- Strong understanding of applicable regulations and standards (21 CFR 803, 806, 820, and ISO
- 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.
- 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.
- 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.
- 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.
- 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.
- GD&T and CMM testing skills is a plus
-
Quality Assurance Associate
1 week ago
NanoString Bothell, United StatesOur 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 Spati ...
-
Quality Assurance Associate
6 days ago
NanoString Bothell, United StatesOur 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 Sp ...
-
Quality Assurance Associate
5 days ago
ELITechGroup Inc. Bothell, United StatesJob Description · Job DescriptionA successful biotech company is looking for a motivated and detail-oriented team member to join our Quality Assurance team. · At ELITechGroup, we are committed to supporting health systems globally. During the Covid pandemic, we played a significa ...
-
Associate Director, Quality Assurance
4 days ago
IQVIA Seattle, WA, United StatesJob Overview:Provide insight which is exercisable across the large part of the organization or by managing a team of managers by influencing outcomes. Oversee & coordinate assigned QA program in support of customer accounts, functional accounts, audit and inspection program, or Q ...
-
Quality Assurance Associate I/II
3 days ago
Access to Advanced Health Institute Seattle, United StatesAccess to Advanced Health Institute is a Seattle-based nonprofit biotech institute that is undergoing a transformation to lead a global coalition to fight infectious disease and address health disparities and inequities worldwide. We think it's unfair that where a person lives or ...
-
Quality Assurance Associate I/II
4 days ago
Unavailable Seattle, United StatesOverview · Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center ...
-
Quality Assurance Associate I/II
6 days ago
Fred Hutchinson Cancer Research Center Seattle, United StatesOverview · Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center ...
-
Quality Assurance Associate I/II
3 days ago
AAHI Seattle, United States Full timeAccess to Advanced Health Institute is a Seattle-based nonprofit biotech institute that is undergoing a transformation to lead a global coalition to fight infectious disease and address health disparities and inequities worldwide. We think it's unfair that where a person lives or ...
-
Kaiser Seattle, United States Full timeJob Summary: · Provide nursing care to a defined group of patients, adhering to Kaiser Foundation Health Plan of Washington ambulatory Nursing Care Standards, the Nursing Code of Ethics and Kaiser Foundation Health Plan of Washington policies. Coordinate and facilitate Health Ca ...
-
Staff Nurse
2 days ago
Kaiser Seattle, United States Full time· Our commitment to our employees goes beyond the workplace, including competitive wages that reflect your value to the company We have recently negotiated new wages, which could include up to 15% increases Apply today to learn more · Job Summary: · Provide nursing care to a def ...
-
Kaiser Seattle, United States Full time· Our commitment to our employees goes beyond the workplace, including competitive wages that reflect your value to the company We have recently negotiated new wages, which could include up to 15% increase with acuity premium and location differentials · Apply today to learn mo ...
-
Kaiser Seattle, United States Full time· Our commitment to our employees goes beyond the workplace, including competitive wages that reflect your value to the company We have recently negotiated new wages, which could include up to 15% increase with acuity premium and location differentials · Apply today to learn mo ...
-
Kaiser Seattle, United States Full time· Our commitment to our employees goes beyond the workplace, including competitive wages that reflect your value to the company We have recently negotiated new wages, which could include up to 15% increase with acuity premium and location differentials · Apply today to learn mo ...
-
Quality Assurance Document Control
1 day ago
Pyramid Consulting, Inc Bothell, United StatesImmediate need for a talented Quality Assurance Document Control (QADC) Associate Specialist. This is a 12+ months Contract opportunity with long-term potential and is located in Bothell, WA(Onsite). Please review the job description below and contact me ASAP if you are int ...
-
Quality Assurance
5 hours ago
Spectraforce Technologies Inc Bothell, United StatesTitle: Quality Assurance Specialist (Pharma ONLY - NON IT JOB) · Duration: 06 Months · Location: Bothell, WA · *Schedule- 9:00pm - 7:30am, Sun - Wed** · **Top Skills: · - 3-5 years of GMP work experience · - Familiarity with Batch Records · - Deviations Experience Preferre ...
-
QA Shop Floor Specialist
1 week ago
Sunrise System inc Bothell, United StatesJob Description: **Schedule- 9:00pm - 7:30am, Sun - Wed** · **Top Skills: · 3-5 years of GMP work experience · Familiarity with Batch Records · Deviations Experience Preferred · Associates or BA Degree preferred, or HS Diploma + relevant work experience · Soft skills inclu ...
-
QA Associate
3 days ago
Ask Staffing Bothell, United States"All candidates must be directly contracted by ASK Consulting on their payroll and cannot be subcontracted. We are unable to provide sponsorship at this moment". · Job Title: QA Associate · Location: Bothell, WA Remote) · Duration: 12 months · Pay rate: $ /hr. on w2 · Job Descrip ...
-
QA Shop Floor Specialist
1 week ago
Sunrise System inc Bothell, United States**Schedule- 9:00pm - 7:30am, Sun - Wed** · **Top Skills: · 3-5 years of GMP work experience · Familiarity with Batch Records · Deviations Experience Preferred · Associates or BA Degree preferred, or HS Diploma + relevant work experience · Soft skills include- strong cross- ...
-
Quality Assurance Assistant
1 week ago
Career Management Group Bothell, United StatesCareer Management Group is looking for a Quality Engineering Technician to support the Supplier Quality & Manufacturing Quality teams and complete essential quality activities. This is an approximately 6-month contract position with an ASAP start date. · As a Quality Engineering ...
-
Quality Assurance Assistant
2 hours ago
Career Management Group Bothell, United StatesCareer Management Group is looking for a Quality Technician to support the Supplier Quality & Manufacturing Quality teams and complete essential quality activities. This is an approximately 6-month contract position with an ASAP start date. · As a Quality Engineering Technician, ...
Quality Assurance Associate - Bothell, United States - NanoString
Description
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 CosMxTM 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:
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:
$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
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
