Senior Quality Engineer

Job Title:

Senior Quality Engineer Job Description The Senior Quality Engineer supports corrective and preventive action (CAPA) remediation by reviewing and updating legacy records, managing CAPA processes from initiation through closure, and ensuring documentation meets regulatory and internal compliance standards. This role partners closely with Quality, Regulatory, Operations, and Engineering teams to maintain robust quality systems in a regulated medical device environment. The position provides guidance on CAPA processes and electronic quality management system (eQMS) usage while driving data-driven improvements that directly impact patient outcomes and product quality. Responsibilities Review and update legacy CAPA records to support remediation efforts and ensure alignment with current quality system requirements. Manage CAPA processes from initiation through investigation, root cause analysis, action planning, implementation, tracking, effectiveness verification, and closure. Perform gap assessments on existing documentation and correct or update records to meet FDA, ISO, and internal quality system standards. Ensure compliance with applicable FDA regulations, ISO standards, and internal quality management system procedures across assigned projects. Partner with cross-functional teams, including Quality, Regulatory, Operations, and Engineering, to drive timely and effective CAPA execution. Provide subject matter guidance on CAPA processes, methodologies, and best practices to stakeholders across the organization. Support and guide users on the use of the electronic quality management system (eQMS) for CAPA and related quality processes. Conduct and document thorough root cause analyses for nonconformances, complaints, and other quality issues within the medical device environment. Contribute to risk management activities, including application of ISO-based risk management principles in CAPA and quality system activities. Support design controls and FMEA activities by integrating CAPA outcomes and risk mitigation actions into design and process documentation. Leverage statistical analysis and data-driven decision making to evaluate quality trends, identify systemic issues, and recommend improvements. Assist in preparation for and support of internal and external audits related to CAPA, quality systems, and regulatory compliance. Collaborate with supplier quality and other stakeholders to address supplier-related issues through structured CAPA and quality system processes. Maintain clear, accurate, and compliant documentation and communications related to investigations, assessments, and CAPA activities. Essential Skills Demonstrated experience managing CAPA processes in a medical device or regulated industry environment. Strong proficiency in root cause analysis techniques applied to quality issues and nonconformances. Hands-on experience with electronic quality management systems (eQMS) for CAPA and quality processes. Working knowledge of FDA quality system regulations and ISO-based quality systems. Experience performing gap assessments and updating documentation to meet compliance standards. Familiarity with ISO-based risk management practices, particularly as applied to medical devices. Experience with design controls and Failure Modes and Effects Analysis (FMEA). Ability to apply statistical analysis and data-driven decision-making in support of CAPA and quality improvements. Strong documentation and written communication skills with a focus on accuracy and compliance. Ability to collaborate effectively with Quality, Regulatory, Operations, Engineering, and other cross-functional partners. Experience in medical devices or other highly regulated industries. Bachelor's degree in Engineering or a related technical field. Additional Skills & Qualifications Certified Quality Engineer (CQE) certification preferred. Experience supporting supplier quality activities within a quality management system. Exposure to internal or external audits in a regulated environment. Experience working within a growing medtech or medical device organization. Comfort working with innovative products and advanced quality system tools. Strong interpersonal skills and the ability to influence cross-functional stakeholders. Work Environment The role operates in a fast-paced, project-driven environment focused on CAPA remediation within a regulated medical device setting. You will collaborate closely with Quality, Regulatory, Engineering, and Operations teams while balancing independent work with team-based problem-solving. The position involves a high volume of documentation with a strong emphasis on compliance, accuracy, and traceability. The work setting is office-based or hybrid, using electronic quality management systems and other digital tools to manage CAPA and quality activities. The culture emphasizes cross-functional collaboration, hands-on engagement with innovative foot and ankle medical device products, and a clear focus on improving patient outcomes and quality of life. Job Type & Location This is a Contract position based out of Englewood, CO. Pay and Benefits The pay range for this position is $35.00 - $45.00/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 Englewood,CO.

Application Deadline This position is anticipated to close on Jul 6, 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.