Senior Quality Engineer – Medical Device (Madison, WI)

at Mallinckrodt
Location Madison, Wisconsin
Date Posted March 10, 2021
Category Biomanufacturing
Job Type Full-time
Address 6603 Femrite Dr


Job Title

Senior Quality Engineer - Medical Device (Madison, WI)


JR000011160 Senior Quality Engineer - Medical Device (Madison, WI) (Open Date: 01/26/2021)


CC-Madison - USA503

Additional Locations

Madison, WI

Job Description


The Senior Quality Engineer is responsible for leading and improving the current Quality Systems within the Madison, WI manufacturing facility.  This position will have a wide range of tasks which may include manufacturing quality process development, maintenance, trending and reporting, 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

  • Develop and maintain manufacturing quality control processes for new and existing production areas
  • Develop and maintain process Failure Mode and Effects Analysis for new and existing production areas
  • Drive investigations and manage deviations and NCMRs from initiation to disposition
  • Perform and lead RCA’s through cross functional team involvement
  • Manage CAPA creation and ensure adequate effectiveness
  • Perform trending of Quality Systems to support FDA and Management reviews
  • Coaching and mentoring others in regards to QMS and Quality Culture
  • Present investigations, perform risk analysis, and deliver disposition recommendations
  • Improve existing procedures to align with cGMP and regulatory requirements
  • Interpret and properly apply all applicable regulatory requirements
  • Improve quality culture through site initiatives
  • Review and approval of procedures, protocols, reports, etc… as required.

Department specific/Non-essential responsibilities:

  • Perform internal and external audits of systems and suppliers
  • Filing and management of documentation when required
  • Supporting other Quality System Functions
  • This role may be required to lead personnel (inside and outside) the Quality organization in support of the business need

Minimum Requirements

Experience / Skills:

  • Bachelor’s, or higher, degree in engineering or applicable science/technology program
  • 7+ years of experience in a cGMP Quality Assurance/Compliant environment (medical devices preferred)
  • Effective communication, coaching/mentoring, and presenting skills
  • Ability to manage change
  • Self-motivated
  • Independent and sound decision making capabilities
  • Project management to deliver on time results
  • Leadership skills / Emotional Intelligence
  • Ability to utilize statistics at a moderate level for trending and interpretation of statistical data


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

Organizational Relationship/Scope:

The Senior Quality Engineer collaborates closely with Manufacturing, Quality Control, Facilities, Materials Management, 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 Quality activities.

Working Conditions:

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

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