Design Quality Engineer Role
We are seeking a skilled Design Quality Engineer to drive quality, lead risk management activities, and ensure compliance with global regulatory standards.
About the Position
This is an excellent opportunity for a qualified individual to be at the heart of new product development, collaborating with cross-functional teams to bring safe, effective, and life-changing products from concept to launch.
Main Responsibilities
1. Lead Risk Management Activities: Manage UFMEA, DFMEA, PFMEA processes, and maintain accurate documentation.
2. Ensure Design Control Compliance: Oversee design control compliance across all NPD projects, ensuring adherence to regulatory standards.
3. Perform Statistical Analysis: Conduct DOE, process optimization, and variation resolution analyses, and initiate corrective actions as needed.
4. Support Biocompatibility Testing: Ensure biocompatibility testing per ISO 10993 standards.
5. Contribute to Internal and Supplier Audits: Participate in internal and supplier audits to ensure quality and compliance.
Required Skills and Qualifications
* Bachelor's degree in Engineering, Science, or a technical field.
* 5+ years' experience in the medical device or pharmaceutical industry.
* Strong knowledge of ISO 13485, ISO 14971, ISO 10993, and relevant CFRs.
* Detail-oriented, adaptable, and a natural problem solver.
* Ability to manage multiple projects while thriving in a collaborative team environment.
Benefits
* Pension plan.
* Comprehensive healthcare package.
* Enhanced benefits package.