Operations Quality Engineer II

Our Mission is to Map the Universe of Biology.

As the pioneer in the field of spatial biology, NanoString enables scientists across the globe to envision molecular interactions in three dimensions with three different systems, the nCounter Analysis System, the GeoMx Digital Spatial Profiler (DSP) and the CosMx Spatial Molecular Imager (SMI) platform. As a result, scientists can see the multiomic expression of genes and proteins in the natural context of tissue structure. The secret sauce to the company's success is our people, who are committed to excellence and dedicated to catalyzing the next biological revolution. Collectively, we live our corporate values of ambition, grit, ingenuity, authenticity, and customers every day.

The Operations Quality Engineer II supports the quality system processes and activities associated with the manufacturing of NanoString products. The scope of this position includes quality engineering, support for design controls, supplier and incoming quality, risk management, and quality oversight over manufacturing processes.

The Operations Quality Engineer II provides technical, quantitative, and coordination support to assure products and processes are designed, deployed, and operated according to requirements. Work scope of this position includes management of key processes relating to quality engineering tasks, ensure robust design controls, supplier quality, risk management, tech transfer to manufacturing operations and driving KPI affecting quality in manufacturing.

This individual ensures consistent implementation, improvement, and compliance to the NanoString Quality System and global regulatory requirements including, but not limited to; the FDA Quality System Regulation (QSR), Canadian Medical Device Regulatory (CMDR), ISO 13485, and In-Vitro Diagnostic Directive (IVDD) and In-Vitro Diagnostic Regulation (IVDR). In addition, this individual provides guidance to Manufacturing and Operations in navigating the NanoString Quality System.

Requirements:

• BS in Life Science or Engineering discipline

• At least 3 years of experience in the medical device or biotechnology industry

• Experience with product development within a regulated industry

• Hands on experience with Quality Engineering tools such as; Risk Assessment (pFMEA), Root Cause Analysis (5 Whys, FTA, Ishikawa, Pareto, etc.), Process Flow Maps, etc.

• Strong knowledge of design control, change control, process validation and tech transfer, and in-vitro molecular diagnostic manufacturing.

• Working knowledge of Quality System from design control to release of finished product, including FDA 12 CFR 820, ISO 13485, ISO 14971,the EU MDD, CMDR, & IVDD

Essential Responsibilities:

• Support Manufacturing and Operations in navigating the Quality System including SCARS, nonconformances, deviations, change requests, CAPAs, and validations.

• Monitor SCARS, nonconformances, deviations, complaints, and trends to identify and recommend corrective and / or preventive actions.

• Conduct root cause investigations and analyses of issues as assigned.

• Conduct risk assessments for SCARs, nonconformances, deviations, and document changes.

• Provide Quality leadership on process, test method, and equipment validations.

• Work with Supply Chain and suppliers to resolve raw material issues.

• Manage the review and approval of Molecular diagnostic &/or Instrument DHRs (Batch Records).

• Implement appropriate process monitoring and control methods consistent with the level of process/product risk using customer feedback.

• Support customer complaints investigations and supplier audits

• Collaborate with Manufacturing, Manufacturing Engineering, New Product Introduction, Procurement, Quality, and Supply Chain partners as well as vendors on the above activities

• Basic application of statistical tools and methods.

Preferred Qualifications

• ASQ certified or CQE a plus

• Certified auditor a plus

• Experience providing Quality support of molecular diagnostics products

Target Base Salary Range:

$80,000-$110,000

Base salary is an integral part of NanoString's total compensation package. Base salary considers an individual's skills, experience, and competitive market value. The base salary range represent what NanoString pays for a job within a salary grade based on external market data in comparison to similar positions from other companies in our industry. Employees generally enter a salary grade at the lower-to-mid-point in the range.

Base salary is an integral part of NanoString's total compensation package. Base salary considers an individual's skills, experience, and competitive market value. The base salary range represent what NanoString pays for a job within a salary grade based on external market data in comparison to similar positions from other companies in our industry. Employees generally enter a salary grade at the lower-to-mid-point in the range.

Other compensation elements include a discretionary annual bonus, incentive compensation for sales roles, comprehensive benefit plans and paid time off, including designated holidays.

NanoString is an Equal Employment Opportunity and Affirmative Action Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status. NanoString does not accept unsolicited agency resumes and will not pay fees to any third-party agency or company that it does not have a signed agreement with.

COVID-19 VACCINATION REQUIREMENT: NanoString has a COVID-19 vaccination policy that applies to ALL U.S. employees (regardless of work location), onsite contractors and visitors except as prohibited by applicable law. As a condition of employment, newly hired employees are required to provide proof of full vaccination within 31 days of their hiring date or have applied for an exemption for which an accommodation can be made. Being fully vaccinated means that an individual is at least two weeks past their final (or only) dose of an authorized COVID-19 vaccine regimen. Exemptions will be considered for medical conditions/disabilities and sincerely held religious beliefs, observations, or practices. For any visitor coming onsite to one of NanoString's facilities, we must verify that the visitor is fully vaccinated against COVID-19 prior to site entry and visitors must don a face mask at all times when onsite in a NanoString facility.

Accommodations

If you require assistance or accommodation when applying for open positions please contact recruiting@nanostring.com.