NanoComposix is a privately-held R&D and manufacturing company that develops innovative nanomaterials for research and commercial markets.  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.

nanoComposix Inc., has an immediate need for a Quality Assurance Manager (Part-Time) experienced in the medical device and/or pharmaceutical industries.  This is a unique opportunity to support nanoComposix bring a wide variety of medical devices, topical therapeutics, and nanomedicines through clinical trials to commercialization.  

Position Summary

The Quality Assurance Manager (Part-Time) will be responsible for Quality department management and supporting various aspects of the Quality Management System, including: document control, non-conforming materials program management, calibration program management, batch record/device history records reviews, training program management, quality record management, internal audit / external audit management, developing and measuring Key Quality Initiatives. The position is part-time with approximately 20 hours a week on-site.

Key Duties and Responsibilities:

• Manage the Quality Department.
• Manage the Document Control function and maintain all Quality Management System records.
• Support Manufacturing in generating and revising Bill of Materials, Raw Material Specifications, Labels, Finished Good Specifications, and Batch Records.
• Support R&D and Manufacturing Product Development in the Design Control process through Clinical Trials, and Commercialization. Transfer of methods to Manufacturing Batch Records.
• Manage the Calibration & Preventive Maintenance Program activities and maintain related records.
• Manage the Employee Training Program.
• Manage non-conforming material (NCR) & CAPA activities.
• Manage the Approved Supplier Program.
• Perform Batch Record/Device History Records reviews for product release.
• Coordinate and Manage Internal Audit activities, External Audit activities, Key Quality Initiatives.

Requirements:

• Minimum – Associates Degree
• Working knowledge of GDP; FDA 21 CFR, Part 820, Quality System Regulations; and ISO 13485.
• Working knowledge of: FDA 21 CFR, Part 210 & 211; ISO 9001 a plus.
• Exceptional organizational skills
• Excellent written and verbal communication skills
• Capable of supporting cross-functional project goals with a Quality focus
• Ability to work effectively in a positive, fast-paced, start-up, team environment

Desired Skills:

• Medical Device Experience – 10 years minimum in an application requiring chemical, biological, or nanomaterial reagent manufacturing.
• SOP and Batch Record Experience – 10 years minimum drafting and releasing standard operating procedures and batch production records
• Management Experience – 10 years minimum
• Quality Assurance/Quality System Experience – 10 years minimum
• Scientific background in biology or chemistry

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.

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