Design Quality Engineer Role
We are seeking a highly skilled Design Quality Engineer to play a crucial role in ensuring the quality of our products. The successful candidate will have a strong understanding of regulatory standards, including ISO 13485 and ISO 14971.
About the Job
* This is a senior-level position responsible for leading risk management activities and owning quality engineering activities for new product development (NPD) projects.
* You will represent quality interests and concerns on project teams and lead multiple projects from inception to launch and maintenance.
The ideal candidate will have experience with UFMEA & DFMEA, statistical analysis, and process optimization. They should also be able to develop and implement corrective actions as required.
Key Responsibilities:
* Represent quality interests and concerns on project teams.
* Lead risk management activities and own quality engineering activities for NPD projects.
* Balance multiple projects and tasks, from product inception through product launch and maintenance.
* Review design control compliance requirements for NPD projects and all design elements.
* Develop UFMEA & DFMEA, coordinate guidance from other design sub-team members, and support PFMEA development.
* Perform DOE's and statistical analysis to support product and process optimization or resolve causes of process variation.
* Initiate corrective actions as required.
* Support assessment of biocompatibility testing required as per ISO10993 and company procedures.
* Participate in internal audit and supplier audit programs.
* Risk management - U/DFMEA; Risk Analysis, Risk Management File and Gauge R&R and Test Method Validation.
This role requires someone who can manage multiple projects independently while collaborating effectively in team settings and meeting deadlines consistently.