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 + Strong understanding of ISO 14971, ISO 13485, and 21 CFR 820 + Familiarity with FDA and EU regulatory guidelines + Experience with cGMP standards and good documentation practices + Background in medical device testing and injection molding + Ability to lead audits and manage cross-functional teams + Proficiency in risk management and quality control processes Qualifications + Bachelor’s degree in Engineering, Life Sciences, or a related field + Minimum 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.