Quality Assurance Associate

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.

Summary:

The Quality Assurance Associate II is responsible for supporting the NanoString Quality Management System (QMS) process. Primarily responsibilities will include creating and modifying standard operating procedures, Quality Assurance (QA) product release, administration of change management and document control processes, and auditing. Ensure consistent implementation, improvement, and compliance to the NanoString Quality System and global regulatory requirements, including, but not limited to, the FDA Quality System Regulation (QRS), Canadian Medical Device Regulatory (CMDR), ISO 13485, and In-Vitro Diagnostic Directive (IVDD).

Requirements:

Minimum Education: Bachelor's degree in a related field strongly preferred.

Minimum Experience : 3-5 years quality-related experience in the pharmaceutical or device industry.

Specialized Knowledge:

• Strong understanding of applicable regulations and standards (21 CFR 803, 806, 820, and ISO 13485).

• Problem Solving and training skills.

• Practical experience/training in quality systems management, change management and document control processes, quality auditing, root cause analysis, and problem-solving are highly desirable.

Responsibilities:

• Administer the Change Management and Document Control system.

• Perform QA product release.

• Lead creation and modification updates for SOPs, work instructions, and other quality documentation.

• Review quality records for completeness and compliance with QSR and ISO requirements.

• Assist Quality Management with various projects, as required

• Support the eQMS electronic documentation system, as needed

• Conduct, participate and support internal quality audits, process/product improvement projects, and disposition activities

• Participates in FDA inspections and customer audits

• Perform other relevant duties as may be assigned by management.

Skills and Abilities:

• Analytical decision-making skills to apply logical or scientific thinking principles to a wide range of intellectual and practical problems.

• Good knowledge and skills in using advanced personal computer productivity programs for word processing, spreadsheets, database manipulations, and flow charts.

• Demonstrates working knowledge of ISO 13485 quality system and/or FDA 21 CFR 820 quality regulations.

• Good written and verbal communication skills.

• Interpersonal skills to interface with all levels of the organization, management, customers, and suppliers.

• Lead Auditor certification

• Experience in the medical device or diagnostic industry, a plus.

The Quality Control Inspector II (QCI) is responsible for initial Quality Control inspections of all NanoString incoming raw materials, components and sub-assemblies received at our facilities per inspection plan. QCI is also responsible for all finished instrumentation testing of all final assembled instruments per inspection plan.

The scope of this position is includes performing all necessary quality control checks, including FAIRs (First Article Inspection Reports), using appropriate testing procedures and test instrumentation supported with appropriate documentation for all Nanostring products to manage quality risk and provide oversight over manufacturing processes.

This position reports into the compliance and certifications manager which is part of Quality organization. The 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).

Requirements:

• Technical diploma or equivalent BS in technical discipline with hands-on experience in a regulated industry.

• At least 3 years of experience as a QC inspector in a regulated environment i.e., medical device/ biotechnology/ aerospace industry.

• Analytical and creative problem-solving skills that include experience in leading and or participating on process improvement/lean projects.

• Excellent written and oral communication skills.

• Ability to work independently and collaboratively in cross-functional teams.

• Ability to multi-task with demonstrated problem solving skills in a fast-paced complex environment.

• Proficient in use of MS Office.

Essential Responsibilities:

• Perform incoming and final quality control inspections to support Manufacturing and Operations quality for all NanoString instruments following latest Incoming Specifications

• Update incoming inspection specifications and procedures as required, in collaboration with other affected departments.

• Record non conformances and support in conducting root cause investigations.

• Manage nonconforming (or potentially nonconforming) material through disposition.

• Perform lot validation testing while monitoring and adjusting testing frequencies.

• Support review and updating of SOPs relating to Quality Control Procedures.

• 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 Qualification

• GD&T and CMM testing skills is a plus

Target Base Salary Range:

$62,000-$85,000

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.

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.

Accommodations

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

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.