Operations and Quality Assurance Specialist

We are seeking an experienced Operations and Quality Assurance Specialist to oversee and optimize quality activities for a manufacture of medical devices, assuring compliance with applicable medical device regulations, guidance and standards.  The ideal candidate will be detail-oriented, proactive, and possess excellent organizational and communication skills

Key Responsibilities

• Coordinate and support inventory control, logistics, and supply chain processes to ensure operational goals align with quality and regulatory requirements.
• Maintain and ensure the accuracy of QMS procedures, QM documents, job descriptions, and training records to demonstrate compliance with medical device regulations and reporting requirements.
• Stay up to date on regulatory procedures, standards and changes in regulatory climate.
• Execute Year-End Inventory Audit and Annual Interim Audit to maintain accurate inventory records.
• Participate in external regulatory agency audits as required.
• Monitor Data Governance dashboard and investigate/assign tasks to ensure data accuracy in ERP systems.
• Assist in the development of KPI reports, such as weekly team reports and quality objective reports.
• Review product labels and promotional material for compliance with applicable regulatory requirements.
• Investigate and resolve customer and supplier disputes, including claims and quality issues in conjunction with Client Services.
• Update and communicate with the Operations Manager regarding Quality Manual/MDEL process additions and changes.
• Support other projects as required.

Qualifications

• Minimum of 1+ year of experience in a quality role with experience in quality management systems/MDEL and regulatory requirements, ISO within a manufacturing or distribution environment, preferably in medical devices.
• Proficiency with MSOffice (Excel, Outlook, etc.) ERP systems, MS Dynamics and Salesforce.
• Strong analytical skills with the ability to identify trends and make data-driven recommendations.
• Excellent communication and interpersonal skills with the ability to collaborate effectively with internal teams and external suppliers.
• Detail-oriented with strong organizational and problem-solving abilities.
• Ability to multitask and prioritize tasks in a fast-paced environment.

Why should you work with us?

• Competitive salary with annual reviews
• Excellent medical benefits: including dental, vision, health, Employee Assistance Program
• Fitness/Exercise spending account
• 3 weeks vacation
• Dynamic work atmosphere
• Career development programs and opportunities