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Temp Quality Engineer Medical Device Jobs in Wisconsin

Kellton Tech

Medical Device Quality Engineer

Madison, WI · On-site

$40 - $45/hr

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 ...

Werfen

Quality Engineer - Systems Assurance

Waukesha, WI · On-site

$90 - $130/hr

Quality Assurance Systems Engineer(Systems QA / Compliance / Engineering / Medical Device / Health Care) Responsibilities Key Accountabilities CAPA Management: * Oversee the end-to-end CAPA process ...

Verily Life Sciences LLC

WI · On-site

$113 - $170/hr

Senior Quality Engineer, Cybersecurity The Senior Quality Engineer, Cybersecurity is a hands-on ... Proven expertise in medical device cybersecurity, including working knowledge of FDA premarket and ...

Kellton Tech

Medical Device Assembler

Madison, WI · On-site

$23 - $24/hr

Ensure work is completed in compliance with company quality system and medical device regulations ... Engineering group as required. Working Conditions: Clean, temperature controlled environment.

Haemonetics Software Solutions

WI · On-site

$51 - $87/hr

Assist the quality team with data collection and timely reporting to facilitate performance ... BS in Electrical/Electronic Engineering, Mechanical Engineering, related degree with knowledge in ...

MGS Mfg. Group, Inc

Quality Engineer

Richfield, WI · On-site

$71K - $92K/yr

As a Quality Engineer at MGS, you will assist with the development of quality systems, procedures ... Approve Medical Device release for shipment, as required. * * Perform batch record reviews for ...

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Temp Quality Engineer Medical Device information

What is the difference between Temp Quality Engineer Medical Device vs Temp Quality Technician Medical Device?

AspectTemp Quality Engineer Medical DeviceTemp Quality Technician Medical Device
CredentialsBachelor's in Engineering, Quality or related field; certifications like CQE often preferredHigh school diploma or associate degree; technical certifications beneficial
Work EnvironmentDesign, develop, and improve quality systems; collaborate with engineering teamsPerform inspections, testing, and documentation; support quality assurance processes
Employer & Industry UsageUsed in medical device manufacturing companies for process developmentCommonly employed in quality control labs and manufacturing lines

The Temp Quality Engineer Medical Device focuses on developing and improving quality systems, requiring more technical expertise and engineering knowledge. In contrast, the Temp Quality Technician Medical Device primarily handles testing, inspections, and documentation tasks. Both roles are essential in ensuring product quality but differ in responsibilities and required qualifications.

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Medical Device Quality Engineer

Kellton Tech

Madison, WI • On-site

$40 - $45/hr

Contractor

Re-posted 24 days ago

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)

SummaryThe 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.