The Design Quality Engineer II plays a pivotal role in ensuring that new product designs and manufacturing processes adhere to all relevant safety and efficacy standards. This entails collaboration with cross-functional teams to identify and mitigate risks, ensure design control compliance, and implement quality engineering activities throughout the product lifecycle.
Key Responsibilities:
* Represent quality interests on project teams
* Lead risk management activities and own quality engineering tasks for NPD projects
* Review design control compliance requirements and develop UFMEA & DFMEA documents
* Perform statistical analysis and initiate corrective actions as needed
* Support biocompatibility testing and participate in internal and supplier audits
This role demands strong problem-solving skills, attention to detail, and excellent interpersonal skills. The successful candidate will have a third-level qualification in engineering, science, or a technical field, along with at least five years of experience in the medical device or pharmaceutical industries.