Responsible for establishing and maintaining a Quality System that complies with FDA and ISO requirements. Provides oversight and direction for the preparation and submission of FDA 510(k)s. Champions continuous improvement efforts and defect reduction initiatives to establish an effective Quality System. Developing quality system improvement plans is also a key function of this position.
Ensures the activities of all departments of Neolight remain in compliance with FDA, ISO, Quality System, and regulatory requirements
Educates and trains employees as to their impact in the quality management system
Supports concurrent engineering efforts by participating in design development projects representing quality assurance
Designs, implements and documents procedures for process control, process improvement, testing and inspection
Establishes collection and analysis systems of statistical data to predict trends that will affect improvement of product quality
Performs Validations (IQ, OQ, PQ, MSA) by creating SOP’s and protocols
Support post-market investigations through quality systems such as NC/CAPA, and PFA
Responsible for coordinating and overseeing Regulatory Affairs, Quality Assurance and Clinical Affairs
Compiles statistical data and writes narrative reports summarizing quality findings.
Analyzes, designs, and/or improves difficult manufacturing procedures and engineering systems for post-market medical devices.
Serves as management representative to regulatory agencies, during audits, to demonstrate compliance.
Schedules and conducts and/or coordinates internal and external audits; prepares and issues summarized reports; maintains quality surveillance of suppliers. Interface with supplier quality representatives concerning problems with quality and assure that effective corrective action is implemented.
Oversee reviews and approve validation, design/product transfer, calibration and preventative maintenance programs to ensure consistent implementation of the programs.
All other duties, as assigned.
Bachelor’s degree in mechanical engineering, electrical engineering, manufacturing engineering or business administration, or equivalent number of years of experience;
Minimum five (5) years of experience in Quality and Regulatory Affairs
Experience working with FDA and audit preparedness;
Experience working in the medical device industry a must;
Experience with 21CFR820, Quality Systems Regulation and ISO 13485 a must.
Experience performing validations (IQ, OQ, PQ, MSA, CQ)
Effective communication, planning and organizational skills.
Demonstrated ability to manage projects and multiple priorities.
Demonstrated knowledge and ability to use common software tools for spreadsheet, word processing, and presentation tasks.
Planning: Ability to think ahead and plan over a 2-5-year time span.
Compensation On par with market salary, stock compensation and a performance based incentive
Duration 3-6 months (but likely to be extended FTE)
Location Phoenix, Arizona
Employer Neolight is a neonatal medical device firm located at Scottsdale, Arizona. We aim to create empathy-driven solutions to newborn care and become a thought-leader in neonatal space by 2020. We started off with a phototherapy device to eradicate Kernicterus by treating Jaundice affected babies.
1. Unlimited leave policy
2. Health, Vision & Dental Insurance
3. Visa sponsorship if required
4. Stock options
Note Neolight participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees
Additional Application InstructionsPlease send us an email to email@example.com that includes the following: A resume detailing your professional experience A cover letter (with specifics about your interest in this specific role, specifically with Neolight), A list of no more than 3 professional references (including their name, relationship to you, email address, and phone number)
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