QA Medical Complaints Handling Manager

Alcon Polska Sp. z o.o.

Warszawa, Poland

1 d. temu

Job Description

Alcon is the global leader in eye care, dedicated to helping people see brilliantly. With our 70-plus-year heritage, we are the largest eye care device company in the world with complementary businesses in Surgical and Vision Care.

Being a truly global company, we work in over 70 countries and serve patients in more than 140 countries.

Alcon Global Services (AGS) is a dynamic team providing critical shared-services support to the Alcon organization worldwide in areas like Finance, IT, HR, Quality, and more.

Our objective in AGS is simple ensuring the satisfaction of our internal clients and contributing to an outstanding experience for Alcon’s customers worldwide.

Join Alcon and help the world See Brilliantly!

The Medical Complaints Handling Manager is responsible for managing all elements of the quality technical complaints and adverse event day to day processes including intake, follow up, triage and system entry necessary to comply with local and international regulations, guidelines, and applicable directives

Help develop and execute strategies for Complaint handling in EMEA and serve as a partner with the affiliates and distributor markets to best support internal and external customers in relation to product complaints.

Responsible for managing vigilance operational process in order to follow deadlines of Health authority submissions, ensuring compliance with Alcon global / local procedures

How you will make a difference :

Create and maintain a high performance collaborative QAMC team with focus on customer needs and compliance to handle complaints from the EMEA region.

Engage and motivate QAMC intake team through adequate training and effective communication, providing feedback to direct reports through one to one discussions, performance reviews, recognition and coaching

Manage data collection, data entry, processing, documentation, reporting and follow-up of all technical product complaints and adverse event (AE) reports for all Alcon products from healthcare professionals (HCPs), patients, internal Alcon personnel, clinical trials, non-interventional studies, customer oriented marketing programs (COMPs), literature, spontaneous reports, etc.

in a timely manner per SOPs, regulations and directives

Review potential complaint data received via safety system(s), service records, Alcon's website, CRM system, and other methods, as required.

Escalate potential safety issues, emerging trends and / or concerns as appropriate.

Assist with triages from all sources for quality technical complaint, Adverse Event, request for refund, request for replacement product and request for credit.

Engage in, lead or support as appropriate, process improvement initiatives or projects to enhance the complaints process.

Acts as delegate for Regional Director for Complaints handling as needed.

Maintain a substantial and thorough knowledge of company policies and procedures, departmental processes, and associated work instructions, evolving local and international regulations, guidelines and applicable directives in relation to complaint handling.

Lead audit preparation activities, facilitate, manage and close out any audit findings, ensuring all corporate requirements are met and robust CAPAs implemented.

Ensure continual Quality System Compliance by adherence to established and evolving Alcon and regulatory requirements.

Responsible for creating and maintaining regional training and knowledge base materials.

What we can offer you :

Opportunity to work on best in class Organization among Medical Devices / Equipment sector

Opportunity to work in a high paced agile environment

Work with people who are passionate of delivering outcomes and a culture of simplification and ownership

Possibility to influence the design of the solution responding to business needs to enhance customer experience

Collaboration and frequent direct interactions with business stakeholders

Truly international environment and daily interactions with colleagues from all over the world

Attractive benefits package (private medical care, group insurance, lunch card, transportation allowance, pension plan, Multisport / cultural card, free Alcon products for you and your significant other

Permanent employment contract, attractive base salary and annual bonus

Flexible hours and remote work possibilities

Brand new office in Marynarska 15, Warsaw, with a lot of facilities inside

Skills for success :

Bachelor degree

Master degree or higher, technical of life science background is preferred

2 year of experience in Customer service, complaints handling, quality management system or similar

Experience as a direct people manager

Fluent in English both spoken and written is a requirement. Minimum of B2 (CEFR) proficiency when covering also local language communications.

Computer literacy with standard software platforms

Effective communicator and ability to work with a variety of departments and regulatory bodies.

Demonstrates the Company’s Values and Behaviors

Quality and focus oriented

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