Design Assurance Engineer II
Purpose of the Design Assurance Engineer II role:
Fulfil the quality assurance responsibilities of new product development and post market (commercial product) support.
About Your New Job as Design Assurance Engineer II:
* Interfaces with R&D, Regulatory Affairs, Clinical, Medical Safety, Complaints Management Centres and Post Market Quality Assurance team environment providing technical and quality systems input.
* Familiarity with requirements and procedures that govern medical device Design Control
* Represent the function for area of responsibility in both Internal and regulated Authority Audits
* Understanding of Design Assurance requirements to ensure new product/technology transfers comply to all internal and regulatory requirements.
* Identifies and resolves complex exceptions to work assignments.
* Seeks to support improvements in product and process quality.
* Builds Quality into all aspects of work by maintaining compliance to all quality requirements.
* Provides both quality and technical input to ongoing product development and post market commercial product activities.
* Experienced in risk management, design and process change, standards compliance (to regulatory requirements).
* Practical knowledge of 13485 and FDA part 820.
* Excellent analytical and problem solving abilities. Analyses, draws conclusions and makes appropriate decisions from risk management activities and test data.
What Skills You need as Design Assurance Engineer II:
* HETAC Level credits) in a STEM discipline with a minimum of 3-4 years' experience in a similar role.
* Good technical capabilities, communication skills, teamwork abilities and initiative.
* Proven ability to work well as part of a team & on own with minimum supervision
What's Next:
Apply now by clicking the "Apply Now" button or contact me, Karolina, at
If the job isn't quite right but you are looking for something similar, please get in touch.