Quality Engineer - Job Description
MacroMedics is a dynamic international company with development, production and worldwide sales of patient positioning products for radiotherapy. With a passionate team, we are working enthusiastically on new solutions and products for radiotherapy as innovation is one of our core values. MacroMedics develops high quality medical devices in accordance with market requirements and international regulations.
MacroMedics is looking for a capable Quality Engineer to play a key role in the Quality Assurance and Regulatory Affairs (QARA) Department.
- Creating and maintaining elements relating to the Quality Management System and Product Technical Files.
- Leading risk management meetings and maintaining the risk file.
- Leading verification and validation activities.
- Maintaining production, labelling and packaging procedures.
- Coordinating the maintenance of clinical evaluation reports.
- Liaising with Design, Production and Logistics departments.
- Performing a limited amount of internal audits.
- Performing other tasks as required by the QARA Department.
Core competencies/ Personal attributes
- Energetic, motivated and data-driven personality.
- Ability to think strategically and also to pay close attention to detail.
- Strong analytical and problem solving skills.
- Willingness to work hands-on with procedures and records.
- Strong organizational skills.
- Strong ability to prioritize tasks.
Key skills, knowledge and experience
The ideal candidate would:
- Have a Bachelor’s degree in a related discipline (e.g. engineering, law).
- Have previous experience in a similar role in a regulated industry (preferably medical device or pharmaceutical).
- Have working knowledge of one or more of the following: ISO 13485, 21 CFR 820, or the EU Medical Device Directive 93/42/EEC.
- Have demonstrated successful project management experience.
- Be willing to take on a diverse role with enthusiasm and professionality.
- Be able to produce accurate and compliant documentation.
- Be fully proficient in English, particularly written English.
Additional preferred skills and experience
- Additional Knowledge of Dutch is preferred.
- Experience with Inventor is a bonus.
- Familiarity with EU Medical Device Regulation 2017/745 is a bonus.
Terms of employment
- Initial 1 year contract, with opportunity for extension.