Device & Combination Product Development Quality Engineer
Our client is a public Swiss Specialty Pharma company listed on the SIX Swiss Stock Exchange focusing on the discovery and development of macrocycle drugs addressing high unmet medical needs. These macrocycles represent a new drug class complementary to the classical small molecules and large biopharmaceuticals. They are currently looking for a Device & Combination Product Development Quality Engineer.
- Accountable and responsible for Quality engineering product & process development from concept to market launch.
- Provide sound Quality expertise to develop new product and timely address quality resolution for devices, combination product and packaging, and implement end to end effective control strategy and operational control plan.
- Execute all Quality Engineering activities & tasks defined for the product including GMP & ISO documentation management internally and at suppliers, support to Regulatory filings and maintaining inspection readiness.
- Oversight and manage Quality Assurance and Quality Control at device suppliers and tests service providers.
- Responsible for the development, implementation and validation of all test methods required to effectively functionally characterize products.
- Ensure qualification of Combination Product assembly process internally for clinical phases.
- Effectively collaborate with all project functions and communicate quality requirement for industrialization of the product.
- Maintain an overview of applicable quality standards and their evolution within the related business.
- Ensure compliance with all local, state, federal, and company quality policies, procedures and practices, safety regulations, policies, and procedures.
Qualifications and Experience:
- Undergraduate degree in related quality engineering field, advanced degree desired.
- Minimum 7 years of experience in quality engineering or technical combination product development & industrialization with 5 years in medical or pharmaceutical industry
- Successful track record of delivering products to market.
- Demonstrated medical device, combination product and packaging development quality engineering skills.
- Broad and deep understanding of disciplined quality product development processes, regulatory, and quality / risk management systems (ISO 13485, MDR, 21CFR820, ISO14971…)
- Demonstrated supplier quality management skills.
- Advanced Problem-solving skills and statistical knowledge
- Advanced skills in method validation
- Experience in leading a team
- Fluency in English
- Relevant working/residency permit or Swiss/EU-Citizenship required