Complaints Manager

Job Description:

• Responsible for the management of complaint unit employees and serves as the primary point of contact for all customer complaints worldwide related to our medical device products, ensuring a prompt and customer-focused response.
• Maintain a thorough and compliant complaint handling system, aligning with 21 CFR Part 820 requirements (and others), to ensure that all complaints are documented, investigated, and resolved according to established SOPs and regulatory guidelines.
• Manage the complaint life cycle including data gathering from customers, overview the complaints investigation process, coordinate with cross-functional teams to understand the underlying issues.
• Support processes of corrective and preventive actions (CAPA) stemming from complaint investigations and monitor the effectiveness of these actions.
• Prepare and present complaint trends for management review meetings, highlighting potential risks and areas for quality improvements.
• Write and update complaint procedures and work instructions to maintain an up-to-date knowledge base on the latest complaint handling regulations, industry best practices, and continuous improvement processes.
• Write, review, and approve complaint documentation including customer response letters.
• Decide on MDR/Vigilance complaints reporting and review decisions made by complaint unit employees.
• Ensure the integration of the complaint handling process with other quality system players (e.g., risk management, R&D, production, engineering)
• Represent the complaint aspects during internal and external audits.

Education: BSc in Engineering or practical engineer – life sciences – advantage

Job skills:

• Ability to work with cross-functional teams and to interact effectively with peers, management members and customers.
• Knowledge of Medical Device Quality Assurance requirements – advantage.
• Analytical skills-must.
• Technical orientation.
• Familiarity with SAP/Salesforce– advantage.

Computer skills:

• Full control of all MS-Office applications.

Language skills:

• Fluent English – writing and verbal.

Personality:

• Very high interpersonal capabilities, assertive and collaborative ability to work in multidisciplinary work opposite various stakeholders internally and externally.
• A team player.
• Organized, paying attention to the small details.