The Mechanical Designer-QPL is responsible for the implementation of comprehensive process validation plans, ensuring smooth transitions of new products to production
Job Summary
The Mechanical Designer-QPL is responsible for the implementation of comprehensive process validation plans, ensuring smooth transitions of new products to production.
The Quality Engineer is accountable for oversight of system and hardware quality and risk management throughout the product life cycle.
We believe that we are better together than apart.
Matching Summary
The Mechanical Designer-QPL is responsible for the implementation of comprehensive process validation plans, ensuring smooth transitions of new products to production.
Skills & Requirements
Must-have
Process validation plans
Design control process
Regulatory and quality standards compliance
Risk management expertise
Quality System requirements adherence
Hardware design quality assurance
Nice-to-have
Independent technical assessment
Post-market analytics and statistics
Cross-functional and global decision direction
Presentation skills
Dispute solving skills
Key Requirements
Minimum 5 years in quality assurance
Strong design control and new product development experience
Professional knowledge in ISO 13485, FDA 820, ISO14971, FDA/MDR/MDSAP
Fluent in English both in writing and speaking
Experience in the medical industry or highly regulated industry