Senior Quality Engineer

Sr. Quality Engineer

Quality Engineer will support the Healthcare business by developing and executing engineering and validation strategies, plans, and protocols. This includes overseeing facility, equipment, process, and software validation. The role ensures that quality processes are in place for the qualification of lab equipment and fixtures, and guarantees that device testing, method development, transfers, and documentation comply with applicable regulations.

Responsibilities

• Provide Quality oversight to ensure quality processes for lab equipment qualification prior to GxP activity.
• Ensure device testing, method development, method transfers, and documentation comply with regulations.
• Identify and control manufacturing process defects by participating in root cause analysis and implementing corrective actions.
• Actively participate in test method development and transfer meetings, ensuring compliance with procedures.
• Support the development of plans for development, verification/validation, technology transfer, and risk management for medical device products.
• Provide Quality oversight for Design History File deliverables, including Verification and Validation Protocols and Reports, Risk Management deliverables, and Transfer Plans.
• Support root cause investigations, providing compliant solutions for lab technical and quality issues.
• Review and approve complaint investigations, root cause analyses, and CAPAs.
• Analyze, trend, and report data supporting the quality system.
• Draft, review, and approve Quality Agreements for equipment vendors, method developers, and service providers.

Essential Skills

• 7+ years of experience in medical device quality control in a regulated manufacturing environment.
• Expertise in ISO standards, 21 CFR 820, and regulatory quality control.
• Mastery of SOPs, cGMPs, and regulatory guidelines (FDA, EU).
• Proficiency in risk management and quality assurance.
• Strong understanding of good documentation practices and cGMP standards.

Additional Skills & Qualifications

• BS degree required.
• Experience in managing within a regulatory environment.
• Familiarity with FDA and EU regulatory guidelines.

Work Environment

You will work in a brand new, clean facility in Flowery Branch, which will eventually be FDA regulated. The facility supports drug delivery, surgical, and industrial products and may expand into consumer products in the future. The site features state-of-the-art automated machines and robots. This is a high-priority site with a focus on becoming a Surgical Center of Excellence. Employees have the opportunity to be part of the initial growth stages and make a significant impact.

Job Type & Location

This is a Contract to Hire position based out of Flowery Branch, Georgia.

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:

• 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 Flowery Branch,GA.

Application Deadline

This position is anticipated to close on Sep 5, 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.