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Quality Assurance Manager

Diabetomics, Inc.
Hillsboro, OR Full Time
POSTED ON 1/16/2025
AVAILABLE BEFORE 3/14/2025

About us:

Diabetomics, Inc. is a leading medical diagnostics company serving the needs of personalized health and diabetes risk assessment and management. Diabetomics Inc. is currently seeking a Quality Assurance Manager to join our established team. Essential Functions: Maintain quality assurance throughout the organization, improving quality processes while maintaining or improving efficiencies.

Responsibilities:

* Maintain the QMS in compliance with ISO 13485, EU IVDR, and 21 CFR 820.

* Act as the primary liaison between management, R&D and vendors on quality issues.

* Own the Supplier Quality Management Program. Work with supply chain regarding contract manufacturers and suppliers to improve quality through pre-qualification reviews, on-going oversight and audit, implementation of engineering changes and other procedures.

* Ensure R&D design processes and manufacturing processes are conducted in compliance with the Corporate Quality Plan and ensure validation and testing protocols are robust. Instill an emphasis on designing and testing for quality within the manufacturing and development activities.

* Administer the Management Review process. Recommend KPI’s to measure compliance with quality standards and effectiveness of corrective actions across all functions.

* Manage Calibration, NCMR, CAPA, Complaint, Training, and Internal Audit programs.

* Review controlled SOP, QCF, PMS, FRM and other Quality System documents.

* Manage the Change Order system.

* Manage Device Master Files, including Design History Files, Device Master Records, Device History Records, and Risk Files.

* Conduct Quality System Audits (including international audits) and ensure that corrective action is performed.

* Maintain and update, as necessary, the Corporate Quality Plan, develop and deliver training to ensure organization understands and embraces quality procedures and verify on-going compliance with quality procedures.

* Ensure that all team members are trained in the Quality System.

* Assist in providing documentation as needed for world-wide regulatory submissions.

Experience:

* 3-5 years of related experience. Prefer prior IVD production management experience, or knowledge of medical device regulations (EU IVDR, QSR, ISO 13485, ISO 14971, ISO 9001, etc.).

* Strong computer skills including Microsoft Office and databases

* Knowledge of relevant worldwide regulatory requirements

* Experience with HIPAA and GDPR Regulations and implementation to the organization

* Experience with IVD Clinical trials, in particular Point-of-Care

* The ideal candidate will possess strong quality assurance knowledge, good analytical skills, excellent communication skills, a collaborative style, the ability to influence quality both within and outside the organization and a strong focus on the customer

Job Type: Full-time

Pay: $60,000.00 - $80,000.00 per year

Benefits:

  • Dental insurance
  • Flexible spending account
  • Health insurance
  • Paid time off
  • Vision insurance

Schedule:

  • 8 hour shift
  • Day shift
  • Monday to Friday

Application Question(s):

  • How many years experience do you have in FDA / IVD regulation?

Experience:

  • medical device: 3 years (Required)

Ability to Commute:

  • Hillsboro, OR 97006 (Required)

Ability to Relocate:

  • Hillsboro, OR 97006: Relocate before starting work (Required)

Work Location: In person

Salary : $60,000 - $80,000

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