Software Quality Engineer (ADX-241-20)

| Greater Boulder Area
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Software Quality Engineer (ADX-241-20)
 

THE COMPANY: ArcherDX, Inc. - www.ArcherDX.com

 

ArcherDX is advancing molecular diagnostics with a robust technology platform for genetic mutation detection by next-generation sequencing. By combining patented Anchored Multiplex PCR (AMP™) chemistry in an easy-to-use, lyophilized format and powerful bioinformatics software, the Archer® platform enhance genetic mutation identification. ArcherDX provides oncology-focused research products and is pursuing regulatory approval for multiple companion diagnostic assays. ArcherDX is headquartered in Boulder, Colorado. Learn more at www.archerdx.com and follow @ArcherDXInc on Twitter, Facebook and LinkedIn. 

 
POSITION SUMMARY:
 
The Software Quality Engineer will support software Infrastructure for Product and Non-Product software, automated manufacturing test and clinical data collection and analysis will be responsible for performing software quality roles for authoring, testing, organizing, and supporting software compliance to ensure goals and objectives are being met. Post market product software maintenance and change control will also be supported. This position will serve as a subject matter expert on Archer’s product and non-product software risk based design lifecycle, non-product software tool documentation, cybersecurity and data privacy compliance. This position is expected to implement author software quality documentation, interface and collaborate with non-product software suppliers for custom developed software infrastructure systems for Archer.
RESPONSIBILITIES:
  • Support product and non-product software projects to continuously evaluate compliance, validation efforts, and effectiveness.
  • Interface with functional department leads to identify product and non-product software gaps, improvements, and oversee the validation and software performance to insure the product and non-product software and processes meet quality requirements/standards.
  • Execution will include collaborating, via review and authoring of documents, with Archer’s product and non-product software used to support product verification, manufacturing, process validation, clinical data collection/data management and in the creation of software documentation to support validated software design, development, verification and review by regulatory authorities. Where appropriate, interface with external resources, such as consultants, on key initiatives with management on timelines, costs and execution. 
  • Support product and non-product software risk assessment, cybersecurity design considerations, development of software user needs and requirements, validation test protocol authoring and execution, and software configuration management.
  • Support product and non-product software execution of validation supporting IT infrastructure such as Archer’s MES, ERP, eQMS software, clinical data collection systems & analysis software, and clinical data storage. Work with key stakeholders among Archer’s IT, data management and clinical teams and support validation of data integrity, security, audit readiness, privacy (HIPAA, GDPR, etc.), data retention, storage and recovery. Support improvement of Archer’s quality and compliance for product and non-product software and tools
  • Assess Archer’s infrastructure needs to create and execute and validation planning to ensure proper support for Archer’s non-product software and infrastructure needs.
  • Support product and non-product software audits, as a subject matter expert, when working with external business partners and regulatory authorities. When assigned findings for closure, demonstrate accountability and a commitment to continuous improvement by resolving issues.
  • Perform other duties as assigned by supervisor.
 
EXPERIENCE:
  • Minimum of 3 years in software testing to support software used in a regulated industry, with 3 or more years of experience in software quality assurance and/or software tool validation.
  • Demonstrable experience in performing software risk assessment, software validation & testing. Good technical writing skills with hands-on experience authoring, peer-reviewing and defending software documentation for non-product, test data infrastructure and non-product tools.
  • Ability to speak and defend software validation documentation to external auditing authorities.
  • Certifications, such as ASQ, in quality assurance preferred.
  • Ability to interact with multiple disciplines and communicate clearly and effectively verbally and in writing.
  • Ability to work independently and utilize good problem-solving skills.
  • Ability to multitask and work within a fast-paced dynamic team environment. Archer is interested in a subject matter expert who will build collaboration among key departments rather than define functional boundaries.
  • Desired experience and standards knowledge for the following: 21 CFR Part 11, ISO 13485, ISO 14971, 62304, GAMP, GDPR, HIPAA, Cybersecurity
EDUCATION:
  • Minimum B.A. or B.S., preferably in engineering or other technical discipline
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Technology we use

  • Engineering
    • JavascriptLanguages
    • PythonLanguages
    • RLanguages
    • D3JSLibraries
    • jQuery UILibraries
    • Twitter BootstrapLibraries
    • DjangoFrameworks
    • PostgreSQLDatabases

Location

Conveniently located minutes from downtown Boulder via Pearl Street or the Goose Creek Path. Easily commutable from all directions.

An Insider's view of ArcherDX

What’s the vibe like in the office?

Collaborative - when I walk through the ArcherDX office at any time of day, I can see cross-functional collaboration in action. Our team members are constantly connecting in structured and unstructured meetings to solve problems and achieve goals.

Sarah

Corporate Recruiter

How do you collaborate with other teams in the company?

Collaboration between functional groups is key to the Logistics team's success at Archer. Working closely with Sales, Manufacturing, Assay Development, Customer Support, Finance and QA allows us to provide better customer service by improving our processes, troubleshoot, brainstorm new ideas, learn from each other and share our best "dad" jokes.

Judy

Logistics Manager

How do you empower your team to be more creative?

Creativity requires a break from the routine and the screen. Here at Archer the team gets creative through walks to the food trucks, lunch runs, climbing gym sessions or a few end of the week craft brews. Some of our best algorithms were developed or refined on the climbing gym mat.

Aaron

VP of Bioinformatics and Commercial Development

How do your team's ideas influence the company's direction?

The marketing team brings in and drives the voice of our customers across the organization. Each strategic decision we make at ArcherDX is informed by a deep, customer-centric approach, where we use our insights to better understand how we can deliver an exceptional experience and aim to positively impact the lives of the patients we serve!

Ali

Director, Global Marketing

What are ArcherDX Perks + Benefits

ArcherDX Benefits Overview

ArcherDX offers a competitive and generous benefit package including:

• Medical PPO or HMO and Dental-82% of monthly premium covered by the company
• Optional vision, life, FSA, dependent care plans
• Basic AD&D, Short and Long Term disability-covered 100% by the company
• 160 hours PTO per calendar after three months of service
• 6-weeks parental leave covered 100% by the company
• 401K with company match with potential of up to $2000/year
• 2019 bonus - 5% based on company objectives (for non-commissioned employees)
• Company stock options for all employees
• Tuition Reimbursement
• Ecopass

Culture
Volunteer in local community
Partners with Nonprofits
Friends outside of work
Eat lunch together
Daily stand up
Open door policy
Team owned deliverables
Team based strategic planning
Group brainstorming sessions
Diversity
Documented equal pay policy
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Disability Insurance
Dental Benefits
Vision Benefits
Health Insurance Benefits
Life Insurance
Wellness Programs
Retirement & Stock Options Benefits
401(K)
401(K) Matching
Company Equity
Child Care & Parental Leave Benefits
Generous Parental Leave
Remote Work Program
Our remote work program includes work from home on occasion as needed.
Family Medical Leave
Employees who have been with the company for 12 months are eligible for 12 weeks of family medical leave.
Company sponsored family events
Archer sponsors family oriented events annually. This year, we had our summer picnic at the Boulder Reservoir.
Vacation & Time Off Benefits
Generous PTO
Paid Holidays
Perks & Discounts
Beer on Tap
Casual Dress
Commuter Benefits
Company Outings
Archer hosts company outings Semi-annually.
Relocation Assistance
Professional Development Benefits
Job Training & Conferences
Tuition Reimbursement
Our tuition reimbursement plan offers an annual max of $5250.
Cross functional training encouraged
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