Job Title: Quality Assurance EngineerJob Description: The Quality Assurance Engineer is responsible for ensuring compliance with all applicable regulatory requirements, quality and industry standards, as well as company quality policies in the manufacturing of medical devices, drug products, and cosmetics. This role involves developing, implementing, and auditing quality control systems, driving continuous improvement initiatives, and providing quality/compliance-related training to ensure the highest standards of product safety, efficacy, and quality are maintained. Reporting to the Quality Manager, this position is customer-facing, fast-paced, and requires inter-departmental collaboration.Responsibilities:
Develop, implement, and maintain quality assurance programs and procedures in accordance with FDA (21 CFR 820, 21 CFR 210/211, MoCRA), ISO 13485, and other applicable regulatory requirements.
Provide cGMP, GDP, and Quality Systems training; regulatory requirements training and continuous improvement methodologies training and guidance to employees.
Conduct, manage, and participate in internal and external audit programs.
Participate in the development and maintenance of the QMS and related procedures and policies.
Handle customer complaints and manage the customer interface for quality-related issues.
Ensure the timely and effective processing of key quality drivers such as CAPAs, NCRs, OOS, APRs, Stability Program, CMRs, and Deviations.
Assist customers as required to provide quality support on projects.
Support design control activities, risk management, and process validation efforts.
Qualifications:
Bachelor’s degree in Life Sciences, Engineering, or a related technical field.
6-8 years of work-related experience in Quality Compliance, Quality Control, or quality systems within the medical device, pharmaceutical, or similar regulated industry.
Strong knowledge of FDA regulations, ISO 13485, ISO 14971, cGMP, and related industry standards.
Experience with process validation, equipment qualification, and statistical analysis tools.
Proficiency in quality tools such as FMEA, root cause analysis, Six Sigma, and Lean Manufacturing principles.
Excellent problem-solving skills, attention to detail, and ability to work under pressure in a fast-paced environment.
Effective communication (written and oral) and interpersonal skills for collaboration with internal teams and external stakeholders.
ASQ Certified Quality Engineer (CQE) or Six Sigma certification is a plus.
ISO/ASQ Auditor certification is a plus.
Benefits:
Comprehensive health benefits
Generous 401(k) plan
Flexible working hours
Remote work options
Continuous learning opportunities, including certifications and training programs
Work EnvironmentThe person will be working in a team with 2 other Quality Engineers, a Quality Control Specialist, and a Document Control Specialist. The work environment is fast-paced, involving collaboration with various departments. The role may require interfacing with customers and participating in audits. The position involves using quality management systems such as SharePoint and adhering to a professional dress code.Pay and BenefitsThe pay range for this position is $45.00 - $60.00/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 TypeThis is a fully onsite position in Dallas,TX.Application DeadlineThis position is anticipated to close on Mar 17, 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.