Senior Quality Engineer

Job Title:

Senior Quality Engineer Job Description The Senior Quality Engineer supports and leads quality operations within a regulated manufacturing environment, ensuring strict compliance with FDA and ISO standards. This role focuses heavily on CAPA ownership, non-conformance management, and day-to-day quality system execution, while also contributing to cross-functional projects, process validation, and ongoing process and system improvements. Responsibilities Lead CAPA investigations from initiation through root cause analysis, corrective and preventive action planning, implementation, effectiveness verification, and closure. Review, manage, and approve non-conformances and quality records, including equipment-related incidents, ensuring timely and compliant documentation. Support daily quality operations in a fast-paced manufacturing environment, providing real-time guidance to resolve quality issues on the production floor. Participate in and help facilitate quality review boards such as Material Review Board (MRB) and CAPA review meetings, preparing data and documentation for decision-making. Draft, review, and maintain validation documentation, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Test Method Validation (TMV). Assist with process validation and equipment qualification activities, ensuring that protocols, reports, and supporting data meet regulatory and internal requirements. Support risk management activities, including participation in Failure Modes and Effects Analysis (FMEA) and alignment with applicable ISO standards. Coordinate cross-functional activities across Manufacturing, Research and Development (R D), and Quality teams to drive issue resolution and continuous improvement. Support multiple small projects related to Quality Management System (QMS) improvements, process optimization, and system or workflow updates. Analyze quality and manufacturing data to identify trends, recurring issues, and opportunities for corrective and preventive actions and continuous improvement. Contribute to internal audits and compliance activities, supporting audit preparation, execution, and follow-up actions. Review and approve quality documentation and records to ensure accuracy, completeness, and alignment with regulatory and company standards. Coordinate meetings, track action items, follow up on commitments, and communicate status and risks across teams and stakeholders. Operate effectively in a fast-paced environment with shifting priorities, managing multiple tasks and projects simultaneously while maintaining high quality standards. Support ongoing quality and process improvement initiatives, including participation in system transitions and enhancements to QMS tools and workflows. Essential Skills Quality engineering experience in a regulated manufacturing environment. Hands-on experience leading CAPA investigations, not only supporting them, including root cause analysis and corrective action planning. Experience managing, reviewing, and approving non-conformances and related quality records. Experience working in an FDA-regulated environment such as medical device, pharmaceutical, food and beverage, or aerospace. Manufacturing experience within a regulated environment, working closely with production teams. Strong understanding of Quality Management Systems (QMS) and quality documentation requirements. Proficiency with root cause analysis methods and corrective and preventive action planning. Ability to work cross-functionally with Manufacturing, R D, and Quality teams and manage multiple priorities in a fast-paced setting. Exposure to validation activities, including IQ, OQ, and PQ. Familiarity with ISO standards relevant to quality systems and risk management. Bachelor's degree preferred in engineering or life sciences; an associate degree may be considered with the expectation of obtaining a degree for long-term conversion. Additional Skills & Qualifications Experience with process validation and equipment qualification, including development and execution of

IQ/OQ/PQ

protocols and reports. Familiarity with risk management tools and methodologies, such as FMEA, in alignment with ISO requirements. Experience in medical device or pharmaceutical industries is strongly preferred. Exposure to supplier quality activities and supplier-related audits. Experience supporting process improvement initiatives or transitions between QMS tools or workflows. Knowledge of SmartSolve or similar electronic QMS platforms is a plus. 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. 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, data analysis, and cross-functional coordination. The role also involves regular interaction with manufacturing areas and collaboration with operations, R D, and quality teams in a fast-paced, regulated environment. 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 27, 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.