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Operations and Compliance Officer
3 weeks ago
We are seeking a highly skilled Operations and Compliance Officer to join our team at Demant Polska. In this role, you will be responsible for ensuring the highest level of quality and compliance in all aspects of our operations. You will work closely with cross-functional teams to identify and implement process improvements, manage inventory and logistics, and maintain accurate records. If you have a passion for quality assurance and a knack for attention to detail, we encourage you to apply for this exciting opportunity
Responsibilities:
- Inventory Management: Coordinate and support inventory control, logistics, and supply chain processes to ensure operational goals align with quality and regulatory requirements.
- Regulatory Compliance: 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.
- Process Improvement: Stay up to date on regulatory procedures, standards, and changes in the regulatory climate and execute Year-End Inventory Audit and Annual Interim Audit to maintain accurate inventory records.
- Audit Participation: Participate in external regulatory agency audits as required and monitor Data Governance dashboard and investigate/assign tasks to ensure data accuracy in ERP systems.
- Reporting: Assist in the development of KPI reports, such as weekly team reports and quality objective reports and review product labels and promotional material for compliance with applicable regulatory requirements.
- Dispute Resolution: Investigate and resolve customer and supplier disputes, including claims and quality issues in conjunction with Client Services.
Requirements:
- 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.