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Jobs · Quality Assurance · Arizona

Quality Engineer I, Post Market Surveillance (PMS) - Becton Dickinson

BD · Tempe, AZ · 3 wk ago
On-siteQuality AssuranceFull-time

About the role

BD is one of the largest global medical technology companies in the world, advancing the world of health through transformative solutions. This role involves working with a team to ensure compliance with global regulations and generating periodic Post-Market Surveillance (PMS) reports.

Responsibilities

  • Work with a team to meet requirements in generating periodic PMS-related reports.
  • Participate in projects to align with BD 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 applicable reports.
  • Coordinate and provide oversight in the analysis of PMS data.
  • Identify and escalate instances when products are not achieving intended performance based on 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 bodies.
  • Work cross-functionally with Quality, Regulatory, Clinical Affairs, 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 and JDE.
  • Perform other related duties and responsibilities as assigned.
  • Travel up to 5% of the time.

Requirements

  • Apply project management tools to ensure reports are submitted based on commitment timelines.
  • Ability to make and present risk-based decisions.
  • Strong interpersonal skills.
  • Problem-solving ability.
  • Ability to create, review, and coordinate reports based on established guidelines and regulatory requirements.
  • Oral and written presentation skills.
  • Ability to provide analysis within strict timeline requirements and assume accountability toward delivering on agreed-upon commitments.

Qualifications

  • Minimum of a bachelor's degree in Engineering, a technical field, or equivalent.
  • Proficient in Windows OS and Microsoft Office Suite.
  • Proficient in Excel for data manipulation.

Preferred Skills

  • Medical device experience working with Class I, II, and III devices.
  • Experience in technical writing and project management.
  • Ability to develop and maintain dashboards using BI tools.

Physical Demands

  • Regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle, or feel objects, tools, controls, and office equipment.
  • Frequently required to verbally communicate with other associates.
  • Occasionally required to reach with hands and arms and stoop, kneel, or crouch.
  • Work in an open cubicle environment.
  • Work in a team-oriented, fast-paced environment.
  • Occasionally work in a preclinical setting like an animal lab, cadaver lab, or attend clinical case observations.

Schedule

For most roles, a minimum of 4 days of in-office presence per week is required to maintain our culture of excellence and ensure smooth operations.

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.

Location

USA AZ - Tempe Headquarters

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