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Job Description - Quality Engineer

• Provide Quality Engineering project leadership for NPD, transfer to manufacturing, and acquisitions, as required.

• Provide Quality Engineering technical leadership in resolving quality issues.

• Review and approve validations to approve equipment, processes, and software used in the testing, processing, storing, and distribution of products.

• Collect, statistically analyze, and develop report packages to support validations and engineering studies.

• Assist in the development, implementation, and documentation of qualifications/validations to ensure that the products processed are proven to be reliable, safe, and effective prior to release.

• Perform calibration activities, as required.

• Collaborate with facilities group to ensure preventive maintenance activities are performed appropriately.

• Interface with manufacturing facilities as required.

• Ensure that all policies and procedures for the Risk Management Program are maintained.

• Work with project teams and necessary departments to identify appropriate process and product hazards, probabilities, severities, and mitigations for Risk Analyses.

• Ensure periodic reviews of Risk Management Files are performed according to schedule.

• Evaluate labeling, process, and/or product changes for their impact to the current Risk Management Files.

• Monitor post product data (e.g. Complaints, Corrective and Preventive Actions (CAPA), Non-conformance Reports (NCRs), Customer Feedback information, etc.) for impact to the Risk Management Files.

• Provide requested investigation reports/evaluations and risk assessments to other departments in a timely manner.

• Be knowledgeable on all the applicable standards, regulations, and procedures related to devices, both internal and external.

• Provide Quality Engineering project support for NPD and transfer to manufacturing.

• Create and review documents required for the Design History File.

• Perform Internal or Supplier Quality System Audits, as assigned.

• Analyze process/product non-conformances and implement comprehensive corrective and preventive action plans.

• Execute high visibility Risk Management projects for the business, as required.

• Effectively complete “other” functions that may be assigned.

• QE duties include:

• Partner with Sustaining Engineering and other cross functional groups to support successful development and commercial launch of new products.

• Partner with Sustaining Engineering and other cross functional groups to support the proper application of design controls, risk management, and the investigation/correction of design failures/challenges.

• Support determination of design input requirements as appropriate.

• Review the translation of Input requirements into design output documents.

• Accountability for sampling plans of all types including acceptability of risk given the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls etc. including assessing, applying and interpreting acceptance sampling for manufacturing data. Will take responsibility for ensuring Quality compliance throughout affected areas.

• Establish and/or maintain Risk Management Files to support product lines and corporate projects.

• Review and approve design verification / validation protocols and reports that demonstrate the design output fulfills the design input requirements.

• Conduct investigations, bounding, documentation, review and approval of non-conformances, CAPA’s and customer complaints as necessary.

Job Type & Location

This is a Contract position based out of Austin, TX.

Pay and Benefits

The pay range for this position is $50.00 - $65.00/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 Austin,TX.

Application Deadline

This position is anticipated to close on Dec 19, 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 [email protected] (%[email protected]) for other accommodation options.