Quality Assurance Engineer

at Mallinckrodt
Location Madison, Wisconsin
Date Posted August 11, 2020
Category BioPharma
Job Type Full-time
Address 6603 Femrite Dr


Job Description

The Quality Engineer is responsible for supporting and improving the current Quality Systems within the Madison, WI manufacturing facility.  This position will have a wide range of tasks which may include deviation investigation, CAPA management, change management, internal/external auditing, and direct involvement and collaboration with the Operations, Technical Operations, Engineering, and Materials Management groups to drive quality culture.

Principal Responsibilities

  • Drive investigations and manage deviations and NCMRs from initiation to disposition
  • Manage CAPA creation and ensure adequate effectiveness
  • Perform internal and external audits of systems and suppliers
  • Perform trending of Quality Systems to support FDA and Management reviews
  • Improve quality culture through site initiatives
  • Coaching and mentoring others in regards to QMS and Quality Culture
  • Present investigations and deliver disposition recommendations
  • Improve existing procedures to align with cGMP and regulatory requirements
  • Interpret and properly apply all applicable regulatory requirements
  • Manage supplier quality
  • Perform and lead RCA’s through cross functional team involvement
  • Review and approval of procedures, protocols, reports, etc… as required.
  • May perform additional duties as required

Department specific/Non-essential responsibilities:

  • Filing and management of documentation when required
  • Supporting other Quality System Functions

Minimum Requirements

Experience / Skills:

  • Bachelor’s, or higher, degree in a scientific discipline biology, chemistry or engineering
  • 4+ years of experience in a cGMP Quality Assurance/Compliant environment (Biologics preferred)
  • Effective communication, coaching/mentoring, and presenting skills
  • Ability to manage change
  • Self-motivated
  • Project management to deliver on time results
  • Leadership skills / Emotional Intelligence


  • Proficient with Microsoft Office tools, especially Excel
  • Technical writing
  • Statistical analysis – Minitab or other software equivalent, preferred.

Organizational Relationship/Scope:

The Quality Engineer collaborates closely with Manufacturing, Quality Control, Facilities, Materials Management, Clinical Quality, Regulatory Affairs, and Process Development. The individual must be able to perform in a fast-paced environment with strict adherence to timelines. The position is during normal working hours M-F, but may be required to work extra hours or on weekends or holidays in order to support Manufacturing and Lot Release activities.

Working Conditions:

The Quality Engineer will mainly work in an office environment but will also be required to work in ISO Class 7 manufacturing and QC environment when providing QA support to those functional areas.

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