Quality Compliance Specialist at Bioventus in Memphis, Tennessee

Job Description:

Description

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.

Who is Bioventus?

We are the market leader in developing clinically proven and cost-effective orthobiologic solutions for surgical and non-surgical bone healing and osteoarthritis, with products recognized for their safety, innovation and effectiveness.

$350+ million in annual revenue

700 employees worldwide

Helping 440,000+ people every year

The Bioventus team always puts patients at the forefront, and their needs are the priority in the choices we make and actions we take.

Quality Compliance Specialist

Full time, Office Based, Memphis TN

The Quality Compliance Specialist is responsible for performing investigations into adverse events and product complaints in accordance to internal and external policies and procedures. The position supports the product lifecycle of medical devices by evaluating the performance, safety, and effectiveness of medical devices after commercialization.

Ideal candidates have strong interpersonal skills and determination to provide the best possible experience to our customers and coworkers. They strive for excellent performance, driven by the willingness to both teach and learn. They are good team players, dynamic, optimistic, accurate, well-organized, and ambitious about developing as a professional.

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.


• Evaluates complaint information and determines appropriate regulatory reporting requirements. Prepare and submit reports to FDA and other regulatory agencies within required timeframes.


• Resolves issues or provides clinical/technical explanation to complainant regarding reported event.


• Evaluates information obtained during complaint investigation to determine if device failed to meet specifications and if corrective action is required.


• 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 from a recognised institution; in biology, health sciences, engineering, nursing or other related discipline with at least 1 year of experience in complaint handling and adverse event reporting.


• Knowledge of quality system regulations (FDA QSR, ISO 13485) is preferred.


• Must possess good verbal and written communication skills with an investigative mindset and critical analysis skills.

What you'll receive

• The satisfaction of driving real change in the industry and people's lives


• A diverse global community of people who are driven by a shared purpose to help patients


• A business that acts with integrity in all interactions with co-workers, leaders and customers


• We value others and build success by appreciating differences in thought, opinion, background, skills and perspectives


• An environment of continuous learning and development


• Flat organizational structures which elevate employees' level of responsibility


• Meaningful opportunities for professional development and mentoring


• Competitive compensation package, including bonus


• Exciting benefits package, including three weeks' vacation; medical, dental and vision benefits; life insurance; and a 401(k) plan

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 ofdiversity, andtake 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, ability, gender, gender expression, gender identity, nationality, race, religion or sexual orientation.All individuals, regardless of personal characteristics, are encouraged to apply.