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 softwareEnsure lab equipment is qualified prior to GxP useOversee device testing, method development, method transfers, and documentation complianceParticipate in root cause analysis and implement corrective and preventive actions for manufacturing defectsRepresent Quality Assurance in test method development and lab transfer meetingsSupport development of verification and validation plans, risk management documentation, and technology transfer plansReview and approve Design History File deliverables including protocols, reports, and risk assessmentsLead lab investigations and provide compliant resolutions aligned with QMS and regulatory expectationsReview and approve complaint investigations and CAPAsAnalyze and report quality system dataDraft, review, and approve Quality Agreements with vendors and service providers

Required Skills and Knowledge

Strong understanding of ISO 14971, ISO 13485, and 21 CFR 820Familiarity with FDA and EU regulatory guidelinesExperience with cGMP standards and good documentation practicesBackground in medical device testing and injection moldingAbility to lead audits and manage cross-functional teamsProficiency in risk management and quality control processes

Qualifications

Bachelor’s degree in Engineering, Life Sciences, or a related fieldMinimum of 7 years in a regulated medical device manufacturing environment

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 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.