As Director of Quality you will be responsible for building iota’s Quality Management System, collaborating with all departments within the company to ensure compliance to process/procedures related to Design Controls, Usability, Risk Management, and Software Quality.
Responsibilities for this position include, but are not limited to, the following:
Establish and implement iota’s Quality Management System (QMS).
Ensure continuous improvement of the QMS along with GMP and GLP compliance.
Ensure products are developed and manufactured in accordance with applicable industry standards, regulatory requirements, customer requirements, and product specifications.
Prepare, oversee, and conduct internal and external audit programs.
Direct CAPA initiatives and measure effectiveness of corrective actions.
Review and approve changes to controlled documents and processes such as SOPs, specifications, etc.
Provide direction to employees and direct reports regarding processes related to Design Controls, Usability, Risk Management, Software Quality.
Ensure Risk Management and Hazard Analyses strategies are established in cooperation with cross-functional engineering teams per project requirements.
Ensure compliant documentation including Design History Files, Device Master Records, and Device History Records.
Position requires 10-20% travel.
Bachelor’s degree in Engineering or related field.
Minimum 8 years of experience in a Quality function in a Medical Device company.
Strong technical capability, verbal and written communications skills and effective interpersonal skills.
Leadership experience in a Quality function.
Experience implementing quality process improvement initiatives.
Ability to multitask, prioritize and meet deadlines.
Experience with document control, document review and auditing.
Understand and working knowledge of standards (ISO 13485, IEC 60601, 21 CFR 820, 21 CFR 11).
Experience with Class III active implantable devices.
ASQ certification desirable
Additional Salary Information: Health/Dental/Vision Plan 100% paid for by iota Biosciences; 401k
About iota Biosciences
iota Biosciences, Inc. is a medical device startup dedicated to bringing novel bioeletronic devices to market. Bioelectronic devices are the start of a an entirely new form of medicine, where miniature devices treat chronic diseases through mechanisms like electrical stimulation or collect disease diagnostics at a specificity or frequency not previously possible.
Iota’s core technology stack enables a custom ultrasound wand to communicate with and power custom implantable devices, eliminating the need for wires or batteries and making it possible to produce tiny medical implants. This product concept is based on the ground-breaking “neural dust” technology initially developed at UC Berkeley. From this academic proof of concept, iota Biosciences is developing a family of miniscule yet effective and manufacturable medical products.