Job Description Summary

As directed by the Quality Manager, the Quality System Specialist III is accountable for support of the continued development, improvement and implementation of the Quality Systems. This position actively participates in quality guidance, product resolution decisions and statistical problem solving techniques to New Product Development and project teams for process improvement and continuous improvement activities.

Job Description

We are the makers of possible 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

Responsibilities:

• Consistent application of Quality system standards to assigned Quality system area.

• Develops solutions to routine assigned activities of moderate scope & complexity.

• Follows applicable Company / Unit procedures and may make updates to procedures and policies

• Works within and across functions for assigned Quality systems                              

• Working Knowledge of Quality Systems Regulatory requirements and  application to Company /Unit requirements

• Accountable for setting own work direction and completing work tasks.  

• Able to manage the end to end process of customer complaints including review and maintenance of complaint files and responses sent to customer.

• Investigate customer complaints for assigned products and processes, including the identification of root causes and contributing factors wherever possible.

• Recommend corrective and/or preventative action(s) related to customer complaint issues.

• Identify and monitor patterns and trends in complaint issues related to assigned product groups.

• Provide a documented report that clearly outlines the investigation process, investigation findings, frequency of related events, corrective actions and recommendations.

• Develop test protocols and reports where required.

• Escalate high priority issues as well as identified business risks to the appropriate management level.

• Escalation of complaints and assist in complaint investigations as required.

• Review all customer complaints, investigations and communications for validity and assures compliance with policies and procedures.

• Development of Complaint Closure Letters as required.

• Work with Regional Complaint Centers to resolve and address complaint handling issues. Utilization of database systems used to process complaints, create and measure Quality metrics and electronic MDR reports.

• Development and input to the MDR guidelines to identify failures leading to malfunction reporting requirements.

• Responsible for reviewing customer complaints received for Medical Device Reports (MDRs), FDA and ISO requirements.

• Provide internal guidance and education regarding customer complaint processing, MDRs, and regulatory compliance.

• Files MedWatch reports after Leader reviews and approves if applicable.

• Perform other duties as assigned.

Additional Responsibilities:

• Contributes to the completion of specific programs and projects. 

• Develop, implement and follow procedures to ensure timely and accurate receipt documentation, analysis, and response to customer complaints.

• Contribute to the business-wide Quality strategy and objectives. 

• Ensure the customer complaint investigation, procedures, and activities comply with applicable FDA and ISO requirements for complaint handling and adverse event reporting

• Exhibit flexibility and adaptability by managing assignments in accordance with project priorities and by altering course of action when and where necessary.

• Represent BD MDS on cross-business teams related to Quality Systems.

Required Qualifications:

• Requires a minimum of a Degree in Nursing and/or other Clinical education or a degree in Biomedical engineering

• Minimum of 3 years relevant experience in a healthcare setting

• Consistent application of Quality system standards to assigned Quality system area.

• Working Knowledge of Quality Systems Regulatory requirements and  application to Company /Unit requirements

• Understanding of complaint handling, experience with TrackWise preferred. Strong knowledge of Microsoft excel, word and PowerPoint.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.  

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.  

To learn more about BD visit https://bd.com/careers

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.

#LI-OPS

Required Skills

Optional Skills

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Primary Work Location

USA IL - Vernon Hills

Additional Locations

Work Shift

NA (United States of America)

At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.

Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.

Salary Range Information

$92,700.00 - $152,900.00 USD Annual