Supplier 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 Supplier Quality Manager. Under the VP of Regulatory and Compliance, the applicant will carry out daily activities independently. This position is focused on ensuring that suppliers’ Quality Systems, Policies, and Procedures (SOP’s) for all outsourced processes related to the development and manufacture of Bluejay’s products are compliant with FDA, ISO 3485 and related standards and regulations and with Bluejay policies and procedures.

Responsibilities:

  • Ensure that suppliers have implemented adequate controls, processes and procedures for outsourced processes and that they are maintained to ensure full compliance with current cGMP and global regulatory requirements and alignment with industry best practices.
  • Evaluate supplier performance and quality data sources to identify quality issues and trends, as well as implement corrective and preventive actions to hold suppliers accountable to documented performance improvement plans.
  • Work with the Director of Quality to oversee contract manufacturer (CMO) production processes  record-keeping through batch/lot/serial number release of products to ensure that the records required by FDA (DHR) are sufficient.
  • Perform supplier on-site audits to collect first-hand evidence of the adequacy of supplier processes, procedures and documentation (including record-keeping), training of personnel, provision of resources and self-monitoring by the quality personnel employed by the suppliers.
  • Manage supplier responses related to Corrective and Preventative actions (CAPAs) and Supplier Corrective Action Requests (SCARs)in an effort to identify root causes of quality problems and to implement corrective actions to prevent recurrences.
  • This position requires demonstrated success in working with external suppliers of medical device components (electro-mechanical systems and related software as well as,disposables.)
  • Monitor planned changes to components, software and  supplier management processes to ensure that changes are fully approved and that implementation of changes is closely monitored to quickly identify any quality issues related to the change.
  • Partner with Purchasing and R&D personnel to identify supplier requirements for outsourced components and processes.
  • Represent Bluejay in review of supplier documentation reviews, design reviews, risk assessments and design requirements reviews.

Requirements:

  • Requires a minimum of a technical degree (BS degree in an applied science such as engineering, preferred) and 5-7 years in a medical device quality engineering/quality management role (or MS plus 3-5 years experience), preferably in FDA regulated electro-mechanical devices and related system software
  • Minimum of 7+ years of overall experience in the medical device industry or a closely related industry.
  • Must have excellent written, verbal and presentation skills. Must be able to communicate effectively with all levels of management, both internal and external.
  • Must possess an excellent understanding of medical device quality (cGMP) requirements and ISO 13485 requirements.  Experience with European MDR requirements is a plus.
  • Must have demonstrated experience with Quality Management System, FDA records and electronic document control systems, such as MasterControl or CompliantPro.
  • Experience with software-driven medical devices is critical to success in this role.
  • Requires ability to work with minimal supervision but to also understand and implement management priorities.
  • Strong collaboration and influence skills are essential and must be able to influence their supplier contacts to high levels of performance.
  • Up to 50% travel (domestic and international) to suppliers will be required.  Note that some of Bluejay’s suppliers are located in Japan and regular travel (2-4X per year) will be required.

 Some understanding of principles of Analytical Chemistry is required to support supplier processes, but the right candidate can be trained in this area

Benefits:

  • Medical, Dental and Vision insurance
  • Paid time off
  • Parental leave
  • 401(k) plan with company match
  • Flexible spending account

Industry: Medical Device and In Vitro Diagnostics
Job Type: Full Time

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