Quality Systems Engineer II/III

Do you want to join one of the World's Most Admired Companies? Are you looking to be part of a dynamic and growing organization, who's company culture is centered on empowering its employees to make decisions? As one of the world's largest electronic manufacturing & supply chain logistics companies, Jabil is focused on hiring the best people!

 

About Our Company

NP Medical Inc., a subsidiary of Nypro, a Jabil company, is an innovator and supplier of medical devices that address the large-scale needs of the infusion therapy and vascular access markets. The goal that motivates us every day is to provide compelling product solutions that make quality patient care possible by improving patient outcomes and caregiver safety at an affordable cost. It is a deep understanding of the consequence of our work that has fueled NP Medical’s product innovation, guided our daily operations, and defined our customer and caregiver engagement for over thirty years. This rich tradition has produced an enduring and winning culture marked by excellence, compassion, and collaboration that extends to our customers, caregivers, and patients alike.

 

Job Summary

This position has the responsibility and authority to support the day-to-day activities within the Quality System processes. In addition, this role will assist internal audits, customer audits, ISO Registration audits, and FDA Inspections.  

 

Essential Duties & Responsibilities

  • Be a Champion and subject matter expert for the Quality Systems and Compliance processes.
  • Assist the Quality Systems Manager in ensuring the site’s quality system development, effective maintenance, and continued compliance with business unit requirements, medical device regulations and standards (i.e., U.S. – FDA, ISO 13485, EU MDR)
  • Support department activities within the Quality Systems function (i.e., Document and Data Control, Records Retention, Training, Corrective and Preventive Action, Complaint handling, Supplier Audits, Supplier Corrective Action Requests, Electronic System Development/Validation, Management Review, Risk Management, Auditing, Agency Inspections and Quality Improvement Initiatives)
  • Support the follow-up, negotiation and resolution of issues regarding current and future submissions with appropriate regulatory agencies and ISO registrars.
  • Continue to develop and enhance current regulatory knowledge at the local, national and international levels to support surveillance activities.
  • As needed, provide support for currently marketed products including review of engineering changes, labeling, promotional material, product changes and documentation of changes requiring government approval.
  • Responsible for proposing and execution of Quality System improvement opportunities.
  • Assist in establishing, maintaining, and reporting Quality System metrics.
  • Support the effectiveness of the Quality Systems and Compliance programs by working with other stakeholders to ensure effective and compliant processes.
  • Perform all duties in alignment with the Jabil Corporate Code of Ethics, Corporate and Global policies, Employment Labor Laws, Health Regulatory Agency Regulations, and Safety Requirements.

 

Job Qualifications

  • Knowledge of the U.S. and international medical device quality system regulations, standards and best practices (21 CFR 820, ISO 13485, EU MDR 2017/745)
  • Formal root cause analysis experience
  • Some experience with compliance assessments, gap assessments and risk management assessments.
  • Some experience with audits
  • Experience with program change management practices, lean or six sigma, program and system integration efforts
  • Excellent written and oral communication skills
  • Strong computer skills: Word, Excel, PowerPoint
  • Strong leadership, collaboration, and relationship building skills are required. Must be an effective team player intra-departmentally and cross-functionally, influencing change without alienating others.

 

Education & Experience Requirements

  • Bachelor’s degree required (Quality, Regulatory, Engineering, Business or Life Sciences)
  • 2-4 years of experience within Quality in a regulated industry.
  • American Society of Quality, Certified Quality Auditor (CQA) credentials, is desired.

 

Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identify, age, disability, genetic information, veteran status, or any other characteristic protected by law.