Supplier Quality Engineer II - Fairfield, NJ in Fairfield, NJ at Getinge

Date Posted: 6/10/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Fairfield, NJ
  • Experience:
    Not Specified
  • Date Posted:
    6/10/2019

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.

Position Overview:

The Supplier Quality Engineer is responsible for ensuring the Cardiac Assist chain provides components, assemblies and products that meet expected quality levels. Provides leadership and technical support while executing Engineering tasks as part of supplier management, validations and process improvement.  The Supplier Quality Engineer works cross functionally with Operations, Production, Engineering, Quality and Regulatory to continuously improve supplier performance.

Primary Responsibilities

  • Own supplier performance and measurement KPIs and participate in supplier performance reviews. Enable reporting of metrics for monthly reviews.
  • Lead quality issues with suppliers and partner with internal customers. Lead effective supplier containment and corrections/corrective actions.
  • Manage, track and expedite First Article Inspections and Validation activity
  • Support Implementation of Supplier process validation
  • Implement Production Part Approval Process (PPAP)
  • Define supplier objectives and design requirements
  • Drive supplier requirements and supplier performance objectives
  • Develop commodity strategies
  • Supplier Development; establish & sustain effective partnerships with suppliers, develop technical capability
  • Engage in external and internal audits as needed.
  • Ensure regulatory compliance in area of responsibility to GMP of all medical device regulatory agencies.
  • Complete first article forms and first article summary
  • Specification review: coordinate changes, clarification, harmonization
  • Initiate, review and approve change notices
  • Support cost savings, consolidation and transfer programs
  • Participate in projects and continuous improvement initiatives as assigned and lead the project through existing Design Change procedures, where necessary
  • Assist with NCMR and SCAR resolution
  • Identify and coordinate quality improvement efforts
  • Work directly with suppliers by attending/arranging local meetings, conference calls, Web meetings, and Travel as required for on-site meetings at suppliers
  • Perform the role of a Supplier Corrective Action Request Coordinator
  • Responsible for maintenance of the AVL’s and vendor qualification files
  • Responsible for maintenance of current ISO certificates.
  • Responsible for hosting MRB bi-monthly meetings
  • Responsible for Supplier Semi-Annual review.

Required Skills and Abilities:

  • Must demonstrate effective verbal and written communication skills.
  • Must demonstrate ability to exercise sound judgment, be well organized, take initiative, be flexible
  • Must work well under pressure, work effectively with both employee and management and be able to facilitate resolution of complex issues.
  • Demonstrated ability to apply sound engineering judgement.
  • Previous working knowledge of MRP or equivalent system is required.  Prior SAP experience is preferred
  • Knowledge of the principles and practices of process validation
  • A working knowledge of quality improvement tools and techniques
  • Knowledge of auditing procedures
  • Work related travel (Domestic and overseas) 10-25%

Experience and Education Requirements:

  • A Bachelor’s degree in Engineering, Science or related field is required.
  • Five (5+) years’ experience in a manufacturing environment is preferred.
  • Experience in medical device or other regulated industry (FDA Regulations, GMP’s and ISO 9000) is preferred.

Getinge Group is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.

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.