Quality Assurance Engineer I- CTQ

Job Title: Quality Assurance Engineer I - CTQJob Description

This is a hybrid role with a preference for local candidates. The position involves conducting quality complaint investigations for medical devices, ensuring compliance with industry standards and regulations.

Responsibilities

• Review and complete Quality Engineering complaint issue analysis tasks using various quality system inputs.

• Analyze data from quality inputs such as Field Corrective Action Complaints and FDA Medical Device Reports to determine trends and systemic issues.

• Prepare and issue reports based on information analysis.

• Review existing investigation reports, identify gaps for GMP compliance, and develop strategies to close these gaps.

• Develop and communicate expectations for quality performance, continuous improvement, and process controls.

• Monitor and drive corrective action and continuous improvement activities impacting performance measures.

• Conduct or lead corrective and preventive actions in manufacturing using formal problem-solving tools.

• Support CAPA and maintenance activities for existing product lines.

• Recommend and support projects for improvements to the quality system.

Essential Skills

• Medical Device Experience with knowledge of 21CFR820.

• Investigational research skills.

• Experience with statistical software packages, with Minitab being a plus.

• Knowledge of FDA cGMP, ANSI/ISO/ASQC requirements.

• Ability to read and understand blueprints and technical drawings.

• Strong analytical problem-solving and root cause investigation skills.

• Technical understanding of engineering principles and procedures.

• Proficiency in Word, Excel, PowerPoint, Minitab, Access, and databases.

• Ability to multi-task and methodically manage projects.

Additional Skills & Qualifications

• Bachelor of Science degree in Engineering.

• 1-3 years of experience in the medical device industry.

• Desired experience in the development and deployment of Quality Systems and process controls.

• Familiarity with continuous improvement methods.

Work Environment

The work environment is a manufacturing setting regulated by the FDA. Employees must adhere to safety protocols such as wearing a static protective smock and a ground wrist strap. The environment is temperature and humidity controlled and involves working in close proximity to other employees.

Job Type & Location

This is a Contract position based out of Skaneateles, NY.

Pay and Benefits

The pay range for this position is $30.00 - $33.00/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 Skaneateles,NY.

Application Deadline

This position is anticipated to close on Mar 10, 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 due to a disability, please email [email protected] (%[email protected]) for other accommodation options.