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Manager, Quality Engineering

Job Summary:

The Manager, Quality Engineering, reporting to Sr. Quality Management, will provide quality leadership and guidance responsible for consistent implementation, improvement and compliance to the NanoString Quality System and global regulatory requirements including, but not limited to: FDA (§21 CFR 820, ISO13485, Canadian Medical Device Regulatory (CMDR), and In Vitro Diagnostic Directive (98/79/EC). This role provides technical, quantitative, and coordination support to ensure products and processes are designed, deployed, and operate according to controlled specifications and requirements.

Essential Duties:

  • Supports collaborative quality input and guidance to NanoString teams to ensure applicable processes and products comply with NanoString policy and procedures.
  • Leads and implements policies and procedures supporting a QSR-compliant Quality System. Emphasis will be placed on critical quality elements (Product Development (Inputs/Outputs), Design Controls, Design Transfer, Design Specifications, Risk Management, Manufacturing, and Quality Control processes and procedures.
  • Guides development and review of Design Transfer activities to include verification/validation of reagent specifications, documentation of manufacturing procedures, verification/validation of inspection requirements for receiving materials and QC tests for in-process and final product materials, definition of product kit component labeling specifications, and successful completion of process validation.
  • Ensures Design Transfer procedures to Contract Manufacturers (CM) follows compliant policy and procedures.
  • Leads a quality team in the gap analysis of controlled Design History File and Device Master File for all products.
  • Issue, review, and maintain quality records for all deviations resulting in non-conformances and NCMR.
  • Review customer complaints collaboratively with Technical Support and Instrument Services sustainability teams; ensure SCAR or CAPAs are issued and investigated, as needed.
  • Develop, implement, review, and improve Quality System procedures as needed.
  • Analyze company data, including customer complaints and non-conformance material reports (NCMRs), for patterns or trends; identify potential problems before they occur; seek out ways to ensure continuous improvement across the organization and all functional areas; identify root cause(s) of problems or concerns and coordinate appropriate response(s)

Requirements:

  • BS in Life Science or Engineering discipline, BME or Ph.D. preferred
  • At least 5 years of experience in the medical device or biotechnology industry
  • At least 1 year of managerial experience
  • Working knowledge of FDA Quality System Regulations (QSR), ISO 13485 and ISO 14971
  • Proven ability to technically prepare and review process validation, failure investigations, non-conforming materials, CAPA and risk assessment protocols and reports
  • Working knowledge of statistical techniques
  • Proven experience in in vitro diagnostic field required
  • Proven ability to technically prepare and review process validation
  • Working knowledge of nucleic acid assay development
  • Ability to Support CAPA and Complaint investigations
  • Ability to train others in quality processes and procedures
  • ASQ certified or CQE preferred
  • Certified Auditor preferred

Other:

  • See benefits at NanoString
  • NanoString is an EOE
  • NanoString participates in E-Verify. E-Verify is a web-based system that allows an employer to determine an employee's eligibility to work in the US using information reported on an employee's Form I-9. The E-Verify system confirms eligibility with both the Social Security Administration (SSA) and Department of Homeland Security (DHS). For more information, please go to the USCIS E-Verify website.

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