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Quality Engineer II/III (Production/Manufacturing QA)

Company: Invitae
Location: Boulder
Posted on: May 3, 2021

Job Description:

Invitae is dedicated to bringing comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Our team is driven to make a difference for the patients we serve. We are leading the transformation of the genetics industry by making genetic testing affordable and accessible for everyone to guide health decisions across all stages of life.

POSITION SUMMARY:

The Quality Engineer II/III (Production/Manufacturing QA), reporting to the Manager, Manufacturing Quality Operations - IVD, will support tech transfer, production scale-up, and Quality operations activities for In-vitro Diagnostic (IVD) product development, and implement the Quality Management System (QMS) to ensure ArcherDX medical devices are manufactured under FDA GMP and ISO 13485 regulations. The Quality Engineer II/III will also be tasked with developing quality processes in a high-throughput Manufacturing environment, investigating quality issues, and implementing continuous improvement activities to ensure that production rates are scalable while maintaining Quality standards.

RESPONSIBILITIES:

Job performance will involve a variety of activities including:

  • Serves as the process Quality Engineering representative on new product development and tech transfer projects, and provides strategic Quality representation across teams.
  • Influences across Quality System functions, including, but not limited to, design, production, assay development, document control, risk management, etc.
  • Develops, implements, and evaluates tools, systems, and methods for product/process improvement and conformance.
  • Applies Lean/Six Sigma principles to identify and implement improvements in a rapidly-growing GMP manufacturing environment to increase capacity, reduce lead-time, and improve process flow.
  • Collaborates between Development and Production teams to ensure that Quality and Lean are built into manual and automated processes.
  • Provides technical guidance and quality compliance for multiple areas of the quality system to ensure process and product quality.
  • Identifies and supports quality test methods, inspection criteria, risk assessments, and other processes for new products to ensure compliance to regulatory standards.
  • Perform other duties as assigned by supervisor
  • Review, understanding, and compliance with ArcherDX HIPAA Security policies and procedures.
  • Safeguarding the privacy and security of protected health information and European Union personal data.
  • Processing and handling of European Union personal data only as directed by ArcherDX for purposes of personalized molecular pathology.

EXPERIENCE:

  • Minimum of 5 years of Quality experience in an FDA-regulated environment
  • Minimum Lean/Six Sigma Green Belt certification, preferred
  • Recommended ASQ CQE certification, or similar
  • Expertise in Quality System requirements, including ISO13485 and 21CFR820
  • Ability to communicate and influence cross-functionally
  • Ability to apply Lean/Six Sigma and Quality Engineering principles in product development and tech transfer processes
  • Attention to detail with a strong ability to create and review technical documentation
  • 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

KEY ATTRIBUTES:

  • Drive and determination
  • Ability to work in a fast paced and dynamic environment
  • Ability to participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance the success of the projects and maintain strong relationships within all parts of the company.
  • Strong communication and presentation skills
  • Self-starter
  • Driven to perform
  • Self-directed: needs little explicit direction
  • Able to organize, prioritize, and delegate tasks to efficiently move projects forward.

EDUCATION:

  • Bachelor's degree in an Engineering or Scientific field

In Colorado, our competitive compensation package includes a base salary starting from $85,000. In determining the final salary offered, we will evaluate a specific candidate's geographic location, education, skills, and experience.

Invitae offers a competitive total rewards package, which includes healthcare coverage, 401k, and a broad range of other benefits, outlined below:

  • Health, dental, vision, short- and long-term disability, and basic life insurance coverage
  • Paid time off, holiday pay, parental leave, and other health and wellness supports

At Invitae, we value diversity and provide equal employment opportunities (EEO) to all employees and applicants without regard to race, color, religion, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance.

Keywords: Invitae, Boulder , Quality Engineer II/III (Production/Manufacturing QA), Other , Boulder, Colorado

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