Medical Device Development Quality Assurance Expert
Vor 3 Tagen
Gerresheimer: A Leading Global Partner in the Healthcare and Beauty Industries
We are seeking a highly skilled Medical Device Development Quality Assurance Expert to join our team.
Job Summary:
The successful candidate will be responsible for ensuring compliance with quality requirements for drug delivery systems and medical devices in development projects.
About the Role:
- Lead the development of complex medical devices, collaborating with cross-functional teams to ensure quality and regulatory compliance.
- Define and implement quality management systems, ensuring the conformity of products and product documentation over the entire product life cycle.
- Collaborate in risk analyses and create documents for design verification/design validation.
- Release test plans/test setups/design of experiment and review/approve changes to product design and manufacturing processes.
- Act as the primary contact for customers and suppliers regarding product quality, including measures such as NC/CAPA/SCAR/etc.
- Participate in equipment qualification/process validation and evaluation of external production partners.
- Represent the company in audits by customers or authorities.
Requirements:
- Bachelor's degree in a technical or scientific field or equivalent.
- At least 3 years of experience in the field of medical technology products, pharmaceuticals, and/or in-vitro diagnostics.
- Practical experience in risk management methods for medical devices.
- Familiarity with quality and problem-solving techniques.
- Knowledge of regulatory requirements for medical devices (MDR/EN ISO 14971/21 CFR 820/EN 13485).
- Ability to work in a structured and result-oriented manner.
- Proactive approach, prioritization, and decision-making skills.
- Solution-oriented and communicative personality.
- Excellent communication skills across all hierarchical levels, internally and with customers.
- Williness to travel up to 10%.
- Very good oral and written language skills in German (B2) and English (C1).
Salary Information:
We offer a competitive salary, estimated at €80,000 - €110,000 per year, depending on qualifications and experience.
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