Corporate Complaint Manager

Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec’s revenues in 2023 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit Convatec Group.

Position Overview:

This position is responsible for establishing and maintaining an overall compliance framework for ConvaTec’s global Complaint process.

Ensures compliance to FDA 21 CFR Part 820, ISO 13485:2016, Medical Device Single Audit Program, and other applicable global Quality System Regulations.

Owns and oversees the global Complaint process including monitoring process performance and implementing continuous process improvement.

Strategic driver for a world class Complaint process.

Key Responsibilities:

General Expectations:

• Is a recognized subject matter in complaint obtained through advanced education and work experience.
• Shape the Complaint Process in the organization that enables the harmonization of the process execution.
• Collaborate across the organization to standardize and leverage best practices and metrics.
• Provides leadership, oversight, and strategic guidance for companywide issues related to Quality compliance.
• Liaise with Quality Leaders on assessing gaps and defining action plans related to Systemic Complaints, reviewing and supporting investigations as applicable.
• Anticipates, recognizes, communicates and manages quality issues within the organization and works with appropriate cross-functional areas to recommend actions to resolve the issues.

Complaint Process:

• Owns and oversees the global Complaint process from Intake to Closure of records, including monitoring process performance and implementing continuous process improvement.
• Oversees daily operational aspects of the Complaint Process. Ensures complaints are managed in a timely manner.
• Leads global continuous improvement workshops.
• Develops and provides general training to the global and site Complaint team and other applicable users as necessary.
• Lead process performance review meetings with the global Complaint team.
• Lead Corporate Complaint Review Board meetings.
• For TrackWise Complaint Module: Identify and assist with the implementation of updates to the TrackWise module; including participating in validation efforts.

General Quality Management System Support:

• Assists in the preparation and execution of site Management Review meetings.
• Participates as a site internal auditor, if competency requirements are satisfied.
• Maintains strong knowledge of medical device standards / regulations.

Health Authority/ Notified Body interactions:

• Participates as a Complaints subject matter expert during internal and external audits.

People Management:

• Supervises professional level employees and may also supervise some para-professional employees.
• Establish annual Goals and Objectives, sets standards and monitors staff performance; establishes the motivational climate and productivity goals for the group.
• Assists in the development of development and training plans.
• Coordinates changing priorities and organizes process improvement projects.
• Uses tools effectively to monitor progress and results.
• Ensures policies, practices and procedures are understood and followed by direct reports and stakeholders.
• Acts as the backup of Senior Director, Complaints & Post Market Surveillance.
• Coaches, reviews and delegates work to lower-level professionals.

Authority (if applicable):

• Review /Approve Quality Records such as Non-Conformances, CAPA, Complaint related records, Change Orders but not limited to.
• Acts as delegate of Senior Director, Complaints & Post Market Surveillance as required.

Skills & Experience:

• Comprehensive understanding in mechanism and key components in Quality Management System.
• Knowledge of regulations and standards in the quality management system for Medical Devices, e.g. ISO 13485, MDSAP.
• Willingness to adhere to all principles of confidentiality.
• Comfortable working in a highly regulated, fast-paced environment.
• Effective and proactive communication, particularly in a remote-working situation.
• Knowledge of and the ability to translate and apply the requirements of ISO 13485:2016, 21 CFR Part 820, and the Medical Device Single Audit Program (MDSAP); as well as 21 CFR Part 822 – Post market Surveillance, 21 CFR Part 803 Medical Device Reporting, EUMDR 2017/745 related Articles and Annexes.
• Ability to deal with difficult situations with tact and professionalism.
• Ability to communicate effectively in both oral and written communications, and work with employees at all levels of the organization.
• Demonstrate problem-solving and troubleshooting skills.
• Ability to work without close supervision and produce quality work.
• Proficient computer skills: MS Office (Outlook, PowerPoint, Word, and Excel), Microsoft Teams, and Adobe Acrobat Pro.
• Intermediate to Expert skill level utilizing TrackWise.
• Ability and agility to create and maintain dashboards to report performance of the process.

Qualifications/Education:

• Bachelor’s Degree in Science, Engineering, or related discipline.
• Minimum 5 years supporting a global Complaint process in the medical device or healthcare industry.

Principal Contacts & Purpose of Contact:

• Internal – Vigilance Team, Complaint Intake team, Global Site Complaint Engineers, Information Management, and Executive Management, Global quality management, Site Quality Leads, R&D, Regulatory Affairs, Clinical Affairs, Quality Engineering, and all other functions as required by the role.
• External – External Auditors and Inspectors, Regulatory Agencies, and Notified Bodies.

Travel Requirements:

Position may involve travel up to 10% of the time, this may include overseas travel. Most trips will include overnight travel.

Languages:

• Speaking: Yes English*
• Writing/Reading: Yes English*

*additional languages nice to have

Working Conditions:

This is a remote position but office presence will be required or allowed for certain meetings, events, or to meet certain business needs.

Special Factors:

Maintain communication with contacts across several time zones worldwide.

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Additionally, this job description reflects management’s assignment of essential functions. It does not prescribe or restrict the tasks that may be assigned.

Our products make a big difference every day. So will your contribution. The work you do will mean more, because it’ll make things better for your team, our business or our customers’ lives. It’ll inspire you to deliver to your very best. And we’ll be right behind you when you do.

This is a challenge more worthwhile.

This is work that’ll move you.

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