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 http://www.convatecgroup.com
Every day, our products improve the lives of millions of people around the world. We’re hugely proud of this, which is why we’re transforming our business to reach millions more. Join us on our journey to #ForeverCaring as a Corporate Complaint Manager, and you’ll drive progress that really means something.
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 enable the harmonization of the process execution.
- Collaborate across the organization to standardize and leverage best practices and metrics across the organization.
- Provides leadership, oversight, and strategic guidance for companywide issues related to Quality compliance.
- Liaise with Quality Leaders on assessing gaps and defining actions 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 manages within timely manner. Ensure complaints requiring escalation are managed timelly.
- Leads global continuous improvement workshops.
- Develops and provides general training to the global and site Complaint team and other applicable users as necessary. Will also facilitate training when changes are made to the process, procedure, or TrackWise (TW) system.
- 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 e.g. user acceptance testing.
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; provides performance feedback; writes and conducts appraisals for employees.
- Assists in 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 back up 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 too
- 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 trouble shooting 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
- 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.
#LI-KM1
#LI-remote
Beware of scams online or from individuals claiming to represent Convatec
A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.
If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you’re unsure, please contact us at careers@Convatec.com.
Equal opportunities
Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.
Notice to Agency and Search Firm Representatives
Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
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