Senior Quality Engineer
4 weeks ago
An exciting opportunity to join a well-capitalized start up medical device company advancing hand-held, image guided, robotic technology to democratize vascular access in Central Venous Catheterization. This role will provide Quality Engineering support to the Quality/Regulatory, Research & Development and Manufacturing/Operations Functions. This individual will collaborate with other incredibly talented engineers, innovators and industry leaders with highly successful experience in healthcare technology.
ESSENTIAL JOB FUNCTIONS:
·QMS: Support the Quality team in the creation and full implementation of the company’s Quality Management System.
·R&D Design Control Support: Provide Quality Engineering support to the R&D team during ongoing design and development activities (system, hardware, software, electronics) as defined by the company’s design control process.
·Document Control (DCOs): Support the Quality team in the management of the company’s Document Control process related to approval, revision, and ongoing maintenance of controlled documents.
·eQMS: Support the Quality team in identifying, selecting, and implementing an appropriate eQMS platform
·Manufacturing: Provide Quality Engineering support during the transition of the manufacturing process related to the production of the CERTA Access System from the company’s contract manufacturer to Obvius Robotics (e.g., tool control, supplier management, inspections, reworks, nonconformances).
·Project Team Member: Serve as a Quality Engineering representative (including as an independent reviewer) on project teams during the development of new/revised products following the company’s design control process.
·Audits: Support the Quality team during any internal audit as well as any interactions with external organizations including FDA and international regulatory bodies.
·Findings Resolution: Support the Quality and Regulatory team during the resolution of any question or issues from a regulatory body (e.g., nonconformances, 483s).
EDUCATION: Minimum Bachelor’s Degree in an engineering discipline from a four-year college or university
QUALIFICATIONS:
·Minimum 5 year work experience in Quality Engineering in the medical device industry
·Experience should include work within applicable medical device regulations e.g., US – 21 CFR Part 820, International – ISO 13485, EU-MDR
·Experience with basic statistical analysis (e.g., sample size determination during testing)
·Excellent written and verbal communication skills in English
·Ability to apply sound engineering principles as foundation of support to teams within the organization
·Strong computer skills with Microsoft Office, Google suite of applications
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