Quality Manager

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Description:

Bluejay Diagnostics is a medical diagnostics company focused on developing cost-effective, rapid, near-patient products for triage and monitoring of disease progression. To help us with our mission, we are searching for Quality Manager. Reporting to the VP, Regulatory and Compliance, the successful candidate will ensure effective implementation and maintenance of Bluejay’s Quality Management System (QMS), including the Quality Policy and Operating Procedures, Work Instructions, Records and Training for our In Vitro Medical Device manufacturing organization, including the Analytical Laboratory and for all outsourced processes. The Quality Manager will be responsible for all aspects of Bluejay’s QMS and will perform the responsibilities of Management Representative.

This role requires that the Quality Manager is data-driven in their decision making, detail oriented, effective in leading as well as following and experienced with FDA-regulated quality systems for the design and manufacture of In Vitro Diagnostic Devices (IVD’s). A thorough knowledge of 21 CFR Parts 820, 801, 803 and Part 11 as well as ISO 13485 requirements in an IVD environment is essential.

The successful candidate must have significant experience with Quality System audits (FDA and ISO 13485) as an auditor and an auditee. This role provides inputs to the management of external suppliers by working with Bluejay’s Supplier Quality Manager and technical consultants in-country. Some travel, including overseas travel should be anticipated. Experience with an electronic QMS system such as MasterControl or CompliantPro is critical to success.

Responsibilities:

  • Report on the effectiveness of the QMS at regular intervals and monitor, identify and anticipate quality trends so that effective actions can be taken before they impact customers or the patients that are served by our devices.
  • Responsible for the effectiveness of CAPA and Complaint/Feedback processes.
  • Ensures quality system processes are kept current.
  • Ensures compliance with the organization’s policies and all applicable national (FDA 21 CFR Part 820) and international quality standards and regulations (i.e. ISO) regarding Medical Device QMS’.
  • Works with R&D, Manufacturing, Product Support, Sales, Suppliers, and Consultants to improve product quality to meet current cGMP as well as Bluejay requirements.
  • Periodically report to management on key metrics related to the effectiveness of the QMS.
  • Identify improvement opportunities and implements applicable changes in a controlled manner.
  • Perform other duties as assigned.

Requirements:

  • College degree (BS/MS) in a technical/scientific field (Engineering is highly desirable).
  • Minimal BS and 5+ years or MS plus 3 years Quality Management experience with a medical device manufacturer (IVD manufacturer is desirable).
  • Experience with electronic Quality Management Systems / Experience with MasterControl a plus.
  • Strong knowledge of ISO standards and FDA regulations/guidance as they apply to medical devices.
  • Ability to understand technical details in design and manufacturing of electro-mechanical, software-driven medical devices.
  • Must possess excellent written and verbal communication skills, interpersonal, and problem-solving skills.
  • Excellent ability to collaborate to achieve objectives and problem-solve.
  • Detail-oriented with the ability to work independently as well as collaboratively in a team setting with peers and colleagues in a cross functional setting.
  • Must be self-starter, able to prioritize and handle multiple tasks and ability to meet strict deadlines and perform under pressure in a fast-paced work environment.
  • Excellent skills in Excel, PowerPoint, Word.

Benefits:

  • Medical, Dental and Vision insurance
  • Paid time off
  • Parental leave
  • 401(k) plan with company match
  • Flexible spending account
  • Disability
Industry: Medical Device and In Vitro Diagnostics
Job Type: Full Time

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