Complaint Management Business Unit Manager
hace 1 semana
At **Johnson & Johnson Medical Devices Companies **, we are using our breadth, scale, and experience to reimagine the way healthcare is delivered and to help people live longer, healthier lives.
In a radically changing environment, we are making connections across science and technology to combine our own expertise in surgery, orthopedics, and interventional solutions with the big ideas of others to design and deliver doctor and patient-centric products and solutions.
**We are in this for life **.
We are changing the trajectory of human health, **YOU CAN TOO.**
We are searching for the best talent for a **COMPLAINT MANAGEMENT BUSINESS UNIT MANAGER** to be in **Ciudad Juarez, Mexico.**
**Purpose**:
Under minimum supervision, the Complaints Handling Unit Manager will be responsible for supervising the Failure Analysis Lab and the Complaints Analysts. This individual will also be responsible for maintaining the quality processes associated with product complaint handling, procedures, and controls to ensure that all complaints are processed in accordance with established company procedures and worldwide regulations and standards.This position will have responsibilities across Cardiovascular and Specialty Solution (CSS) Companies Johnson and Johnson Family of Companies) including a span of variousnew and reprocessed SpecialtySurgical Devicesfor use in Neurovascular,ENT, Electrophysiology, Surgical and Non-Surgical Aesthetics
Requirements:
Evaluates all information from a clinical and technical perspective to ensure appropriate Analysis, investigation, Root Cause, and Quality Engineering review is documented prior to complain closure.
Guarantees all required regulatory reports are completed and reported according to regulatory requirements.
Establish reports for the prompt review of new complaints, regulatory reporting decisions, and follow-up
Possess a thorough understanding of the complaint database.
Ensure the development, preparation, analysis, and presentation of complaint trend reports.
Set up compliant meetings and effectively communicate with worldwide complaint groups, as well as other internal departments such as Marketing, R&D, Customer Service, and Technical Services.
Understands principles, theories concepts and techniques related to customer complaints.
Investigate and develop solutions to procedure and process related issues. Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
Initiate and investigate Corrective and Preventive Actions (CAPA) as appropriate. Assist in complaint analysis. Assist Regulatory Affairs in developing submissions for new devices as necessary.
Work is expected to result in the development of new or improved techniques or procedures.
Develop and establish effective quality control and associated risk management plans as needed
Responsiblefor WW Complaints entry, management, and closure.
Responsible for assuring compliance with J&J timeliness metrics.
Develops, mentors, plans and coordinates workload for Complaints Quality Engineers and Complaints Analysts.
Responsible for conducting Performance Reviews and set Goals & Objectives for Complaints Quality Engineers and Complaints Analysts.
Plans, develops, coordinates, and directs projects with varying levels of complexity.
Ensure compliance with the company’s Quality System policies and procedures and applicable external requirements and standards, includingFDA, ISO 13485, andother worldwide regulatory agencies, Johnson & Johnson Environmental, Health & Safety Practices, and other applicable standards as pertains to medical devices.
Responsible for ensuring the Complaints Handling Unit documents all required information for complaint files is obtained and properly documented to make sound regulatory reporting decisions
**Qualifications**:
Qualifications:
- BS in computer science, engineering, physical, biological, or natural sciences is required, along with a minimum of 7 years of quality, manufacturing, or regulatory experience in a medical device or other regulated industry
- Minimum of 3 years of previous supervisory experience.
- supervisory and leadership skills
- Regulatory compliance knowledge
- Excellent interpersonal skills
- Advanced Quality Assurance and Quality Systems knowledge
- Problem-solving, Statistical Skills
- Must possess the basic understanding of engineering fundamentals
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