Job Description Summary

The Quality Engineer ll supports coordination and management of Post Market Surveillance reports through the collection, analyses, review, trending, and reporting on product safety data to proactively identify potential adverse safety risks or performance trends. The incumbent will collaborate with cross-functional team members to ensure compliance to the applicable regulations, standards, and company policies/procedures. This position plays an integral role in maintaining compliance with global regulations.

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. 

Essential / Key Job Responsibilities (including supervisory and/or fiscal):

• Work with a team to meet the requirements in generating periodic PMS related reports

• Identify development and training opportunities for PMS team along with Manager

• Participate in projects to align with BDX Quality, MDD/MDR strategies and regulatory submissions

• Identify gaps and maintain PMS processes in compliance with global regulations

• Participate in PMS planning and reporting

• Extract and generate PMS and operational performance data necessary for generating

• applicable reports.

• Coordinate and provide oversight in the analysis of PMS data

• Identify and escalate instances when products are not achieving the intended performance based upon anticipated levels of frequency and/or severity

• Identify and evaluate new failure modes when encountered

• Maintain procedures, as necessary

• Support responding to requests for additional information from competent authorities,

• registries and notified body

• Working cross-functionally with Quality, Regulatory, Clinical Affair and Operations departments to fulfill ad-hoc data requests and deliver detailed analysis of PMS data

• Develop and maintain knowledge of support systems including Master Control, JDE

• Performs other related duties and responsibilities as assigned

Required Qualifications:

• Medical device experience working with Class l, ll, and lll devices

• Apply project management tools to ensure reports are submitted based on the commitment timelines

• Working knowledge of project management, presentation methods, and risk assessment techniques

• Ability to make and present risk-based decisions

• Strong interpersonal skills

• Ability to create and provide training

• Problem solving ability

• Ability to create, review and coordinate reports based on established guidelines and regulatory requirements

• Oral and written presentation skills

• Ability to Lead cross functional teams

• Ability to provide analysis within strict timeline requirements and assuming accountability toward delivering on agreed upon commitments

• Understanding of regulatory requirements including ISO 13485 

Education and/or Experience:

• Requires a minimum of a bachelor’s degree, Engineering Degree, or degree in a technical field

• Minimum of 3 years relevant experience or a combination of equivalent education and relevant experience. 

• Experience in technical writing and project management

• Proficient in Windows OS, Microsoft Office Suite particularly PowerPoint

• Proficient in Excel in manipulation of data

Preferred Knowledge/Experience:

• Ability to develop & maintain dashboards using BI tools

Physical Demands:

While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally communicate with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch. 

Work Environment:

While performing the duties of this job, the employee may be in an open cubicle environment.  Candidate must be able to work in a team-oriented, fast-paced environment. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.

This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.

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. 

PDN

Primary Work Location

USA AZ - Tempe Headquarters

Additional Locations

Work Shift