Quality Engineer

Actalent; Madison (WI); On-site; USD 53,000 - 106,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan - Pre-tax and R

Life Insurance (Voluntary)

Short and long-term disability

HSA

Transportation benefits

PTO / Vacation / Sick Leave

Job summary

Actalent is seeking a Quality Engineer to oversee design control quality for medical devices in Madison, WI. The role collaborates with R&D and regulatory affairs to ensure FDA and ISO compliance across design inputs, outputs, verification, validation and risk management, while supporting the QMS and CAPA processes.

The ideal candidate has 5+ years in medical devices, experience with CAPAs, nonconformance, design verification, and knowledge of ISO and 21 CFR 820; a Bachelor's in Mechanical or

Qualifications

• 5+ years in medical devices quality engineering and design control.
• Experience with CAPA, nonconformance and design verification.
• Knowledge of FDA/ISO regulations and FDA 21 CFR 820.
• Proven root cause analysis and problem solving skills.

Responsibilities

• Oversee design control quality in engineering for medical devices.
• Collaborate with R&D and regulatory affairs to ensure FDA/ISO compliance.
• Support QMS document lifecycle management and CAPA administration.
• Manage audits and drive continuous improvement of quality systems.
• Provide QA support for manufacturing, including in-process validation and nonconformance management.
• Assist with product release and equipment qualifications.

Skills

Quality engineering

Root cause analysis

Design control

Regulatory compliance

CAPA management

Medical devices experience

ISO/21 CFR 820 knowledge

Education

Bachelor's degree in Mechanical or Manufacturing Engineering

Job description

Job Title: Quality Engineer

Job Description

The Quality Engineer will be responsible for overseeing design control quality in engineering for medical devices. This role involves collaborating with R&D and regulatory affairs to ensure that design inputs, outputs, verification, validation, and design risk management activities comply with FDA and ISO regulations. Additionally, the Quality Engineer will support the quality management system by maintaining and continuously improving document lifecycle management, CAPA administration, and audit management. The position also encompasses quality engineering support for manufacturing activities, including in-process validation, nonconformance management, product release, and equipment qualifications.

Responsibilities

• Oversee design control quality in engineering for medical devices.
• Collaborate with R&D and regulatory affairs to ensure compliance with FDA and ISO regulations.
• Support the quality management system in document lifecycle management and CAPA administration.
• Manage audit processes and ensure continuous improvement of quality management systems.
• Provide quality engineering support for manufacturing activities, including in-process validation and nonconformance management.
• Participate in product release and equipment qualifications.

Essential Skills

• 5+ years of experience working with medical devices.
• 5+ years of experience with CAPAs.
• 5+ years of experience with nonconformance management.
• 5+ years of experience with design verification.
• Proficiency in quality engineering, quality assurance, and root cause analysis.
• Knowledge of supplier quality and medical device regulations.
• Experience with ISO and 21 CFR 820 standards.
• ASQ certification.

Additional Skills & Qualifications

• Bachelor's degree in Mechanical or Manufacturing Engineering.
• Experience with design history files, design verification, and quality systems management.

Job Type & Location

This is a Contract to Hire position based out of Madison, WI.

Pay and Benefits

The pay range for this position is $38.46 - $76.92/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Madison,WI.

Application Deadline

This position is anticipated to close on Sep 28, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.