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Quality Engineer I, Post Market Surveillance

4 weeks ago

Enniscorthy, Loch Garman, Ireland BD Full time

Job Description Summary

We are looking for a Quality Engineer I, for our facility in BD Enniscorthy. You will support 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.

As the successful candidate, you will collaborate with cross-functional team members to ensure compliance with the applicable regulations, standards, and company policies/procedures.

This position plays an integral role in maintaining compliance with global regulations. You will also work closely with the different functions onsite and between sites.

Main Responsibilities Will Include

  1. Work with a team to meet the requirements in generating periodic PMS related reports.
  2. Participate in projects to align with BD Quality, MDD/MDR strategies and regulatory submissions.
  3. Identify gaps and maintain PMS processes in compliance with global regulations.
  4. Participate in PMS planning and reporting.
  5. Extract and generate PMS and operational performance data vital for generating applicable reports.
  6. Coordinate and provide oversight in the analysis of PMS data.
  7. Identify and escalate instances when products are not achieving the intended performance based upon anticipated levels of frequency and/or severity.
  8. Identify and evaluate new failure modes when encountered.
  9. Maintain procedures, as necessary.
  10. Support responding to requests for additional information from competent authorities, registries and notified bodies.
  11. Work cross-functionally with Quality, Regulatory, Clinical Affairs, and Operations departments to fulfil ad-hoc data requests and deliver detailed analysis of PMS data.
  12. Develop and maintain knowledge of support systems including Master Control.
  13. Perform other related duties and responsibilities as assigned.

About You

  1. Bachelor's degree, Engineering Degree, or degree in a technical field is a minimum requirement.
  2. Proficient in Windows OS, Microsoft Office Suite.
  3. Proficient in Excel in manipulation of data.
  4. Strong interpersonal skills with the ability to work in a team environment and work under own initiative.
  5. Ability to provide analysis within strict timeline requirements and assuming accountability toward delivering on agreed upon commitments.
  6. Problem solving techniques with excellent organisational skills and attention to detail.
  7. Dedication to excellence, flexibility and adaptability to change.

Preferred Knowledge And Skills

  1. Medical device experience working with Class I, II, and III devices.
  2. Familiarity with regulations including ISO 13485, CFR 11820, ISO 14971 and EU MDR.
  3. Ability to develop & maintain dashboards using BI tools.
  4. Ability to make and present risk-based decisions.
  5. Experience in technical writing and project management.
  6. Oral and written presentation skills.
  7. Ability to create, review and coordinate reports based on established guidelines and regulatory.

Click on apply if this sounds like you

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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