View Our Website View All Jobs

Senior Manager, Quality Engineering

Job Summary:

The Senior Manager, Quality Engineer, reporting to the Director of Quality Assurance, 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).

In collaboration with multi-departmental stakeholders from R&D, Product Development, Operations, Supply Chain, Manufacturing, Quality Control, and Quality Assurance, this role develops procedures and workflows to support applicable design control, design transfer, process change, risk management, and supplier-related activities supporting Life Sciences, RUO and Diagnostics products.

Essential Duties:

  • Provide collaborative quality input and guidance to NanoString teams to ensure applicable processes and products comply with NanoString policy and procedures.
  • Develops 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.
  • Develop and release 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.
  • Ensure Design Transfer procedures to Contract Manufacturers (CM) follows compliant policy and procedures.
  • Lead a quality team in the gap analysis of controlled Design History File and Device Master File for all products.
  • Assures all products, processes and systems comply with NanoString product development and change management policies, procedures, and specifications.
  • Review, analyze and report on quality discrepancies related to assembly, process and product function systems and guide development of disposition and corrective actions for recurring discrepancies.
  • Work directly with Manufacturing and Quality Control to ensure that inspections, statistical processes, and control analyses are conducted on a continuing basis, as specified, to enforce requirements and meet specifications.
  • Establish, monitor status to internal and external quality performance metrics and drive continuous improvement for assigned quality elements.
  • Present performance metrics and status of critical issues to management team.
  • Organize and prioritize work with minimal guidance and manage priorities, projects and special requests in a timely and effective manner.
  • Lead cross-functional problem-solving teams to drive process and product improvements; use of QA methodologies to manage and facilitate issue resolution including root cause investigations and the development, implementation, and monitoring of effective corrective and preventive actions.
  • Manage and develop a growing team of quality engineers to operate at their highest potential.
  • Support organizational management goals, and provide mentoring and training of direct reports.
  • Works with NanoString Management, Consultants, and Staff to develop practical solutions to achieve regulatory compliance and support quality process improvements.

Requirements:

  • BS, MS, or PhD in Biological Sciences, Chemistry, Biomedical Engineering, or related discipline, with a minimum of 15, 10, or 5 years of experience, respectively.
  • Industry experience working in a regulated environment adherent to FDA QSR, ISO 13485:2016, and ISO14971 QSR-compliant, cGMP processes and principles.
  • support organizational management goals, and provide mentoring and training of direct reports.
  • Evaluate quality data and perform trend analysis.
  • Proven ability to perform risk assessment and maintain risk management files (RMF, RMP, HA, FMEAs, RMR).
  • Working knowledge of NGS, multi-variant nucleic acid & protein assay development and IVDD, a plus
  • ASQ certified, CQE, Six Sigma Green Belt, a plus

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.

#LI-MS1

Read More

Apply for this position

Required*
Apply with Indeed
Attach resume as .pdf, .doc, .docx, .odt, or .rtf (limit 5MB) or Paste resume

Paste your resume here or Attach resume file

To comply with government Equal Employment Opportunity / Affirmative Action reporting regulations, we are requesting (but NOT requiring) that you enter this personal data. This information will not be used in connection with any employment decisions, and will be used solely as permitted by state and federal law. Your voluntary cooperation would be appreciated. Learn more.
Gender
Race/Ethnicity
Veteran/Disability status