US National – Telecommute
Quality and Regulatory Complaint Handling Process Owner
United States of America – Home Based
In this role, you have the opportunity to
Implement, control and improve Monitoring & Analytics and Therapeutic Care (MA&TC) Post Market Surveillance Complaint Handling processes. This includes consideration of external regulations and standards along with internal policies, procedures, work instructions, software tools and product training for a process that can be easily subjected to audit and effectively links with other processes.
You are responsible for:
Implementing ideas and influencing needed change to support regulatory requirements along with operating an effective and efficient process.
Working with multiple segments of the company to identify operations adjustments in order to achieve strategic goals.
Communicating process changes to process users.
Overseeing interfaces with other processes.
Analyzing performance data, setting quality objectives and tracking progress against targets.
Identifying risks and improvement opportunities with current process.
Leading and implementing continuous improvement activities.
Providing subject matter expertise and technical support to the MA&TC complaint handling function. Resolving problems and preventing their recurrence.
Administering applicable complaint handling procedures and work instructions.
Maintaining professional communications with internal and external customers.
Supporting and participating in internal and external audit-related activities.
Ensuring training compliance by completing mandatory training by established due dates.
Adhering to company and departmental policies and procedures to ensure regulatory compliance.
Contributing to the completion of projects and tasks as assigned.
You are a part of:
As a result of Philips renewed dedication to Quality, it has recently restructured its organization to ensure you and your department have clear collaboration with Philips Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world.
To succeed in this role, you should have the following skills and experience
5+ years experience in a medical device or other regulated environment including in-depth process knowledge of post-market surveillance complaint handling and associated regulatory reporting is required.
Effective change management across varying levels of the organization.
Excellent written and oral communication skills.
Self-driven with the ability to motivate, influence, negotiate and coordinate in order to effect change.
Strong business acumen to understand upstream processes that deliver inputs to the complaint handling process as well as downstream customers that receive complaint handling outputs for further processing.
Good analytical skills and process improvement capabilities with the ability to resolve complex issues in creative and effective ways.
Education & Training , Operations