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Contract 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 ...

Cadence Inc

Quality Assurance Engineer II

Sturgeon Bay, WI · On-site

$69K - $89K/yr

As a Quality Engineer II for a Contract Medical Device Manufacturing Organization, you will be responsible for ensuring that all products are manufactured and delivered according to the strictest ...

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.

Resonetics

Quality Engineering Technician

Hudson, WI · On-site

$21 - $30/hr

... medical device industry. With rapid expansion across all our locations, we continue to push the ... The Quality Engineer Technician position supports Quality Engineering techniques including: Problem ...

Resonetics

Quality Engineering Technician

Hudson, WI

$21 - $30/hr

... medical device industry. With rapid expansion across all our locations, we continue to push the ... The Quality Engineer Technician position supports Quality Engineering techniques including: Problem ...

Resonetics

Quality Engineering Technician

Hudson, WI

$21 - $30/hr

... medical device industry. With rapid expansion across all our locations, we continue to push the ... The Quality Engineer Technician position supports Quality Engineering techniques including: Problem ...

Smiths Machine

Quality Engineer II

Kenosha, WI · On-site

$70K - $90K/yr

... customer contracts (purchase orders, regulatory requirements, blueprints). • Creates PPAP ... Knowledge of the medical device manufacturing industry is highly preferred. * Experience with CNC ...

ARCH Global Precision

Quality Engineer II

Kenosha, WI · On-site

$70K - $90K/yr

... customer contracts (purchase orders, regulatory requirements, blueprints). • Creates PPAP ... Knowledge of the medical device manufacturing industry is highly preferred. * Experience with CNC ...

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All JobsContract Quality Engineer Medical Device JobsContract Quality Engineer Medical Device Jobs in Wisconsin

Contract Quality Engineer Medical Device information

What does a contract quality engineer do in the medical device industry?

A Contract Quality Engineer in the medical device industry is responsible for ensuring that products meet regulatory and company quality standards during a specific project or timeframe. They typically work on a contract basis, focusing on tasks like process validation, risk management, root cause analysis, and compliance with standards such as ISO 13485 and FDA regulations. Their role often involves collaborating with engineering, production, and regulatory teams to troubleshoot quality issues and implement corrective actions. They play a key role in maintaining product safety and regulatory compliance throughout the manufacturing process.

What are the key skills and qualifications needed to thrive as a contract quality engineer in the medical device industry?

To thrive as a Contract Quality Engineer in the Medical Device field, you need expertise in quality assurance, regulatory compliance (such as ISO 13485 and FDA regulations), and a background in engineering or life sciences. Familiarity with tools like CAPA systems, risk management software, and proficiency in quality management systems (QMS) is typically required. Strong analytical thinking, attention to detail, and effective communication skills set top performers apart in this role. These skills are essential to ensure product safety, regulatory compliance, and the successful launch and maintenance of medical devices in a highly regulated environment.

How does a contract quality engineer in the medical device industry typically collaborate with cross-functional teams?

As a Contract Quality Engineer in the medical device sector, you will frequently work closely with cross-functional teams, including R&D, manufacturing, regulatory affairs, and supply chain. Your responsibilities often involve reviewing design documentation, participating in risk assessments, and ensuring production processes meet both internal quality standards and regulatory requirements. Effective communication is key, as you'll be responsible for conveying quality expectations, addressing non-conformities, and supporting project timelines. This collaborative environment provides valuable experience in coordinating with diverse professionals while upholding strict industry standards.

What is the difference between Contract Quality Engineer Medical Device vs Contract Quality Engineer Pharmaceutical?

AspectContract Quality Engineer Medical DeviceContract Quality Engineer Pharmaceutical
CertificationsISO 13485, FDA QSR, GMPICH Q7, GMP, FDA regulations
Work EnvironmentMedical device manufacturing, labs, compliance auditsPharmaceutical production, labs, quality assurance
Industry UsageMedical device companies, OEMs, suppliersPharmaceutical firms, biotech companies, contract manufacturers

Both roles focus on quality assurance and regulatory compliance but differ mainly in industry-specific standards and environments. Contract Quality Engineers Medical Device work primarily with ISO 13485 and FDA QSR standards in device manufacturing, while Contract Quality Engineers Pharmaceutical focus on GMP and ICH Q7 regulations in drug production. Understanding these differences helps candidates target the right industry and certifications for their career goals.

What are the most commonly searched types of Quality Engineer Medical Device jobs in Wisconsin?

The most popular types of Quality Engineer Medical Device jobs in Wisconsin are:

What are popular job titles related to Contract Quality Engineer Medical Device jobs in Wisconsin?

For Contract Quality Engineer Medical Device jobs in Wisconsin, the most frequently searched job titles are:

What job categories do people searching Contract Quality Engineer Medical Device jobs in Wisconsin look for?

The top searched job categories for Contract Quality Engineer Medical Device jobs in Wisconsin are:

What cities in Wisconsin are hiring for Contract Quality Engineer Medical Device jobs?

Cities in Wisconsin with the most Contract Quality Engineer Medical Device job openings:

Contract Quality Engineer Medical Device jobs near you
Infographic showing various Contract Quality Engineer Medical Device job openings in Wisconsin as of August 2026, with employment types broken down into 1% As Needed, 77% Full Time, 17% Part Time, and 5% Contract. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution.

Medical Device Quality Engineer

Kellton Tech

Madison, WI • On-site

$40 - $45/hr

Contractor

Re-posted 18 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.