Quality Engineer I

Job Title: Quality Engineer

Job Description

The Quality Engineer will support the Quality organization by leading CAPA investigations, managing non-conformance processes, and driving key quality-related projects within a regulated manufacturing environment. This position is well suited for a junior-level engineer with 1-2 years of experience who is eager to grow in an FDA-regulated industry such as medical devices or pharmaceuticals. The role offers the opportunity to take ownership of critical quality activities, collaborate with cross-functional teams, and contribute to process improvements and QMS enhancements.

Responsibilities

• Lead and manage CAPA (Corrective and Preventive Action) investigations from initiation through closure, ensuring thorough root cause analysis and effective corrective actions.
• Handle non-conformance processing and reporting, including documentation, tracking, and resolution of issues.
• Collaborate cross-functionally with Quality teams, Manufacturing, Manufacturing Sciences, and leadership stakeholders to resolve quality issues and support continuous improvement.
• Support and coordinate quality-related projects, including QMS system transitions, process improvement initiatives, and the development of new workflows and procedures.
• Facilitate meetings related to quality activities, including preparing agendas, taking detailed notes, and distributing action items and status updates.
• Maintain daily and weekly quality operations, including accurate and timely documentation in quality systems and databases.
• Apply quality engineering tools and methodologies such as FMEA, capability studies, measuring and test equipment studies, product validation, and reliability testing to assess and mitigate process-related risks.
• Support internal and external auditing activities by preparing documentation, participating in audits, and following up on findings.
• Progressively take on more independent ownership of CAPA, non-conformance, and assigned quality projects as onboarding and training milestones are achieved.
• Participate in internal training and shadowing of QA engineers during the initial ramp-up period to gain familiarity with processes, systems, and regulatory expectations.

Essential Skills

• 1+ years of related experience in an FDA-regulated environment such as medical device, pharmaceutical, or a closely related industry, with real-world experience beyond internships.
• Hands-on experience leading CAPA investigations, including responsibility for driving the process and investigations, not only participating as a team member.
• Experience with non-conformance management, including documentation, investigation, and resolution activities.
• Background in quality engineering with practical use of root cause analysis tools and methodologies.
• Exposure to manufacturing environments with an understanding of production pace, priorities, and operations.
• Familiarity with FDA regulations and ISO standards relevant to medical device or pharmaceutical industries.
• Bachelor's degree preferred in engineering or life sciences; an associate degree may be considered, but a completed degree is required for long-term conversion.
• Strong documentation skills with attention to detail and the ability to maintain accurate, compliant records.
• Ability to collaborate effectively with cross-functional teams and communicate clearly in both written and verbal forms.
• Capability to manage multiple tasks and projects in a structured and organized manner.

Additional Skills & Qualifications

• Experience with project management, including planning, organizing, and tracking quality-related initiatives.
• Familiarity with Smart Soft-QMS or similar electronic Quality Management Systems.
• Experience with assessment of process-related risks, including FMEA (Failure Modes and Effects Analysis), capability studies, measuring and test equipment studies, product validation, and reliability testing.
• Auditing experience, including participation in internal or external audits and support of audit readiness activities.
• Knowledge of ISO 13485 and related quality system requirements, with certifications in ISO 13485 considered a plus.
• Experience in medical device or pharmaceutical manufacturing environments, including knowledge of industry-specific quality and regulatory expectations.
• Demonstrated ability to support QMS system transitions and contribute to the development of new workflows and procedures.
• Strong organizational and time-management skills, with the ability to prioritize tasks in a fast-paced environment.
• Motivation to grow within a regulated industry and take on increasing responsibility over time.

Work Environment

This is a full-time, 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. You will work closely with Quality, Manufacturing, and Manufacturing Sciences teams in a regulated manufacturing setting that follows FDA and ISO requirements. The environment emphasizes structured processes, detailed record-keeping, and cross-functional collaboration to support continuous improvement and compliance.

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 - $40.00/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 Jun 5, 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 ... 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.