NanoComposix is a privately-held R&D, and manufacturing company that develops innovative nanomaterials for research and commercial markets supporting medical devices, and pharmaceuticals.  We manufacture hundreds of different variants of metal and metal-oxide core/shell nanocomposites for a wide range of applications including biosensors, medical devices, clinical diagnostics, and optical effects.  Our mission is to help our clients bring nano-enabled products to market.  We’re passionate about what we do and are looking for smart, energetic, and self-motivated individuals who take pride in their work to join our fun and innovative team in this exciting industry.  

Benefits include medical and dental insurance, paid vacation and personal days, retirement plan with company-match, and an annual bonus program with opportunity for stock ownership in this employee-owned business.

Position Summary

The Director of Quality Assurance will oversee the activities of the Quality Assurance department and staff, developing, implementing, and maintaining the Quality Management System for nanoComposix's nanoparticle based medical device, and pharmaceutical products; and support development of processes in compliance to 21 CFR, EU MDR, and ISO 13485.

Principal Duties and Responsibilities

§  Develops, implements, and manages processes to ensure that products meet required specifications for quality, function, and reliability prior to delivery.

§  Identifies and sets appropriate quality standards and parameters for products.

§  Communicates quality standards and parameters to QA team, product development team, and other appropriate staff.

§  Coordinates product testing processes.

§  Identifies and analyzes issues, bugs, defects, and other problems, particularly when problems recur in multiple products; recommends and facilitates solutions to these issues.

§  Reviews client, customer, and user feedback.

§  Maintains compliance with federal, state, local, and organizational laws, regulations, guidelines, and policies.

Supervisory Responsibilities

§  Hires and trains Quality Assurance staff.

§  Oversees the daily workflow and schedules of the department.

§  Conducts performance evaluations that are timely and constructive. 

§  Handles discipline and termination of employees in accordance with company policy. 

Education

§  Bachelor’s degree.

Experience

§  At least Five years ISO 13485 /FDA compliant Quality System management experience in Lateral Flow Point-of-Care / Medical Device / Pharmaceuticals industry.  

Knowledge/Skill

§  Excellent understanding of Lateral Flow Assay Quality Assurance requirements, including Design Control.

§  Excellent verbal and written communication skills.

§  Excellent interpersonal and customer service skills.

§  Excellent organizational skills and attention to detail.

§  Excellent time management skills with a proven ability to meet deadlines.

§  Strong analytical and problem-solving skills.

§  Strong supervisory and leadership skills.

§  Proficient with Microsoft Office Suite or related software.

Human Resources Requirements

Physical Demands

§  Must be able to lift up to 15 pounds at times.

Work Environment

§  Primary office work with lab exposure.

§  Prolonged periods of sitting at a desk and working on a computer.

§  COVID – minimum 50% on-site.

APPLICATION PROCESS

Qualified candidates should submit a resume and cover letter. The cover letter should include information on how your previous experience relates to the job requirements and your availability. Specific examples are of interest. You will not be considered without a cover letter.

Candidates must be eligible to work in the United States. 

All your information will be kept confidential according to EEO guidelines.