Nov 23, 2021

Quality Engineer (Commercial)

  • Sense Biodetection Inc
  • Remote (Milford, MA, USA)
Full time Quality

Job Description

Company

Sense is transforming healthcare by redefining diagnostics. Our Veros™ instrument-free molecular platform empowers doctors and patients by delivering diagnostic results that can be trusted, in a way never thought possible.

Backed by some of the most respected venture capital firms in the world, we are a rapidly growing Company that is launching an entirely new class of diagnostic product: a rapid, disposable, instrument-free molecular product platform delivering the “gold standard” performance of laboratory testing without the constraints of costly instruments or readers.

We believe our approach enables better access, better outcomes, and better value across every aspect of healthcare.  Sense is aggressively growing from its strong research and development foundation and emerging as the global leader in this exciting new segment of healthcare.

 

The purpose and scope of the role:

This role will be responsible for the management of the Quality Management System, with a focus on the commercial quality elements whilst supporting the Commercial and Distribution organisations through the deployment and adoption of quality procedures, instructions and guidance. 

Key Responsibilities:

  • Support the implementation, optimisation, and training of the QMS at all sites across the wider organisation
  • Provide guidance and support across the wider organisation on ISO13485 and/or FDA 21 CFR 820 requirements
  • Implement and maintain metrics for the continued compliance monitoring and improvement of the QMS (aligned to company objectives)
  • Lead the day-to-day management of the Quality Management System focused on commercial quality elements
  • Support the establishment and maintenance of customers and distributors in accordance with the QMS
  • Provide guidance and support to all key commercial stakeholders on product and process quality issues
  • Provide support to the generation and evaluation of product test data to support product development and continuous improvement
  • Manage and co-ordinate product release prior to distribution
  • Manage and drive solutions through Post Market Surveillance and CAPA for in-market product complaints
  • Provide quality support and guidance to all the commercial quality organisation
  • Provide device quality representation during customer/regulatory body visits/audits

Qualifications:

  • Bachelor’s degree or higher qualification in a scientific, engineering or medical discipline
  • Applicable certificates (e.g., Internal auditor, 21 CFR part 11 compliance and CSV) preferred
  • ASQ certification as a quality engineer (ASQ CQE) or equivalent
  • ISO 13485 internal auditor certificate

Experience:

  • Experience of management of complaints from intake through to investigation and reporting
  • Storage, Handling and Distribution procedures deployment experience
  • Working with European colleagues
  • Experience with ISO 14971 and 17025 standards preferred
  • Statistical analysis and trends reporting

Knowledge:

  • Nonconformance and CAPA management
  • 21 CFR part 820 knowledge
  • Advertising & promotional materials controls
  • 21 CFR part 11
  • Computer systems validation management

Skills:

  • Independent worker
  • Collaborative attitude
  • Exceptional training skills to convey quality concepts
  • Prior use of Greenlight Guru eQMS
  • Strong communicator with good written skills and a focus on attention to detail and problem solving
  • Confident and a proactive team-player, who can think on their feet and prioritise their own workload effectively

Benefits

  • Healthcare
  • Competitive Salary
  • Annual Leave
  • Share Option Scheme
  • 401(k) with company match

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