Quality Engineer

Mallinckrodt Pharmaceuticals•Madison, WI

About The Position

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 product complaint investigations, root cause analysis (RCA), manufacturing quality process development, maintenance, trending and reporting, deviation investigation, CAPA management, change management, internal/external auditing, supplier quality management, and direct involvement and collaboration with the Operations, Technical Operations, Engineering, and Materials Management groups to drive quality culture.

Requirements

Bachelor’s, or higher, degree in engineering or applicable science/technology program and 3+ years of experience in a cGMP Quality Assurance/Compliant environment (medical devices preferred) OR Associate’s degree with 10+ years of experience in cGMP Quality Assurance (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
Ability to travel (5-10%)
Proficient with Microsoft Office tools, especially Excel, Word and PowerPoint
Technical writing

Nice To Haves

Statistical analysis – Minitab or other software equivalent, preferred.
ASQ Certification (preferred)

Responsibilities

Perform trending and analysis of customer complaint data
Drive investigations and manage deviations and NCMRs from initiation to disposition
Perform and lead RCAs through cross functional team involvement
Support the development and maintenance of manufacturing quality control processes for new and existing production areas
Support supplier quality management with respect to desk audit and quality agreement creation, execution and review via direct customer contact
Maintain process Failure Mode and Effects Analysis for new and existing production areas
Manage CAPA creation and ensure adequate effectiveness
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.
Perform internal and external audits of systems and suppliers
Filing and management of documentation when required
Supporting other Quality System Functions