Quality Engineer

Quality Engineer

Job Description

The Quality Engineer applies quality engineering and quality assurance principles to support new product development and ongoing product lines in a highly regulated environment. This role ensures that all activities related to the receipt, storage, manufacture, testing, and distribution of products comply with applicable federal, industry, and corporate procedures, guidelines, and regulations. The position provides technical and project leadership for validation and quality initiatives, with a strong focus on validating quality control (QC) equipment and supporting design controls, risk management, and continuous improvement.

Responsibilities

• Provide quality engineering project leadership for new product development and the transfer of products into manufacturing.
• Provide technical quality engineering leadership to identify, troubleshoot, and resolve quality issues across products and processes.
• Create, review, and approve protocols, process validations, and product validations, including IQ/OQ/PQ activities for QC equipment.
• Create, review, and approve documents required for the Design History File to ensure compliance with design control requirements.
• Analyze process and product non-conformances and implement comprehensive corrective and preventive action (CAPA) plans.
• Perform internal and supplier quality system audits as assigned to verify compliance with quality system regulations and standards.
• Develop Validation Master Plans and Validation Project Plans to identify and schedule all validation tasks needed to support operational areas and corporate projects.
• Develop, conduct, and document qualifications and validations to ensure products and processes are reliable, safe, and effective prior to release.
• Assess equipment changes to determine validation needs and ensure appropriate qualification activities are completed.
• Coordinate, execute, and schedule validation activities in support of corporate and site-level projects.
• Interface effectively with manufacturing facilities and cross-functional teams to support quality and validation initiatives.
• Partner with cross-functional groups to ensure successful development and commercial launch of new products.
• Partner with cross-functional groups to ensure proper application of design controls, risk management, and investigation and correction of design failures and challenges.
• Review and approve design input requirements and ensure they are complete, clear, and testable.
• Review and approve the translation of design input requirements into design output documents.
• Take accountability for sampling plans of all types, including evaluating risk based on product classification, defect types, defect frequency, severity, patient risk, process capability, and process controls, and apply and interpret acceptance sampling for manufacturing data.
• Lead the development of risk management documents, including Failure Modes and Effects Analyses (FMEAs), as appropriate.
• Review and approve design verification and validation protocols and reports to confirm that design outputs fulfill design input requirements.
• Review, approve, and validate test methods to ensure they are robust, repeatable, and appropriate for their intended use.
• Conduct investigations and define appropriate bounding, documentation, review, and approval of non-conformances, CAPAs, and customer complaints as necessary.
• Implement systemic changes within the quality system to enhance product quality and improve business efficiency.
• Effectively complete other related quality engineering and validation functions as assigned.

Essential Skills

• Bachelor’s degree in Engineering or a science field, or equivalent relevant work experience.
• 4 years of hands-on experience in quality engineering, validation engineering, or closely related roles.
• Experience working in an FDA-regulated industry, preferably in pharmaceutical, biomedical, or medical device manufacturing.
• In-depth knowledge of current Good Manufacturing Practices (cGMP), Quality System Regulations (QSR), and ISO standards applicable to regulated industries.
• Strong knowledge and practical application of statistical methods and acceptance sampling within a regulated manufacturing environment.
• Specific experience designing, preparing, executing, and statistically analyzing validations for equipment, processes, and software used in the receipt, testing, processing, storing, and distribution of raw materials, components, and products.
• Demonstrated ability to develop and compile comprehensive validation report packages for approval of equipment, processes, and software.
• Ability to understand and work within Quality Management Systems (QMS) and implement systemic improvements to enhance product quality and business efficiency.
• Hands-on experience with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for QC or manufacturing equipment.
• Experience with test method validation, including establishing and verifying test method capability and suitability.
• Working knowledge of Geometric Dimensioning and Tolerancing (GD&T).
• Experience with Gauge Repeatability and Reproducibility (GR&R) studies.
• Experience using or supporting Coordinate Measuring Machines (CMMs), including related QC software.
• Experience with X-ray inspection systems, dye penetrant testing equipment, and metallography preparation and analysis equipment.
• Strong analytical and problem-solving skills with the ability to investigate and resolve complex quality issues.
• Ability to collaborate effectively with cross-functional teams and communicate technical information clearly in both written and verbal form.

Additional Skills & Qualifications

• ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) certification preferred but not required.
• Experience supporting medical device or pharmaceutical manufacturing environments.
• Experience leading or participating in risk management activities, including FMEAs and related risk control documentation.
• Familiarity with customer complaint handling, non-conformance management, and CAPA systems.
• Experience performing internal and supplier quality system audits.
• Comfort working with a range of QC equipment and related software tools.
• Ability to manage multiple validation and quality projects simultaneously and meet established timelines.
• Strong attention to detail and a commitment to maintaining high quality and compliance standards.

Work Environment

This is an onsite position in a regulated manufacturing and quality control environment. The role involves frequent interaction with QC laboratories, manufacturing areas, and engineering teams, including hands-on work with Coordinate Measuring Machines (CMMs), X-ray inspection systems, dye penetrant testing equipment, metallography preparation and analysis equipment, and related quality control software. The work setting emphasizes compliance with cGMP, Quality System Regulations, and ISO standards, with structured procedures and documentation requirements. The position may require time in production and lab areas where appropriate personal protective equipment (PPE) and adherence to site safety and cleanliness protocols are expected.

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

The pay range for this position is $50.00 - $67.00/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)

This is a fully onsite position in Austin,TX.

This position is anticipated to close on Jun 19, 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.

Salary : $50 - $67