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Job Title Design Quality Engineer
Job Description If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request. You may contact 888-367-7223, option 5, for assistance.In this role, you have the opportunity toThe Quality Engineer will be assigned to R&D and Post Market Surveillance teams supporting the design life cycle and transfer of the products into manufacturing, ensuring compliance with the Quality System Regulations, especially 21 CFR Part 803, 806, 820 and ISO 13485. In this position you will provide independent oversight for system and hardware quality during the design input process, design V&V activities, product realization and contribute to complaint closure, Failure analysis, Risk Management and Quality Reviews.You are responsible for- Ensures appropriate quality and design plans are created that include all stages of the life cycle of the product
- Performs and completes assigned complaints investigations, including but not limited to Product Failure Analysis and complaint documentation review (DHR, complaints history, products instructions, risk management, etc.) and prepare investigation reports.
- Work with cross functional groups such as New Product Development and Sustaining Engineering to ensure Quality problems have been identified and contained.
- Prepare information for Quality Management Reviews and Operational Reviews such as: trend charts, Pareto Analysis, etc., as required on complaint data.
- Evaluation of complaint information received from clinical environments, such as device failure mode, manufacturing documentation review, labeling and instructions for use review.
- Follow up on Implementation of corrective and preventive actions.
- Assist the Research and Development department to verify that; modifications to the manufacturing processes and/or product design do not affect product suitability for its intended use.
- Ensure compliance to EU MDR requirements, particularly Annex I, the General Safety and Performance Requirements, (GSPR).
- Performs other duties as needed to ensure compliance with relevant FDA QSRs, EU MDR and other ISO regulations.
- US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
- B.S. degree in an engineering discipline, Electrical Engineer degree or a related technical field or equivalent is highly preferred.
- ASQ (CQE, CRE, CQA) Certifications a plus.
- 3+ years of experience as a Quality/Reliability Engineer, Design Engineer working within the framework of a Quality System.
- Experience with medical device manufacturing required- with electronic and/or electromechanical products preferred.
- Experience with design review processes, and capable to perform risk analysis in accordance with EN ISO 14971:2012 and develop and document risk mitigation plans desired. Previous experience with SAP MRP or QM module and TW desired
- Working knowledge of EU MDR requirements, particularly Annex I, the General Safety and Performance Requirements, (GSPR).
- Excellent written and verbal communication skills with demonstrated ability to work cross-functionally across different functional groups and demonstrated ability to prioritize and manage multiple tasks and projects effectively and efficiently.
- ID: #21628598
- State: California Carlsbad 92008 Carlsbad USA
- City: Carlsbad
- Salary: USD TBD TBD
- Job type: Permanent
- Showed: 2021-10-24
- Deadline: 2021-12-20
- Category: Architect/engineer/CAD