You will work with the direction of the Quality Assurance Manager as an integral part of the new Development team in a fast-paced environment to develop and bring to market molecular diagnostic tests for detection of circulating tumor DNA in blood. This team supports the existing commercial test (Colvera TM) and is also responsible for the improvement & development of current and new tests, respectively.


Position Summary

The Quality Design Assurance Engineer is responsible for promoting and driving effective utilization of Design Control and Risk Management processes in support of organizational goals and objectives.


Essential Responsibilities

  • Partner with R&D to optimize Design Control process and Sustaining Quality Engineering processes. Serve as the Design Control Subject Matter Expert for the Quality Department to the organization. Partner with R&D to develop and deliver Design control training for organization.
  • Partner with R&D to actively participate in all phases/activities of design and process control project(s) for medical device products including design review, design transfers, and in all aspects of the Design Controls process for new products. Review and approve Design Control documents, protocols and reports.
  • Lead or participate in implementation of new product design assurance: including Risk management (per ISO 14971), User, Design, and Process FMEAs, requirements traceability matrices, design verification and validation, etc. Utilize statistical analysis techniques to determine product acceptance.
  • Lead or participate in the design, development, optimization, and validation of test methods and inspection procedures. Guide/author design verification and design validation protocols and reports.
  • Support DMR and DHF compliance assessments to ensure quality and regulatory requirements are successfully implemented and maintained. Support Sustaining Engineering for design and process changes to commercialized product.
  • Fully support the Quality Policy by building quality into all aspects of the incumbent’s work and by maintaining compliance to all quality requirements (including but not limited to being current on all training requirements for the incumbent’s position and documenting that training).
  • Support activities associated with agents of regulatory bodies as necessary to demonstrate quality system compliance. Support Certification/ recertification activities for US, European and other markets. Assist with drafting of documentation to support regulatory submission activities and review content for compliance to QSR regulations.
  • Up to 20% travel required (domestic and international)
  • Conduct must reflect the Company’s values and a commitment to the Code of Conduct ethics and compliance program.
  • Other duties as assigned by Supervisor.

 

Qualifications:


  • Authorization to work in the US indefinitely without restriction or sponsorship.


Education/Experience:

  • Bachelor’s degree in a scientific or technical discipline such as Chemical Engineering, Process Engineering, Biomedical Engineering, or similar field. Master’s degree preferred.
  • ASQ certification is preferred
  • 3+ years of related Quality Engineering experience
  • Prior pharmaceutical or medical device design and development experience required, IVD experience preferred and companion diagnostics experience is a plus.
  • Demonstrated ability to act as Subject Matter Expert related to Design Controls, Device History Files, Master Validation Plans, UFMEAs, DFMEAs and PFMEAs, including experience in development and utilization of design control systems and familiarity with structured phase-gate product development processes.
  • Strong Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820), ISO 13485 Medical devices – Quality management systems, and ISO 14971 Medical devices – Application of risk management to medical devices and other international standards and regulations.
  • Demonstrated experience organizing and maintaining large documentation sets.


Skills/Knowledge/Cultural Fit:  

  • Demonstrates strong written and verbal communication skills
  • Fosters and enables innovation
  • Displays dynamic leadership by being assertive and promoting ideas while building consensus
  • Promotes teamwork by working collaboratively and closely with others, internally and externally
  • Drives execution of action plans by addressing issues in a transparent and effective way.
  • Displays agility and flexibility by quickly adjusting to new information in a fast-changing environment
  • Strong collaboration, problem solving and analytical skills
  • Professional and team-oriented interpersonal communication skills
  • Ability to follow up with task owners to close out open items.
  • Highly detail oriented with disciplined and effective time management, scheduling, and organizational skills
  • Strong knowledge of and experience in applying data analysis and statistical techniques to product/process design and operational activities
  • Must be analytical, flexible, innovative, and self-motivated
  • Must have the flexibility in work arrangements to meet departmental goals
  • Thrive on opportunity to excel and contribute