Quality Engineer

Job Title: Quality Engineer (Contract)Job Description

This short-term Quality Engineer contract role (approximately six months) focuses on providing critical Quality Assurance support by clearing a backlog of investigations and contributing to key QA activities in a regulated environment. You will lead and support investigations related to nonconformances, CAPAs, and complaints, while also assisting with document control, batch release, and document reviews to ensure a full and varied workload throughout the contract. The position requires strong experience in medical devices or similarly regulated industries, excellent root cause analysis capabilities, and clear, precise technical writing skills.

Responsibilities

• Lead and support investigations for nonconformances (NC), CAPAs, and complaints to address a backlog of quality issues in a timely and compliant manner.
• Perform thorough root cause analysis using structured problem-solving methods to identify underlying causes of quality issues and recommend effective corrective and preventive actions.
• Document investigations clearly and accurately, producing high-quality technical reports that meet regulatory and internal quality standards.
• Support additional Quality Assurance activities such as document control, ensuring controlled documents are current, accurate, and properly maintained within the QMS.
• Participate in batch release activities by reviewing relevant documentation for completeness, accuracy, and compliance with applicable standards and procedures.
• Conduct detailed document reviews of procedures, technical documentation, and records to verify compliance with internal quality requirements and regulatory expectations.
• Collaborate closely with the Quality Assurance team and cross-functional partners, including R&D, service, and operations, to gather information and ensure alignment on investigation findings and actions.
• Review and interpret quality system procedures, technical documents, and regulatory requirements to support robust and compliant investigation practices.
• Utilize the QMS system (Qdocs) to manage investigations, documentation, and quality records in an organized and traceable manner.
• Contribute to continuous improvement initiatives within the quality system by identifying trends, recommending process improvements, and supporting implementation of enhanced QA practices.

Essential Skills

• At least 5 years of experience working as a Quality Engineer or QA professional, with a strong focus on investigations.
• Proven experience conducting investigations involving nonconformances (NC), CAPAs, and complaints in a regulated environment.
• Strong understanding of general root cause analysis methodologies and their application to quality issues.
• Excellent technical writing skills, with the ability to produce clear, concise, and well-structured investigation reports and quality documentation.
• Experience working within a Quality Management System (QMS), including use of electronic systems such as Qdocs or similar platforms.
• Background in medical devices is preferred, or substantial experience in a regulated industry such as pharmaceuticals, biotechnology, or other FDA-regulated sectors.
• Knowledge of FDA regulations and expectations related to quality systems, investigations, and CAPA processes.
• Familiarity with ISO standards relevant to quality and medical devices (such as ISO-based QMS frameworks).
• Experience with quality control practices and principles in a regulated environment.

Additional Skills & Qualifications

• Experience in a medical device environment, including understanding of device lifecycle, risk management, and post-market quality activities.
• Exposure to ISO-based quality standards and their application in daily QA activities.
• Comfort working with cross-functional teams including R&D, service, and operations to gather data and implement corrective and preventive actions.
• Ability to quickly learn and adapt to site-specific QMS tools, including Qdocs, and local procedures.
• Strong attention to detail and organizational skills to manage multiple investigations and documentation tasks simultaneously.
• Effective communication skills, both written and verbal, to present findings and collaborate with stakeholders at different levels.
• Demonstrated ability to work independently while also contributing as a proactive member of a small quality team.

Work Environment

You will work as part of a small, collaborative quality team of approximately three other professionals in a hybrid work setting. During the initial phase of the contract, you will spend the majority of your time onsite to receive hands-on training, become familiar with the quality system, and integrate with cross-functional partners. After this training period, a hybrid arrangement with approximately two days in the office each week may be suitable, depending on project needs and performance. The environment is structured and regulated, with a strong emphasis on compliance, documentation accuracy, and adherence to FDA and ISO-based quality standards. You will use a Quality Management System (Qdocs) and other standard office and quality tools to manage investigations, documentation, and batch release activities, working closely with R&D, service, operations, and other stakeholders to support a robust and efficient quality system.

Job Type & Location

This is a Contract position based out of Golden, CO.

Pay and Benefits

The pay range for this position is $40.00 - $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 hybrid position in Golden,CO.

Application Deadline

This position is anticipated to close on Jul 31, 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.