QA Manager

Company Overview
Nanosphere, Inc. (NASDAQ: NSPH) is a nanotechnology-based molecular diagnostics company, offering proprietary breakthrough technologies that provide a unique and powerful solution to greatly simplify molecular diagnostic testing.

Based in Northbrook, IL, Nanosphere employs approximately 110 people. Nanosphere's diagnostic platform has several FDA cleared tests and the company continues with its ambitious growth plans of rapidly bringing new tests and device platforms with enhanced capabilities to the marketplace.

Position Overview
Nanosphere is committed to recruiting an outstanding Quality Assurance Manager during a critical period of the Company's growth and evolution.  The QA Manager will report to a Senior Staff Member of the Company.

A key success factor for this position is the ability to work in a fast paced, cross functional group environment, with a willingness to be hands-on across a wide area of responsibilities.

This ideal candidate is someone with diverse experience and great capacity and desire for taking on new responsibilities and challenges as the company grows.

This position is responsible for developing, implementing and maintaining the Company's Quality Assurance Systems for developing and manufacturing in-vitro diagnostic (IVD) products in the areas of nucleic acid and protein testing. 

Key Responsibilities:

  • Responsible for the development and maintenance of Nanosphere Quality Assurance (QA) Systems. Nanosphere's QA Systems include: Document Controls; Purchasing Controls; Identification and Traceability; Production and Process Control; CAPAs; Labeling and Packaging; Material and Product Handling, Storage and Distribution; Equipment Installations; Manufacturing Records; Maintenance and Service.
  • Working with senior management, ensure the Company's QA system is fully compliant with Quality System Regulations (QSRs) that meet FDA and ISO expectations.
  • Write, review, implement and improve as necessary the standard operating procedures for the QA Systems.
  • Interface with Analytical Development, Manufacturing, Development, Facilities, and Quality Control to effectively implement procedures throughout the company that comply with the applicable FDA QSRs and to monitor on-going progress in procedure and process improvement.
  • Review and approve batch records, change requests, non-conformance and OOS investigations, and prepare Certificate of Compliance for disposition of manufactured product.
  • Responsible for optimizing incoming material receiving, intermediate releases, and final product acceptance and release. 
  • Participate as QA representative on various teams and committees.
  • Audit material suppliers and other vendors such as contract manufacturers and contract analytical laboratories used for QC testing.
  • Lead regular reviews of QA Systems with Nanosphere senior management. 
  • Provide QSR Training to Nanosphere personnel.

Experience and Requirements:

  • Experience with development of Quality Systems required for Medical Devices and/or diagnostics.
  • Ability to easily interpret QSR requirements (21CFR820) and must have demonstrated past successes in implementing the applicable QSRs into QA Systems for organizations that have successfully both designed and manufactured IVD and/or medical devices.
  • Familiarity with global regulatory requirements that pertain to product development and IVD manufacturing (e.g. CE IVD mark).
  • Excellent communication skills and ability to work in a changing environment on complex projects.  Outstanding teamwork and project management skills; ability to interact with external and internal customers on fast-paced projects.
  • Minimum 7 yrs experience working in a QA role in a company that has designed and manufactured an IVD or medical device using QSRs. 
  • Degree in Chemistry, Engineering, Life Sciences, or related field.  Advanced degree is not required.