Vacancy expired!
My global medical device client based in South Orange County is looking to bring on a full-time Senior Design Quality Engineer focused heavily on design and NPD. This role offers a competitive base, bonus and benefits package with PTO and extensive career development opportunities. Responsibilities Include:
- this individual will be the Quality Core Team Member for ensuring products are developed/manufactured utilizing appropriate processes to design the highest level of quality into products as they are developed
- Effectively utilize quality tools and processes such as product and process controls, risk analysis/management tools, validation, design verification, investigations, CAPA data, etc. to assure product quality.
- Assures conformance with regulations of the FDA and other international regulatory agencies and may assist in providing responses to the FDA and other regulatory agencies with respect to medical device compliance.
- Provides compliance guidance concerning development, application, and maintenance of quality standards as related to product development within the quality system.
- Participate in design reviews, test readiness reviews, cross functional teams, risk assessments, design transfers, etc.
- Strong knowledge of medical device standards, including but not limited to:
- ISO 13485, ISO 14971, EU MDR, ISO 8534, ISO 11607
- Bachelor's degree in engineering (Electrical, Mechanical, Bio-medical) or related field from an accredited college or university is required.
- 5+ year's experience in R&D or Quality is required.
- ASQ CQE certification required or the ability to obtain within one year.
Vacancy expired!