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
Austin Vita is acting as an Employment Agency in relation to this vacancy.
Austin Vita is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.
Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.