Quality Engineer - Manufacturing Design Transfer

Quality Engineer - Design Transfer Job Description The Quality Engineer - Design Transfer supports ongoing design and manufacturing transfer initiatives within a regulated diagnostics manufacturing environment. In this role, you ensure quality system alignment as products, processes, and systems transition from development or legacy states into full manufacturing operations. You work in close collaboration with Quality, Manufacturing Sciences, Manufacturing Engineering, Production, and Operations to enable compliant, efficient, and well-documented transfer execution, while contributing to continuous improvement across the quality management system. Responsibilities Support quality activities related to design transfer and manufacturing process transitions from development or legacy states into production environments. Assist with the transfer of documentation, workflows, and procedures into manufacturing, ensuring they are complete, accurate, and compliant. Review and update standard operating procedures (SOPs), work instructions, and quality records to align with manufacturing readiness and process changes. Partner with manufacturing and engineering teams to ensure process changes are properly documented, controlled, and implemented within the quality system. Manage and support Corrective and Preventive Action (CAPA) investigations and non-conformance processes within manufacturing operations. Perform quality record reviews, including deviations, equipment incident reports, and product containment actions, to ensure timely and effective resolution. Support ongoing initiatives related to quality management system (QMS) updates or transitions, contributing to system improvements and harmonization. Ensure compliance with applicable ISO standards and FDA Quality System Regulation (QSR) requirements throughout design transfer and manufacturing activities. Participate in internal audits and support regulatory readiness activities by providing documentation, data, and process insights. Coordinate with cross-functional stakeholders, including Quality, Manufacturing Engineering, Production, and Manufacturing Sciences, to align on project goals and deliverables. Facilitate cross-functional meetings, track action items, and support adherence to project execution timelines. Gather stakeholder input to develop workflows and implement process improvements that enhance quality and operational efficiency. Support execution of process improvement and operational efficiency projects within the manufacturing and quality organizations. Maintain oversight of day-to-day quality processes tied to manufacturing operations, helping to identify and mitigate quality risks. Support material review board (MRB) activities, CAPA review boards, and other quality review forums with data, analysis, and recommendations. Assist in establishing new quality processes or refining existing ones to strengthen the overall quality system and support scaling of manufacturing operations. Essential Skills 3+ years of experience in a manufacturing quality, quality engineering, or regulated manufacturing environment. Hands-on manufacturing experience in an operational setting (beyond purely laboratory or academic environments). Experience with design transfer and/or manufacturing transfer projects within a regulated industry. Bachelor's degree in Engineering, Life Sciences, or a related technical field. Practical knowledge of manufacturing processes and how they interface with quality systems. Familiarity with ISO-based quality management systems and regulatory quality requirements. Understanding of FDA Quality System Regulation (QSR) and its application in a diagnostics or medical device context. Experience applying root cause analysis methodologies to deviations, non-conformances, and process issues. Exposure to medical device or diagnostics manufacturing environments. Understanding of validation concepts, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Additional Skills & Qualifications Ability to interpret and improve SOPs, work instructions, and quality records for clarity and compliance. Experience supporting or participating in internal audits and regulatory readiness activities. Comfort facilitating cross-functional meetings and tracking project action items to closure. Strong analytical and problem-solving skills to support CAPA, non-conformance, and MRB activities. Ability to collaborate effectively with cross-functional teams, including Quality, Manufacturing Engineering, Production, and Manufacturing Sciences. Interest in contributing to process improvement and operational efficiency initiatives within manufacturing and quality. Motivation to grow into broader Quality Engineer ownership responsibilities and long-term career progression in quality. Strong written and verbal communication skills for documenting investigations, changes, and process updates. Work Environment This role operates within a complex diagnostics manufacturing environment that follows ISO-certified quality management standards and is subject to FDA oversight. You work closely with cross-functional teams in a production setting where quality, manufacturing, and engineering collaborate daily to support design transfer, scale-up, and ongoing operations. The environment emphasizes structured processes, thorough documentation, and adherence to regulatory requirements, offering exposure to design transfer, manufacturing scale-up, and validation activities. The culture supports continuous improvement, professional development, and a clear pathway toward broader Quality Engineer responsibilities and potential long-term career growth. 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 $45.00 - $62.50/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 24, 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 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 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.