We are looking for a Quality Engineer with prior Medical Device experience to join a team of 10 engineers working toward delivering a brand new medical device over the next 2 years You will be leading the Quality organization for pilot manufacturing quality initiatives and limited post market activity, as well as playing a role in design assurance. .
- Review, create and edit technical files and design control documents for medical devices with integrated hardware and software in accordance with QMS system and applicable regulations
- Work with contract manufacturers to ensure quality standards are met.
- Prepare and review design verification test protocols, procedures and reports
- Drive risk management file activities and updates inclusive of hazard analysis and DFMEAs and the inform risk management approach for engineering
- Assist engineering in the compilation of design history files in accordance with ISO 13485, ISO14971 Risk Management and IEC 60601 or other applicable USFDA and EUMDD regulations
- Support potential ISO 13485 certification, CAPAs and audits (internal and external)
- BS in Engineering, Bioengineering with at least 5 years of experience working with medical device design FDA, ISO or other regulated environment and/or equivalent combination of education and experience.
- Experience in product & process development
- Proficient with medical device product and process risk management