Quality Engineer

Title: Quality Engineer

Location: Centennial United States

Job Description:

Systems & Software

55 USD - 55 USD/hour

Job Title: Quality EngineerJob Description

The Quality Engineer supports medical device development and manufacturing projects by ensuring compliance with regulatory requirements, quality standards, and internal procedures. This role focuses on building and maintaining robust quality systems, supporting design control activities, and driving continuous improvement initiatives to enhance product safety and effectiveness across the entire product lifecycle.

Responsibilities

• Develop, implement, and maintain quality systems in accordance with FDA QSMR requirements.
• Support design control activities, including risk management, verification and validation, and design transfer for medical device products.
• Conduct thorough root cause analysis and lead corrective and preventive actions (CAPA) to address quality issues.
• Collaborate closely with cross-functional teams such as R&D, Regulatory Affairs, Manufacturing, and Supply Chain to ensure quality is integrated throughout the product lifecycle.
• Review and approve validation protocols, reports, and test methods to confirm they meet regulatory and internal quality requirements.
• Ensure ongoing compliance with Good Manufacturing Practices (GMP) and applicable quality and regulatory standards.
• Support internal and external audits, inspections, and regulatory submissions by preparing documentation and participating in audit activities.
• Drive continuous improvement initiatives in quality processes and systems to enhance efficiency, compliance, and product performance.
• Manage nonconformance handling processes, including investigation, documentation, and implementation of corrective actions.
• Apply structured problem-solving tools, such as FMEA, 5-Why, and Fishbone diagrams, to identify and mitigate risks.

Essential Skills

• Bachelor’s degree in engineering, Life Sciences, or a related field.
• 3–5 years of experience in quality engineering within medical devices or other regulated industries.
• Strong knowledge of ISO standards, FDA QSMR requirements, and risk management standards applicable to medical devices.
• Hands-on experience with CAPA processes, nonconformance handling, and root cause analysis tools such as FMEA, 5-Why, and Fishbone diagrams.
• Familiarity with validation processes, including IQ, OQ, and PQ, and the use of statistical techniques in quality validation and analysis.
• Excellent communication skills, with the ability to clearly present quality issues and solutions to cross-functional teams.
• Strong documentation skills for preparing and maintaining quality records, protocols, reports, and regulatory documentation.
• Proven problem-solving abilities, with a structured and analytical approach to identifying issues and implementing effective solutions.
• Ability to work independently with minimal supervision while also collaborating effectively in cross-functional team environments.

Additional Skills & Qualifications

• Experience with software validation activities in a regulated environment.
• Familiarity with electronic quality management systems (eQMS).
• Knowledge of Six Sigma or Lean methodologies and their application to quality and process improvement.
• Prior involvement in new product development projects, particularly within medical devices or other regulated industries.
• Audit-related certification, such as ISO Lead Auditor, is a plus and supports participation in internal and external audits.

Work Environment

The role operates within a regulated medical device development and manufacturing environment that emphasizes compliance, documentation, and continuous improvement. You will work closely with cross-functional teams including R&D, Regulatory Affairs, Manufacturing, and Supply Chain, using quality systems aligned with FDA QSMR, GMP, and ISO standards. The position involves frequent interaction with validation activities, audits, and electronic quality management tools, with a focus on structured problem-solving and data-driven decision-making. Work hours typically follow standard business schedules, with occasional flexibility to support audits, inspections, or project milestones. Professional attire appropriate for office and regulated manufacturing or laboratory areas is expected, and you may spend time in both office and production or lab settings where adherence to safety and quality procedures is essential.

Job Type & Location

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

Pay and Benefits

The pay range for this position is $55.00 - $55.00/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 remote position.

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. 

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.