- Perform and supervise the complaint handling process by evaluating potential product issues and allegations to determine if the complaint process is applicable, completing complaint investigations and failure analysis, and evaluating complaints for regulatory reportability and creating and submitting reports that comply with applicable regulations.
- Performs complaint record administration in the electronic system and reviews and approves complaint records.
- Performs and supervises the post market surveillance process by evaluating product trends and product changes and maintaining risk management documentation, monitoring the process using metrics, taking action to improve efficiency and ensure compliance, and reporting results to management, maintaining a thorough knowledge of new and existing regulatory requirements and updating assigned processes, and participating in internal and external audits of assigned processes that assess compliance.
- Provides supervision of the people performing the complaint handling process, overseeing day-to-day activities, assigning tasks, and providing oversight to ensure that tasks are executed in accordance with the applicable requirements.
- Provides process ownership, subject matter expertise, and training on the process.
- Associates degree is required and a minimum of 2 years of related job experience.
- Good communication skills and demonstrated command of the English language (oral and written)
- Knowledge of medical device quality and safety requirement and knowledge of quality and engineering standards; Familiar with ISO 13485.
- Excellent organizational skills and proficiency in Microsoft Office applications.
- Demonstrated leadership skills, as well as success working independently and in a team environment.
- Paid time off and paid volunteer time
- Medical, Dental, Vision and Flexible Spending Account
- Health Savings Account with Company Funded Contributions
- 401k Retirement Plan with Company Match
- Parental Leave and Adoption Services
- Health and Wellness Programs and Events
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Complaint Supervisor - Portsmouth, United States - Laborie
Description
We believe that great healthcare is an essential safeguard of human dignity.
At Laborie, we know the work we do matters – it's what fuels our motivation and contributes to our success. If you're ready to make a positive impact in the lives of patients across the globe, we'd like to meet you.
We support and empower our employees to grow their careers in an environment that encourages a sense of belonging and a connection to doing good. We're not afraid to roll up our sleeves to make our goals a reality and work together to solve for our customers. We reward and recognize our employees based on our values of Aspire to Greatness, Respect All, Own It, Working Together, Persist with Passion.
Who We're Looking For:
As a key member of the Quality team, the Complaint Supervisor develops, establishes, and maintains assigned quality management system processes to ensure compliance with applicable regulations and standards. The main purpose of this job is to execute the Complaint Handling process and supervise the people performing the Complaint Handling process.
About the Role:
Minimum Qualifications:
Why Laborie:
Laborie provides equal employment opportunities and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Laborie is committed to providing access and reasonable accommodation in our services, activities, education, and employment for individuals with disabilities.
