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Sr. Quality Assurance Engineer - Merrimack, NH in Merrimack, NH at Getinge

Date Posted: 5/3/2019

Job Snapshot

  • Employee Type:
  • Location:
    Merrimack, NH
  • Experience:
    Not Specified
  • Date Posted:

Job Description

Job Function Summary:

Provide Project Management and Quality Assurance oversight to CAPA activities and other activities within the Quality Compliance department.

Job Functions:

  • CAPA Team Leadership
    • Act as project manager to ensure CAPA activities and timelines are agreed upon, communicated, managed, and completed/met
  • Ensure CAPA activities are performed per procedures and regulations
  • Drive problem definition and scoping of CAPAs to assure that the CAPAs appropriately address underlying issues
  • Lead failure investigations and root cause analyses
  • Guide teams in documenting Verification of Effectiveness criteria per procedure
  • Perform CAPA verification of implementation and verification of effectiveness activities
  • Support external audits in various roles as assigned: scribe, backroom technical support, file preparation, and auditor facilitator
  • Prepare documentation needed to fulfill requests from customers (internal and external)
  • Update procedures and other documentation as needed to ensure continued compliance with regulations
  • Perform other duties, as assigned

Required Knowledge, Skills and Abilities:

  • Great communication and organizational skills
  • Expertise in root cause analysis techniques
  • Demonstrated ability to manage projects involving cross-functional membership
  • Microsoft Office intermediate user of Word, Excel and Power Point

Minimum Requirements:

  • Bachelor’s degree in engineering discipline, or equivalent experience
  • Minimum 3 years’ experience with CAPA

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.