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Contract Quality Engineer Medical Device Jobs in Racine, WI

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 ...

Actalent

Quality Engineer

Park City, IL · On-site

$68K - $88K/yr

Experience with ISO 13485 or similar medical device quality standards. * Proficiency in statistical ... Job Type & Location This is a Contract position based out of Park City, IL. Pay and Benefits The ...

Cirtec Medical Corp.

Quality Engineer I

Sturtevant, WI

$69K - $90K/yr

Provide Quality Engineering support for engineering project development, or sustained manufacturing ... Medical Device 21 CFR 820 knowledge * Extrusion/Molding and/or manufacturing experience Salary ...

Smiths Machine

Regulatory Quality Engineer

Kenosha, WI

$70K - $90K/yr

Bachelor's degree in applicable technical discipline such as mechanical or bio-medical engineering ... Knowledge of the medical device manufacturing industry. * Knowledge of ISO 13485 Quality Management ...

ARCH Global Precision

Regulatory Quality Engineer

Kenosha, WI · On-site

$70K - $90K/yr

Bachelor's degree in applicable technical discipline such as mechanical or bio-medical engineering ... Knowledge of the medical device manufacturing industry. * Knowledge of ISO 13485 Quality Management ...

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All JobsContract Quality Engineer Medical Device JobsContract Quality Engineer Medical Device Jobs in Racine, WI

Contract Quality Engineer Medical Device information

See Racine, WI salary details

$42.2K

$78.8K

$111.6K

How much do contract quality engineer medical device jobs pay per year?

As of Sep 1, 2026, the average yearly pay for contract quality engineer medical device in Racine, WI is $78,801.00, according to ZipRecruiter salary data. Most workers in this role earn between $67,500.00 and $87,200.00 per year, depending on experience, location, and employer.

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 popular job titles related to Contract Quality Engineer Medical Device jobs in Racine, WI?

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

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

The top searched job categories for Contract Quality Engineer Medical Device jobs in Racine, WI are:

What cities near Racine, WI are hiring for Contract Quality Engineer Medical Device jobs?

Cities near Racine, WI with the most Contract Quality Engineer Medical Device job openings:

Contract Quality Engineer Medical Device jobs near you

Mechanical Engineer | Medical Devices | Waukesha, WI / Milwaukee Area (Onsite)

Milwaukee, WI • On-site

TalentOla
See more jobs at TalentOlaexternal

Contractor

Re-posted 15 days ago

Job description

Mechanical Engineer – Medical Devices / MR Systems
Location
Waukesha, WI / Milwaukee Area (5 Days Onsite)
Employment Type
Contract
Experience Required
5+ Years
 
Role Overview
We are seeking an experienced Mechanical Engineer with a strong background in mechanical product design, subsystem integration, and engineering analysis within regulated environments.
The ideal candidate will contribute to the development, analysis, optimization, and support of complex mechanical systems and components for MR (Magnetic Resonance) programs. This role requires hands-on experience in mechanical design, cross-functional collaboration, and engineering problem-solving within medical device or highly regulated industries.
Key Responsibilities
  • Support development and resolution of complex mechanical designs and technical issues across MR engineering programs.
  • Participate in technical design reviews, feasibility studies, and engineering trade-off analyses.
  • Execute mechanical design and engineering analysis activities including:
    • Structural simulations
    • Thermal analysis
    • Functional evaluations
  • Develop reliable, manufacturable, and serviceable mechanical components and subsystems.
  • Translate system and subsystem requirements into detailed mechanical designs and technical documentation.
  • Support design optimization and cost-reduction initiatives for mechanical assemblies and components.
  • Identify technical risks and collaborate with cross-functional teams to implement mitigation strategies.
  • Work closely with suppliers and manufacturing partners to support design validation, issue resolution, and production readiness.
  • Contribute to engineering standardization, reusable component strategies, and common technology initiatives across product portfolios.
  • Ensure compliance with medical device quality, safety, and regulatory standards.
Required Qualifications
Mandatory Skills
  • Bachelor’s degree in Mechanical Engineering or related discipline.
  • 5+ years of experience in:
    • Mechanical design
    • Product engineering
    • Mechanical analysis
    • Design verification
  • Experience working in:
    • Medical devices
    • Healthcare equipment
    • Regulated engineering environments
  • Strong understanding of:
    • Mechanical assemblies
    • Materials and fabrication methods
    • Mechanical integration principles
  • Experience collaborating with cross-functional engineering teams.