Job Title: Quality Engineer
Job Description

We are seeking a highly skilled and experienced Quality Engineer to join our team. The ideal candidate will have a strong background in conducting root cause analysis and CAPA investigations, particularly within FDA-regulated environments. This role involves collaborating with cross-functional teams to develop corrective and preventive actions, drafting detailed investigation reports, and ensuring alignment with FDA 483 resolution requirements.

ResponsibilitiesConduct root cause analysis for each assigned CAPA.Gather and analyze data to support investigation findings.Collaborate with cross-functional teams to develop appropriate corrective and preventive actions.Draft and finalize investigation reports with clear justifications under each CAPA.Ensure alignment of CAPA documentation with FDA 483 resolution needs.Participate in internal meetings, provide status updates, and address any gaps during the investigation process.Support responses to FDA inquiries as it pertains to CAPA status, as needed.Essential SkillsRoot cause analysisCAPA investigationsData analysisDocumentationAlignment of CAPA documentation with FDA 483 resolution needsFamiliarity with aseptic filling and regulation 21 CFR 210 and 211Blow fill sealAseptic processingAdditional Skills & Qualifications5-7+ years of experience performing CAPA FDA related investigationsFamiliarity with aseptic filling and regulation 21 CFR 210 and 211Work Environment

This role is within a mid-sized medical device manufacturing company, requiring hands-on involvement in performing investigations. The work involves close collaboration with various teams and adherence to strict regulatory standards.

Pay and Benefits

The pay range for this position is $40.00 - $50.00/hr.

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 Vernon Hills,IL.

Application Deadline

This position is anticipated to close on Feb 10, 2025.

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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

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 actalentaccommodation@actalentservices.com for other accommodation options.