Convatec · 3 hours ago
Corporate Complaint Manager
US
Full-time
Remote
Senior Level
5+ years exp
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Responsibilities
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.
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.
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.
Participates as a Complaints subject matter expert during internal and external audits.
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.
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.
Qualification
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Required
Bachelor’s Degree in Science, Engineering, or related discipline.
Minimum 5 years supporting a global Complaint process in the medical device or healthcare industry.
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.
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.
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 within timely manner. Ensure complaints requiring escalation are managed timely.
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.
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.
Participates as a Complaints subject matter expert during internal and external audits.
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.
Preferred
Additional languages nice to have
Company
Convatec
ConvaTec specializes in the development, manufacture, distribution of single-use devices to hospitals and healthcare sectors. It is a sub-organization of The Amcare™ Group.
5001-10000 employees
H1B Sponsorship
Convatec has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2021 (1)
2020 (6)
Funding
Current Stage
Public CompanyTotal Funding
$1.26BKey Investors
Novo Holdings
2017-03-29Post Ipo Equity· $1.26B
2016-10-27IPO
Leadership Team
Karim Bitar
Chief Executive Officer
Divakar Ramakrishnan
Chief Technology Officer
Recent News
2024-12-12
MarketScreener
2024-11-12
Company data provided by crunchbase
