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.
Principal Responsibilities:
• Perform trending and analysis of customer complaint data
• Drive investigations and manage deviations and NCMRs from initiation to disposition
• Perform and lead RCA’s through cross functional team involvement
• Support the development and maintenance 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.
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
Minimum Requirements
Experience / Skills:
• Bachelor’s, or higher, degree in engineering or applicable science/technology program
• 3+ 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
Competencies:
• 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, 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 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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