Quality Engineer 1

Job Title:

Quality Engineer I Job Description The Quality Engineer I supports quality operations in a regulated manufacturing environment and ensures compliance with FDA and ISO standards. This role focuses heavily on owning CAPA activities, managing non-conformances, and executing day-to-day quality system processes. The position also contributes to cross-functional projects, process validation, risk management, and continuous improvement initiatives across Manufacturing, R D, and Quality teams. Responsibilities Lead CAPA investigations from initiation through closure, including root cause analysis, corrective and preventive action planning, and effectiveness verification. Review, manage, and maintain non-conformance records and other quality records, including equipment-related incidents, ensuring timely and compliant documentation. Support daily quality operations in a fast-paced manufacturing environment, addressing issues in real time and ensuring adherence to quality procedures. Participate in and help facilitate quality review boards such as Material Review Board (MRB) and CAPA review meetings, including preparing materials and tracking outcomes. Draft, review, and maintain validation documentation, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Test Method Validation (TMV). Coordinate cross-functional activities and communications among Manufacturing, R D, and Quality teams to resolve issues and support project execution. Assist with process validation, equipment qualification, risk management activities (such as FMEA), and design transfer efforts to manufacturing. Support ongoing quality and process improvement initiatives, including updates to quality systems, workflows, and procedures. Analyze quality and process data to identify trends, drive continuous improvement actions, and support decision-making. Contribute to internal audits and compliance activities by preparing documentation, supporting audit execution, and following up on action items. Review and approve quality documentation and records to ensure completeness, accuracy, and regulatory compliance. Coordinate meetings related to quality activities, track action items, and ensure clear communication and follow-up across teams. Support multiple small projects related to Quality Management System (QMS) improvements and process optimization. Work closely with manufacturing teams to resolve quality issues promptly and maintain product and process compliance. Operate effectively in a fast-paced environment with shifting priorities while managing multiple tasks and projects. Essential Skills 1+ year of experience working in an FDA-regulated environment such as medical device, pharmaceutical, food and beverage, or aerospace. Hands-on experience leading CAPA investigations, not only supporting them. Experience managing or reviewing non-conformances and related quality records. Manufacturing experience in a regulated environment with exposure to shop floor or production operations. Strong understanding of quality systems (QMS) and quality documentation requirements. Practical knowledge of FDA regulations and ISO standards relevant to regulated manufacturing. Proficiency in root cause analysis and development of corrective and preventive action plans. Ability to work cross-functionally with Manufacturing, R D, and Quality teams. Ability to manage multiple priorities and operate effectively in a fast-paced environment. Bachelor's degree preferred, ideally in engineering or life sciences. Experience with process validation or equipment qualification (IQ/OQ/PQ). Familiarity with risk management tools and methods such as FMEA and ISO-based risk frameworks. Exposure to medical device or pharmaceutical industry quality practices. Knowledge of supplier quality concepts and participation in audit activities. Additional Skills & Qualifications Experience supporting process improvement initiatives or transitions of quality systems and workflows. Familiarity with SmartSolve or similar electronic Quality Management System (eQMS) tools. Audit experience, including participation in internal or external audits. Quality-related certifications such as Certified Quality Engineer (CQE) or Six Sigma are preferred but not required. Exposure to ISO-based quality management systems and related compliance activities. Strong communication skills to facilitate meetings, coordinate actions, and document outcomes clearly. Detail-oriented approach to documentation, investigations, and record-keeping. Work Environment This is an onsite role with standard hours of 8:00 a.m. to 5:00 p.m., Monday through Friday. The position is primarily desk-based with a heavy focus on documentation, investigations, and coordination activities. The Quality Engineer I works closely with manufacturing and cross-functional teams in a regulated manufacturing facility, using quality systems and tools to manage CAPAs, non-conformances, validations, and audits. The environment is fast-paced, with shifting priorities and multiple concurrent projects, requiring strong organizational skills and comfort with frequent collaboration and communication. Job Type & Location This is a Contract to Hire position based out of Austin, TX. Pay and Benefits The pay range for this position is $36.00 - $45.67/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 Austin,TX.

Application Deadline This position is anticipated to close on Jun 29, 2026. 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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service. 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 for other accommodation options.

San Francisco Fair Chance Ordinance:

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector:

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.