As an integral member of the quality team, the Design Quality Assurance Engineer will provide Quality representation and guidance to R&D in supporting projects for new and existing products in accordance with applicable regulatory requirements. This person partners with R&D, Regulatory and Operations in the development, verification, validation and approval of products.
Foster a 'strong right first time' compliance culture.
Duties and Responsibilities:
- Serve as a quality representative to R&D for all design controls and product development activities.
- Ensure new products are developed per state-of-the-art standards.
- Support design verification and validation, and review V&V test plans and reports to ensure the design outputs meet both system and customer requirements.
- Participate in design and phase gate reviews at all phases of product lifecycle process.
- Partner with internal customers to perform risk management activities including hazard identification, hazard analysis, DFMEA and risk mitigation consistent with ISO 14971.
- Provide guidance to the software team on the application of IEC 62304 to all software.
- Work closely with the NPI team to transfer design into manufacturing.
- Collaborate with cross-functional teams including R&D, Manufacturing, Operations, Service to develop Device Master Records.
- Audit DHFs to ensure compliance with Design Control Procedure.
- Initiate, review and approve Document Change Orders and Engineering Change Orders.
- Act as a technical resource to troubleshoot problems originating from customer complaints.
- Participate in internal and external audits (FDA, Notified Body, etc.)
- Develop standard operating procedures for processes in design controls as required.
- Other duties as assigned.
- Bachelor's degree in Science or Engineering or related discipline.
- Minimum 3-5 years' experience working in a highly regulated medical device environment.
- Detail-oriented with the ability to lead multiple projects and activities assigned.
- Excellent organizational skills, planning, communication and follow up skills.
- Proficient in Microsoft suite, SPC tools.
- Ability to work in a fast-paced, team-oriented environment with strict deadlines.
- Strong knowledge of design controls in medical device.
- Working knowledge of applicable medical device regulations such as 21 CFR 820, ISO 13485:2016, ISO 14971:2019, EU MDR and MDSAP.
- Experience with IEC 60601-1, IEC 62304 and IEC 62366 requirements.
- Significant attention to detail and highly organized
- Demonstrated oral, presentation and technical writing skills
- Strong analytical skills