Sr. Quality Engineer, SSU Americas - Wayne, NJ in Wayne, NJ at Getinge

Date Posted: 8/4/2018

Job Snapshot

  • Employee Type:
  • Location:
    Wayne, NJ
  • Experience:
    Not Specified
  • Date Posted:

Job Description

Together we can make a difference

At Getinge we are dedicated and passionate about helping our customers save lives and ensure excellent care. We provide innovations for operating rooms, intensive-care units, sterilization departments and for life science companies and institutions. Our portfolio combines well-known product brands such as Maquet, Pulsion, Atrium, Lancer and Datascope – just to name a few.

A career at Getinge will provide career opportunities that both inspire and challenge. Here, you can make a difference every day.

Position Overview:

Develop and execute the ‘ONE Quality System’ strategy for the SSU Americas.  Continually Assess and improve SSU Americas Quality Training processes and tools. 

Job Details:

Implement and maintain processes and procedures to assure Quality Training processes and tools are compliant with global regulations and meet the needs of the business.   Support Global efforts to establish one Getinge processes and procedures for CAPA.

Quality System

  • Develop One Quality System for SSU Americas that is agile and robust to attain and maintain compliance across the spectrum of Regulations throughout the Americas Region.
  • Project Manage the One Quality System implementation
  • Create Standard Operating Procedures to maintain practical, efficient compliance to the One Getinge and SSU Americas Quality Systems requirements.
  • Establishes key metrics and an overall scorecard for Quality System processes and results. 
  • Provides leadership, mentoring, and training to all levels and functions within the SSU Organization on the Quality System principles and practices.
  • Act as Subject Matter Expert on Quality System process to external auditors.
  • This is not an inclusive list of job responsibilities.

Training Systems

  • Acts as a key driver of change within the organization, supporting peers and leaders by implementing and communicating Training requirements and educating team members on how training is a key part of compliance initiatives.
  • Conduct New Hire Quality System Training and other trainings as needed
  • Manage the daily execution of the Training process and system
  • Develop training and train teams on various Quality and Regulatory requirements throughout the Americas Region.
  • Communicates, interacts and coordinates Training efforts with SSU Leadership and QA Leadership.
  • Partner with internal resources to ensure Training is documented and completed in accordance procedures.
  • Assess Training process and tools for their ability to meet requirements including compliance, effectiveness, and robustness.
  • Supports all groups within the SSU Americas in the use of the Training process, procedures, metrics and reporting.
  • Act as Subject Matter Expert on Training process to external auditors.
  • This is not an inclusive list of job responsibilities.

Background Experience:

  • Bachelors degree in Engineering, Science or related field is required. A Masters of Science in Engineering, Science or related field is preferred. CQE (Certified Quality Engineer), Black Belt certification or CQA (Certified Quality Auditor) is desirable.
  • Minimum of five years experience in quality assurance, quality engineering or related functions or a M.S. plus 3 years experience is required.  Prior experience in a FDA regulated industry or ISO certified organization
  • Must have demonstrated proficiency in statistical analysis, the ability to analyze and solve complex problems, and the ability to communicate effectively across departments. 
  • Working knowledge of quality systems is required. Familiarity with analytical software applications is preferred. 
  • Project management and leadership experience is required.   Previous experience participating in FDA/customer/corporate audits is preferred.
  • Must demonstrate effective influencing and change management skills and demonstrated achievements in process improvements.
  • Must have demonstrated presentation, facilitation skills and the ability to interact and communicate with senior management and Sales/Service/Field staff at all levels.
  • Must have effective problem-solving, decision making, influencing and negotiation skills as well as the ability to assess the impact of regulatory strategies on business performance.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.

Getinge is an EO employer – M/F/Veteran/Disability




We look forward to receiving your application. If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application. We hope you will join us on our journey to become the world’s most desired medtech company.