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Job Description Summary

The Manager, Complaint Management role is responsible for investigational activities relating to infusion pumps and monitoring devices. This role manages a team of engineers and technicians and is responsible for the development, implementation, and maintenance of processes associated with complaint investigations requiring failure analysis of returned infusion systems and component parts from servicing operations. This individual will be responsible for the integrity of the investigations and ensure investigation conclusions are clear, supported, robust, and compliant. This individual will establish best practices in investigation failure analysis processes for large volumes of complaints and associated root cause determination, including inspection, test protocols and methodologies. Additionally, this individual should have strong analytical skills and effective communication across all levels of the company and demonstrate strong teamwork and collaboration across several function areas to understand product issues in the field and drive continuous product improvements.

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.

Duties & Responsibilities

• Develops, implements, and maintains complaint investigation failure analysis processes including writing requirements, process documentation, inspection and test protocols for systems, modules and component parts.

• Design, purchase and release of investigation test fixtures for failure analysis lab. This may also include leading and performing IQ/OQ/PQ test fixture verification activities that business process deems necessary.

• Ability to solve complex problems by developing investigation test methodologies, processes & training materials.

• Serve as a domain expert for failure analyses that includes both internal functional support and external customer support with respect to analysis findings and associated improvements initiatives.

• Provide failure analysis & quality engineering expertise & consultation to significant / complex projects.

• Ensure accurate completion of complaint failure investigations and communicate with management and team members as required to ensure appropriate actions are taken to maintain timeliness goals.

• Ensure all complaint investigations have been adequately risk-assessed and initiate and escalate new failure modes for risk assessment, as required.

• Own and/or lead investigations & root cause analysis efforts for Corrective and Preventive Actions (CAPAs) when necessary. Support CAPA investigations by R&D and Operations where field return analyses may assist in those CAPA investigations. Support, and provide feedback to, monthly complaint trend reviews and resulting CAPA triggers.

• Develop, compile and present complaint investigation and failure analysis summary metrics to Senior and Executive Management, as necessary.

• Communicates investigation findings to appropriate personnel and raises to Design Quality Engineering, R&D, Operations and others on critical or emergent field issues, as necessary

• Contribute to product safety, product quality, and customer satisfaction related decisions (both data-based and risk-assessment-based decisions).

• Ensure complaint investigation and failure analysis documentation and records are complete and in compliance with regulatory requirements.

• Participate and support internal, external audits and inspections as needed.

• Performs other related duties and activities as required: project management, resource assessments, presentation creation and strategic planning

• Implements processes for handling a large volume of complaints incoming through customer reported events and global servicing activities including, depot and field service records.

• Identifies and implements efficiency and compliance improvements to the failure analysis process.

• Participates in external regulatory inspections. Ensures that pre and post-inspection activities are completed including record review, training, logistics, etc. Prepares responses to audit nonconformities for review by senior management with respect to complaint investigations.

• Provide guidance and mentoring to failure analysis team to ensure investigation best-practices are implemented and used during complaint investigations of Pyxis Dispensing Systems and components.

Qualifications (Education & Experience)

• BS/BA in engineering field or equivalent experience with infusion pump investigations

• Experience leading a Failure Investigation team

• Minimum of 10 years of experience in failure analysis, manufacturing operations, servicing, and/or R&D activities leading investigation teams or designing inspections and tests for complex electro-mechanical equipment.

• Demonstrated history of effective root cause determination in complex electro-mechanical, software-driven medical devices.

• Must possess ability to establish new failure investigation processes, test protocols, and procedures and to build a team performing these activities.

• Specific knowledge of Pyxis Dispensing Units is preferred

• Professional certification is a plus; e.g. Six Sigma Green Belt, etc.

Knowledge, Skills & Abilities

• Effective oral and written communication skills targeted at all levels within the company.

• Experience in supervision; experience in managing a product/component failure analysis lab is a plus.

• Strong interpersonal skills including relationship building, conflict resolution, and verbal and written communication are essential in this collaborative work environment.

• Demonstrated ability to manage, develop and mentor exempt and non-exempt level personnel both inside and outside the department reporting structure.

• Demonstrated knowledge of implementing test methods & associated validation strategy & documentation.

• Project management utilizing analytical, technical, and problem-solving skills.

• Able to perform multiple complex tasks & prioritize workloads & activities for large volumes of complaints.

• Strong organizational skills & proven ability to meet deadlines in an environment of competing priorities.

• Excellent computer skills (Including but not limited to: Microsoft Office, Minitab, SAP, TrackWise)

• Extensive knowledge of FDA Quality Systems Regulations 21 CFR Part 820, Medical Device Reporting 21 CFR 803, Report of Corrections and Removals 21 CFR 806, ISO 13485 Quality Management Systems Medical Devices, ISO 14971 Risk Management and International Regulations for Medical Devices, such as EU Medical Device Regulation (MDR), Canada SOR/98-282 Medical Device Regulations.

• Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously.

• Demonstrated ability to successfully interact with regulatory authorities during inspections & audit related to complex technical documentation; defending failure investigation activities as failure investigation SME during inspections is a plus.

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/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.

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Primary Work Location

USA CA - San Diego TC Bldg C&D

Additional Locations

Work Shift

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 (https://jobs.bd.com/benefits) .

Salary 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 offered to a successful candidate is based on experience, education, skills, and actual work location. Salary ranges may vary for Field-based and Remote roles.

Salary Range Information

$124,100.00 - $204,800.00 USD Annual

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.