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Senior Quality Engineer, SSU Americas - Wayne, NJ in Wayne, NJ at Getinge

Date Posted: 2/8/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Wayne, NJ
  • Experience:
    Not Specified
  • Date Posted:
    2/8/2019

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.

Job Function Summary:

Develop and execute the Service Quality strategy for the Canada SSU.  Maintain positive communications with Health Canada and assist the Business Category Units with attaining and sustaining product licensing.

Job Functions: (Primary “essential” duties and responsibilities)

  • Execute the one Getinge Sales & Service group Strategy
  • Implement and maintain processes and procedures to assure the Internal Audit process and procedures are compliant with global regulations and meet the needs of the business.   Support Global efforts to establish one Getinge processes and procedures for CAPA.
  • Acts as a key driver of change within the organization, supporting peers and leaders by communicating Internal Audit process improvement efforts to employees and educating team members in understanding how Internal Audit fits into the organization's continuous improvement initiatives.
  • Create Internal Audit process and Standard Operating Procedures to maintain practical, efficient compliance to all Regulatory requirements.
  • Conduct Internal Audits at Facilities throughout the USA.
  • Report out on Internal Audit results for each audit and at Management Reviews.
  • Support CAPA Review Board and CAPA process.
  • Establishes key metrics and an overall scorecard for input to the CAPA processes.
  • Support CAPA efforts including the monitoring and analysis of processes and data to identify and initiate CAPAs.
  • Can lead CAPA management efforts to ensure that corrective and preventive actions are issued as required, properly investigated, documented, effective, and completed on time.
  • Partner with internal resources to ensure CAPAs are properly performed, documented, and completed in accordance procedures.

Required Skills and Abilities:

  • 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.

Experience and Education Requirements:

  • Bachelor’s degree in Engineering, Science or equivalent required. A Master’s of Science in Engineering, Science or equivalent is preferred.  CQA (Certified Quality Auditor), Black Belt certification or CQE (Certified Quality Engineer) 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

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

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#LI-CA1

INDCA

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.