Quality Engineer

Job Title: Quality Engineer Job Description The Quality Engineer leads design control quality activities for medical devices, partnering closely with research and development and regulatory affairs to ensure design inputs, outputs, verification, validation, and design risk management comply with FDA and ISO regulations. This role supports the quality management system by maintaining and continuously improving document lifecycle management, CAPA administration, and audit management. The Quality Engineer also provides quality engineering support for manufacturing, including in-process validation, nonconformance management, product release, and equipment qualifications. Responsibilities

- Own and lead design control quality activities for medical device engineering projects.
- Partner with research and development and regulatory affairs to ensure design inputs and outputs comply with FDA and ISO regulations.
- Plan, execute, and document design verification and validation activities in accordance with regulatory and quality system requirements.
- Lead and maintain design risk management activities, ensuring risks are identified, analyzed, mitigated, and documented appropriately.
- Support and enhance the quality management system, focusing on document lifecycle management and continuous improvement.
- Administer and manage corrective and preventive action (CAPA) processes, including investigation, root cause analysis, implementation of corrective actions, and effectiveness checks.
- Manage and support internal and external audit activities, including preparation, execution, response, and follow-up actions.
- Provide quality engineering support for manufacturing processes, including in-process validation and process improvements.
- Lead and manage nonconformance investigations, including documentation, root cause analysis, and disposition.
- Support product release activities by reviewing quality records and ensuring compliance with applicable standards and procedures.
- Oversee and support equipment qualification activities to ensure equipment used in manufacturing and testing is properly validated and maintained.
- Collaborate with supplier quality and other cross-functional teams to maintain robust quality systems and consistent product quality.
- Apply root cause analysis methodologies to resolve quality issues and prevent recurrence.
- Maintain and update design history files and other quality records to ensure completeness, accuracy, and regulatory compliance.

Essential Skills

- 5+ years of experience working with medical devices.
- 5+ years of experience with CAPA processes, including investigation, root cause analysis, and corrective action implementation.
- 5+ years of experience with nonconformance management.
- 5+ years of experience with design verification activities for medical devices.
- Proven experience in quality engineering and quality assurance within a regulated environment.
- Hands-on experience with design control elements, including design inputs, design outputs, design verification, design validation, and design risk management.
- Strong knowledge of medical device regulations, including FDA 21 CFR 820.
- Working knowledge of ISO standards relevant to medical devices and quality management systems.
- Experience with quality systems management and quality system documentation.
- Proficiency in root cause analysis methodologies and tools.
- Experience with CAPA administration and corrective action planning.
- Familiarity with design history files and associated documentation requirements.
- Bachelor’s degree in Mechanical Engineering or Manufacturing Engineering.
- ASQ certification or equivalent professional quality certification.

Additional Skills & Qualifications

- Experience working with supplier quality processes in a medical device environment.
- Background in engineering disciplines relevant to medical device design and manufacturing.
- Experience with document lifecycle management within a quality management system.
- Exposure to audit management, including internal and external audits.
- Ability to collaborate effectively with cross-functional teams, including R&D, regulatory affairs, and manufacturing.
- Strong written and verbal communication skills for documenting quality activities and presenting findings.
- Detail-oriented approach with a focus on regulatory compliance and continuous improvement.
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 30, 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 [email protected] 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.