QA Manager, Complaint Handling

Job Description Summary

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.

The QA Manager, Customer Complaint Handling is responsible for assuring quality standards and regulatory compliance are consistent with Corporate and Division Policies, Government Regulations, International Standards, supporting customer complaints and their timely responses (risk assessment and or field corrective action). Applies project management skills to lead cross-functional and interdepartmental investigations and ensures production and quality issues are closed with effective solutions. Possess in-depth knowledge of current Manufacturing and Quality Control processes.

Functional Responsibilities:

• Execution of the implementation plan for ISO standards (i.e: ISO 9001 and ISO 13485) requirements.
• Lead the site complaint handling process in conjunction with the San Jose site PMS Quality team and cross functional representatives.
• Effective use root cause analysis, application of technical principles, quality tools and quality systems.
• Presentation of quality metric results (i.e.: customer complaint trending) to functional stakeholders and senior leaders.
• Ensures data collection is gathered per management requirements and is involved in the analysis of this data.
• Follow up to ensure results are translated into updates to Risk Management File documentation.
• Oversees the site customer complaint process and provides guidance to complaint owners in Trackwise to ensure that activities are performed in accordance with Quality System and Regulatory requirements to reduce causes of customer complaints, non-conformances, and deficiencies within other quality system elements.
• Drive quality improvements through complaints, nonconformances, CAPA, and engineering data analysis working in a cross-functional matrix environment.
• Mentor and develop department personnel, including succession planning and contingency management. Provide advice and mentor junior associates.
• Focuses on employee engagement activities including development and retention, while also responsible for carrying out hiring, job assignments, termination recommendations, transfers, promotions, salary actions, and performance reviews on time.
• Acts as advisor and coach to subordinates to meet schedules and resolve technical problems. Develops and administers work schedules and provides management with updates on work assignment, quality metrics, and or quality issues.
• Performs other tasks assigned by management as required.

Education and Experience:

• Minimum BS in life science or engineering discipline.
• Minimum 5 years of management role within ISO 13485 complaints in medical, pharmaceutical or biotechnology industry.
• Customer complaints handling processes for clinical products.
• Working knowledge of the FDA medical device quality system regulations and international quality system standards/regulations (e.g. ISO 9001, ISO 13485).
• Able to use judgement to influence within and across functions to drive impact on the business/function.
• Must have knowledge/specialization in one or more of the following areas:
  • Statistical process control methods and application
  • Failure analysis investigation
  • Process mapping and value stream analysis
  • Basic quality tools: Pareto, box plots, histograms, scatter diagrams, etc.
  • Risk Management
  • Nonconforming Material/Processes

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.

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. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. And through the organization's investment in BD University, you will continually level up your tech skills and expertise.

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.

PDN

Primary Work Location

USA CA - San Diego (BDB)

Additional Locations

USA CA - Brea, USA CA - El Cajon, USA CA - Irvine Neomend, USA CA - San Diego (IDS), USA CA - San Diego Bldg A&B, USA CA - San Diego - Road to the Cure, USA CA - San Diego TC Bldg C&D, USA CA - San Jose, USA CA Temecula, USA IL - Carol Stream

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.

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

$121,100.00 - $199,800.00