The Quality Engineer-Design role will be integral to the development and commercialization of next-generation molecular diagnostic devices. They will be part of the Quality Assurance Department, collaborating closely with other departments such as Biology, Engineering, etc. This person will serve as QA department representative on broader product development teams, owning QA deliverables as part of the project plan. This individual will assist & guide Quality team members, and cross-matrix team members, to complete other deliverables as applicable. This role will develop and deploy quality processes, templates, and procedures related to product development, such as risk management, design inputs/outputs, design verification and validation. The position will contribute to the development and improvement of the overall Quality Management System (QMS) as assigned.
- Designated design quality engineering representative on product development teams, providing quality leadership to ensure product specifications, applicable standards, and regulatory requirements are met
- Support the generation/approval of documents related to design verification and validation, test method validation, process validation, supplier qualification, product specifications and drawings, hazard analysis, FMEA, risk management file, etc. as part of the product development process
- Provide quality oversight of testing related to product development processes
- Provide quality leadership on cross-functional teams in root cause analysis investigation and resolution activities
- Executes activities related to risk management, post-market surveillance, and design history file maintenance
- Serve as the design quality engineering representative as part of change control, non-conforming product, CAPAs, complaints, etc.
- Support the development and improvement of the QMS through the creation of processes and authoring of procedures related to quality-driven activities in product development
- Provide technical quality support for regulatory filings
- Support internal and external inspections/audits
- Perform other duties and responsibilities as assigned by management
- Bachelor of Science in Engineering or Science-related field, or equivalent years of education and experience required
- At least 5 years of experience in medical device or biotechnology industries
- Experience with 21 CFR 820, ISO 13485 and ISO 14971, design controls, risk management, design verification and validation, statistical methodologies
- Experience working with medical device product development teams, preferably IVDs (PCR technology/platform a plus)
- Experience with all phases of product development, from early definition to commercialization
- Experience working with suppliers (qualification, change control, etc.)
- Familiar with relevant standards related to product development and definition, such as ISO 62304, ISO 62366, IEC 60601, CLSI standards, etc.
- Experience working with embedded software preferred
- Ability to work collaboratively, explain the Why, and be able to influence others in a fast-paced environment
- Ability to operate independently with minimal supervision
- Ability to lead projects and participate as a quality subject matter expert in team environments
- Have excellent written and verbal communication skills able to train others in quality principles and operations
- Possess a high level of attention to detail and organization
Candidate they seek will bring an educational foundation in Engineering or science related field, and has worked in an OEM Design environment ideally with clinical diagnostics, medical device, or biotechnology industries and brings proficient to expert level skills with owning the quality initiatives while supporting, advising and collaborating with core product development and R&D. This Candidate will own all QA deliverables and will develop, and deploy quality processes, procedures, templates, design controls, design verification and validation. This will be someone who brings strong experience with risk management, can ensure product specifications and regulatory requirements and can support and improve the current QMS.Why is This a Great Opportunity:
We have recently been engaged by a private equity funded company working to commercialize a disposable, hand-held, sample-to-answer, battery-powered PCR testing device. Their exciting platform uses real-time, RT-PCR, and requires no technical expertise to operate, and delivers on-the-spot results in under one hour. Their vision is to enable simple, affordable, rapid, and accurate disease testing for everyone. As they continue to move towards commercialization, they require a Quality Engineer; Design.