Sr. Quality Systems Specialist II- Complaint Management
Job Description Summary•
Be part of something bigger!
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues..
Key responsibilities will include:
Accountable for setting own work direction and completing work tasks.
Under the direction of the Complaint Management Center Lead, the Sr. Quality Systems Specialist II - Complaint Management handles activities and procedures associated with IDS product complaints. This person will be accountable for setting their own work direction, and completing their work tasks. They will supervise the processing of customer complaints, including maintenance of complaint files, responses to customers, and Quality reports. They will be responsible for a variety of mechanical and functional product evaluations related to the investigation of customer complaints. As well as supporting Market Segment Teams. This person must be able to lead the end to end process of customer complaints, including utilization of the database systems used to process complaints, and will be responsible for processing of customer complaints specifically Medical Device Reports (MDR’s), and complaint reports.
Provide mentorship and education regarding customer complaint processing, MDR’s, complaint report ability, and regulatory compliance.
Fills out decision trees when needed, after appropriate complaint investigation and files MedWatch reports after Leader reviews and approves.
Develop, implement and follow procedures to ensure timely and accurate receipt, logging, analysis and response to customer complaints. Reviews all customer complaints for validity and assures complaints are processed in compliance with policies and procedures.
Provide mentorship, review and generates MDR reports utilizing BD procedures and FDA regulations.
Contribute to the business-wide quality strategy and quality objectives
Maintain systems to supervise and facilitate the timely investigations and close out of open complaints. Ensure complaints are investigated and completed in a timely manner.
Supervise and communicate significant complaint trends, adverse events and other pertinent reports
Provides and analyzes organizational quality metrics as required to assess the efficiency of quality system improvements. Provide internal awareness of noted trends and complaint issues via periodic and ad hoc reports as required by the business unit/platform team.
Interact with Health Care Workers, Consumers and other professionals regarding their Product Quality concerns on an as needed basis.
Ensure the customer complaint investigation, procedures, and activities follow applicable FDA and ISO requirements for complaint handling and adverse event reporting. .
Exhibit flexibility and resourcefulness by leading assignments in accordance with project priorities and by altering course of action when and where vital
Ensure ethical responsibility to maintain privacy and confidentiality of patient records and private information.
Represents IDS on cross-business teams related to Quality Systems.
Partners with other quality professionals to address recurring issues identified throughout the organization.
Provides Education: Provides ongoing education and training of new and current staff on product usage, common complaint scenarios, appropriate data capture, regulatory requirements and initial and ongoing assessment.
Education and competences required:
Strong analytical, deductive reasoning and listening skills
High level of problem identification, analysis, and formulation of conceptual / technical and business solutions
Ability to influence without authority and deal optimally with ambiguity
Effectively communicate precisely and accurately to all levels of the organization
Strong product knowledge of clinical application usage and/or manufacturing process
Strong business, technical and digital literacy
Strong project management skills
Solid understanding of regulatory standards applicable to design of medical devices, including FDA QSR 21 CFR 820, ISO 13845, ISO 14971 and IEC 60601 and collateral standards highly desired
Medical device standards and FDA guidance relevant to medical devices.
Must have knowledge of product failure modes. Demonstrate competence in mechanical and functional risk assessment.
Experience in health care setting where BD or similar products are used, e.g. clinical labs, hospitals, ICU’s, health care delivery settings.
Minimum of one (1) years’ experience in health care setting where BD or similar products are used, e.g. clinical labs, hospitals, ICU’s, health care delivery settings.
One to three years of related experience in a manufacturing environment, preferably in the Medical Device and/or Manufacturing Environment
Minimum of BS Degree in Medical Technology, Biomedical Engineering or related healthcare / Engineering subject area.
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We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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 empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
To learn more about BD visit https://jobs.bd.com/
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.
Primary Work LocationUSA MD - Sparks - 7 Loveton Circle
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Approbationdu Présiden et Chef de la direction
«Nous sommes une entreprise qui vise des résultats concrets et où nos associés s’emploient chaque jour à améliorer les soins de santé. De nombreuses initiatives sont en cours pour faire de BD un leader mondial des technologies médicales.»
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