Job Description

Job Title: Medical Device Quality Engineer

Location: Madison, WI

Pay Rate : $40--45/hr on W2

Schedule: Onsite, Monday Friday (standard business hours)

Summary The Senior Quality Analyst/Engineer is responsible for ensuring compliance and maintaining strong Quality Systems for the Madison facility. This role oversees CAPA, Change Management, investigations, deviations, Quality Management Reviews, audit coordination, and facility-wide quality metrics. The position supports Quality System improvement initiatives, data trending, reporting, audits, and cross-functional collaboration with Regulatory Affairs, Operations, Technical Operations, Engineering, and Materials Management to strengthen quality culture.

Principal Responsibilities

• Develop and maintain Quality System processes, including metrics reporting and tracking
• Manage CAPA initiation, review, surveillance, and reporting
• Facilitate site Quality Management Reviews
• Lead and coordinate the site Change Management process
• Support and lead root cause analysis through cross-functional teams
• Lead Good Documentation Practice (GDP) training and Quality on the Floor activities
• Interpret and apply all applicable regulatory requirements
• Coordinate and support facility audits by internal and external agencies
• Manage data collection and reporting for product recalls
• Perform Quality System trending to support FDA and Management reviews
• Drive quality culture through site initiatives and procedure improvements
• Review and approve procedures, protocols, and reports as required

Additional/Non-Essential Responsibilities:

• Documentation filing and management as needed
• Support other Quality System functions
• May be required to lead personnel within or outside the Quality organization

Minimum Requirements

Education & Experience:

• Bachelor's degree (or higher) in a science or technology field preferred
• 5+ years of Quality Assurance experience in a cGMP-regulated environment (medical device experience preferred)

Skills & Competencies:

• Strong communication, coaching/mentoring, and presentation skills
• Ability to manage change effectively
• Self-motivated with strong decision-making abilities
• Project management skills with a track record of on-time delivery
• Leadership and emotional intelligence
• Moderate proficiency in statistics for data trending and interpretation

Technical Competencies:

• Proficient in Microsoft Excel, Word, and PowerPoint
• Strong technical writing skills
• Experience with statistical analysis software (e.g., Minitab preferred)

Organizational Relationship / Scope

This role collaborates closely with Manufacturing, Quality Control, Engineering, Facilities, Materials Management, Regulatory Affairs, and Process Development. Must thrive in a fast-paced environment with strict timelines. Primarily onsite Monday Friday, with occasional extended hours, weekends, or holidays to support business needs.

Working Conditions

The Senior Quality Analyst will primarily work in an office setting. Limited domestic and international travel may be required.

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