Quality Complaint Specialist (Finance)
Are you ready to work for a more active world?
At Bioventus, our business depends on developing our people. We invest in you and challenge you to be the best. We value our colleagues for their different perspectives and individual contributions, and our leaders listen. Our success rests on working together to achieve shared goals and rewards. Join a diverse team of global colleagues driven to help patients resume and enjoy active lives.
The Quality Complaint Specialist is responsible for performing thorough investigations of product complaints in accordance with Company policy and external regulatory requirements, as applicable. The position also assists with Quality Management System reviews and quality audits.
What you'll be doing
- Facilitates the compliant handling process by receiving, reviewing and entering product complaint information into database.
- Coordinates and prioritizes complaint investigations to ensure that complaints are processed in a timely manner.
- Responds to client, regulators or others as necessary within time restrictions.
- Organizes and facilitates meetings to discuss complaints, prepares meeting minutes, and follows up on action items.
- Evaluates information obtained during complaint investigation to determine if device failed to meet specifications. Resolves issues or provides clinical/technical explanation to complainant regarding reported event.
- Ensures proper disposition of returned products for complaint analysis. Evaluates complaint information and determines appropriate regulatory reporting requirements.
- Prepares and submits reports to FDA and other regulatory agencies within required timeframes.
- Prepares and analyzes complaint reports on a bi-weekly, monthly and annual basis. Participates in Post-Market Surveillance (PMS) activities.
- Holds oneself and others accountable to conduct business in a manner compliant with Bioventus' Code of Compliance and Ethics, policies and procedures and internal controls applicable to their role.
- Other duties as assigned
What you'll bring to the table
- Bachelor degree with a minimum of 1-year experience, or Associate degree plus 3 years' experience in Regulatory, Quality Control, Healthcare or equivalent experience.
- Knowledge of FDA regulations 21CFR Part 803 and ISO13485. Knowledge of medical device products and manufacturing processes a plus. Knowledge of FDA, Canadian, European regulations and quality system regulations, helpful.
- Ability to analyze data, looking for trends & finding ways to summarize and report findings. Must possess excellent verbal and written communication skills.
- Ability to prioritize work load to ensure accurate work within strict time frames in regards to investigating, answering & reporting complaints. Ability to multi-task and independently manage workload.
- Requires computer literacy and ability to use Microsoft Office software (Word, excel, PowerPoint, Outlook). Experience working with Pilgrim and SAP is preferred
Are you the top talent we are looking for?
Apply now! Hit the "Apply" button to send us your resume and cover letter.
Bioventus is committed to fostering an inclusive and diverse community of employees with a strong sense of belonging. We believe we are bettered by all forms of diversity and take pride in working with top talent from every walk of life. In the spirit of inclusivity, qualified applicants will be considered without regard to age, ethnicity, disability, gender, veteran status, gender expression, gender identity, nationality, race, religion or sexual orientation. All individuals, regardless of personal characteristics, are encouraged to apply.
