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 compliance with FDA, ISO, and internal quality system requirements within a regulated medical device environment. This role partners closely with cross-functional teams to perform gap assessments, correct documentation, and provide guidance on CAPA processes and electronic quality management system (eQMS) usage, directly contributing to patient safety and product quality. Responsibilities Manage CAPA processes from initiation through investigation, action tracking, effectiveness verification, and closure. Support CAPA remediation by reviewing, updating, and correcting legacy CAPA records to meet current compliance standards. Perform detailed gap assessments of existing quality documentation and records, and implement updates to align with FDA, ISO, and internal quality system requirements. Ensure all CAPA-related activities comply with applicable FDA regulations, ISO standards, and internal quality system procedures. Partner with Quality, Regulatory, Operations, and Engineering teams to investigate issues, determine root causes, and define effective corrective and preventive actions. Conduct and document root cause analyses using structured problem-solving methods to identify and address underlying issues. Provide support and guidance to colleagues on CAPA processes, quality system expectations, and use of the eQMS or related quality management tools. Collaborate with cross-functional teams to integrate design controls, risk management, and FMEA outputs into CAPA activities and quality improvements. Contribute to supplier quality activities and audits by supporting investigations, documentation, and corrective actions as needed. Prepare, review, and maintain high-quality documentation to ensure accuracy, completeness, and regulatory compliance. Use statistical analysis and data-driven decision making to evaluate trends, assess CAPA effectiveness, and identify opportunities for continuous improvement. Support internal and external audit activities related to CAPA, quality systems, and regulatory compliance. Participate in cross-functional meetings and project teams to drive timely completion of CAPA actions and remediation projects. Essential Skills Demonstrated experience with CAPA management, including initiation, investigation, action tracking, and closure in a regulated environment. Strong root cause analysis skills and proficiency with structured problem-solving methodologies. Hands-on experience with medical devices or other regulated industries. Working knowledge of FDA quality system regulations and ISO-based quality systems. Experience with electronic quality management systems (eQMS) or similar platforms. Proficiency in performing gap assessments and updating documentation to meet compliance standards. Knowledge of ISO-based risk management principles and practices. Experience with design controls and failure modes and effects analysis (FMEA). Ability to apply statistical analysis and data-driven decision making to quality issues and CAPA effectiveness. Strong documentation and written communication skills with high attention to detail. Ability to collaborate effectively with Quality, Regulatory, Operations, and Engineering teams. Bachelor's degree in Engineering or a related field. Additional Skills & Qualifications Certified Quality Engineer (CQE) certification is preferred. Experience working within a quality management system for medical devices. Exposure to supplier quality activities and quality audits. Familiarity with innovative medical technologies and products. Comfort working in a documentation-heavy role with a focus on accuracy and compliance. Interest in contributing to patient outcomes and quality of life through improved product quality. Work Environment The role operates in a fast-paced, project-driven environment focused on CAPA remediation and continuous improvement within a regulated medical device setting. You will collaborate closely with Quality, Regulatory, Engineering, and Operations teams in a mix of independent work and team-based problem solving. The position involves significant documentation work with a strong emphasis on compliance, accuracy, and regulatory alignment. The work setting is office-based or hybrid, supporting a collaborative, cross-functional culture that offers hands-on experience with innovative products and advanced quality systems in the foot and ankle medical device space. 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 May 29, 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.