handling, investigation, and implementation of CAPAs and nonconformities

  • Conducting internal audits and supplier audits, as well as preparation and support for external audits

  • Creation and delivery of training sessions related to quality processes and compliance

  • Maintenance and continuous improvement of the Quality Management System in accordance with ISO 13485, MDSAP, and MDR

  • Support for change management, document control, CAPA, audit, and training processes

  • Support in maintaining and developing regulatory documentation to ensure successful market launch and lifecycle management of products and services

  • Contribution to development-related and technical documentation

  • Promotion of quality awareness in day-to-day business operations

Your Profile

  • Completed degree with several years of relevant professional experience, or extensive professional experience in a comparable role

  • High level of reliability, precision, and quality awareness

  • Structured, independent, and goal-oriented working style

  • Strong communication skills

  • Ability to work effectively both within a team and independently

  • Excellent German skills (spoken and written)

  • Excellent English skills (spoken and written)

  • Proficient in MS Office and standard Quality Management systems/tools

medtechrec

About medtechrec

medtechrec is a consultancy specializing in recruitment services exclusively tailored for the ever-evolving medical device industry.

Boasting 13+ years in healthcare and medical device recruitment, medtechrec has a wealth of experience in Contingent, Search and Contract solutions.

We work closely with our clients to understand their goals and challenges, and develop solutions that address their specific needs.

Our dedicated departments focus on:

Commercial

The average Medical Device company is made up of 40% commercial employees.

We source Sales Reps all the way to CCO's.

QA / RA

We spend as much time finding you quality candidates as they will ensuring that your devices meet regulatory standards and safety requirements.

R&D

Engineers, Project Managers, Scientists and Technical Writers.

With a special focus on finding top graduates.

Clinical Affairs

Clinical Trial Managers, Coordinators, Data Managers, CRAs, Medical Writers, Regulatory Affairs Specialists, and Directors and Managers.

Human Resources

HR Managers, Talent Acquisition Specialists and Customer Service staff, to keep your business ticking.

Finance & Strategy

We have a broad network of Finance Professionals with a background in Medical Devices. Understanding M&A and strategy specifically.

Industry
HR & Recruiting
Company Size
1-10 employees
Headquarters
London, GB
Year Founded
Unknown
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