Production Quality Engineer

Company: Getinge Group ( Learn More )

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

Job Function Summary:

Job Function Summary:

The Production Quality Engineer will support production teams throughout the lifecycle of product.

Job Functions:

  • Evaluates verification and validation protocols and reports to ensure compliance to external standards and internal standards and procedures.
  • Provides expertise in risk management and analysis techniques when facilitating completion of FMEAs within a cross-functional team.
  • Maintains the design and process Failure Modes, Effects, and Criticality Analysis (FMECA) documents.
  • Leads Material Review Board (MRB) in addressing nonconforming product, determining root cause and implementing effective corrective actions.
  • Supports investigations into product, equipment or process nonconformities.
  • Evaluates risk during review of Nonconformance Reports (NCRs)
  • Participates in Process Validation and Design Transfer activities.
  • Assists in maintaining and updating the Device Master Record (DMR) and Design History File (DHF).
  • Reviews proposed Engineering Change Orders (ECOs) and Development Change Orders (DCOs) for compliance to the quality system.
  • Assists with Process Validation and Design Transfer activities.
  • Ensures the use of statistically valid sampling techniques.
  • Remediate legacy products and documentation as required.
  • Participates on CAPA teams as needed.
  • Works with Operations to ensure compliance, cleanliness, and safety on the floor.
  • Contributes to the team effort by accomplishing related tasks as necessary.
  • Required Knowledge, Skills and Abilities:

  • Good analytical and problem solving skills. 
  • High level of attention to detail and accuracy.
  • Excellent technicial writing.
  • Strong computer skills, including Microsoft Office applications (Word/Excel) and statistical software.
  • Knowledge of Quality Assurance methods, such as process validation, design of experiments, statistical process control (SPC) and protocol/report preparation. 
  • Knowledge of Root Cause Analysis (RCA).
  • Knowledge of ISO 13485 and FDA requirements (Code of Federal Regulations Title 21 Part 820).
  • Minimum Requirements: 

  • Bachelor’s Degree in Engineering or Science, or equivalent work experience.
  • A minimum of two years of Quality Management System (QMS) experience.
  • Getinge 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.

    Job Requirements