Senior Quality Engineer

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Quality Engineer

The Senior Quality Engineer plays a critical role in ensuring compliance and quality across engineering and validation activities within medical device manufacturing. This includes oversight of facility, equipment, process, and software validation aligned with GxP standards.

Senior Quality Engineer

The Senior Quality Engineer plays a critical role in ensuring compliance and quality across engineering and validation activities within medical device manufacturing. This includes oversight of facility, equipment, process, and software validation aligned with GxP standards.

Key Responsibilities

• Develop and execute validation strategies for lab equipment, processes, and software
• Ensure lab equipment is qualified prior to GxP use
• Oversee device testing, method development, method transfers, and documentation compliance
• Participate in root cause analysis and implement corrective and preventive actions for manufacturing defects
• Represent Quality Assurance in test method development and lab transfer meetings
• Support development of verification and validation plans, risk management documentation, and technology transfer plans
• Review and approve Design History File deliverables including protocols, reports, and risk assessments
• Lead lab investigations and provide compliant resolutions aligned with QMS and regulatory expectations
• Review and approve complaint investigations and CAPAs
• Analyze and report quality system data
• Draft, review, and approve Quality Agreements with vendors and service providers

Required Skills And Knowledge

Qualifications

Pay And Benefits

The pay range for this position is $41.00 - $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

Workplace Type

This is a fully onsite position in Flowery Branch,GA.

Application Deadline

This position is anticipated to close on Aug 31, 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.

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 due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Seniority level

Seniority level

Mid-Senior level

Employment type

Employment type

Full-time

Job function

Job function

Quality Assurance

Industries

Business Consulting and Services

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