Quality Engineer

Actalent is hiring for a Manufacturing Line Quality Engineer in Scarborough,MA!

Job Description

The Manufacturing Line Quality Engineer supports the Infectious Disease business unit by driving product quality assurance, improving quality processes, and ensuring compliance with all applicable quality system programs and regulatory requirements. This role works closely with production teams on the manufacturing floor to maintain high-quality standards, accurate documentation, and effective implementation of the Quality Management System.

Responsibilities

• Support production teams in resolving quality issues in accordance with established procedures and regulatory requirements.
• Provide on-the-floor support to manufacturing operations to ensure strict adherence to procedures and work instructions.
• Ensure accurate and complete Device History Record (DHR) documentation for all relevant manufacturing activities.
• Support line clearances, reworks, and inspections as required to maintain product quality and compliance.
• Demonstrate commitment to the development, implementation, and ongoing effectiveness of the Quality Management System in alignment with ISO, FDA, and other regulatory agency requirements.
• Exhibit professional behavior with internal and external business associates that reflects positively on the organization and aligns with company policies and practices.
• Maintain awareness of the quality consequences that may result from improper performance of job duties and act to prevent such issues.
• Understand potential device defects that may occur within the area of responsibility, including those related to product design, verification and validation, manufacturing processes, and testing activities.
• Collaborate with cross-functional teams to identify opportunities for quality process improvements and implement corrective and preventive actions.
• Perform other duties as assigned to support changing business needs and maintain operational flexibility.

Essential Skills

• Bachelor's degree in Engineering, Chemistry, Biotechnology, Life Science, or another technical field, or an equivalent combination of education and experience.
• Working knowledge of FDA current Good Manufacturing Practices (cGMPs), Quality System Regulation (QSR), and ISO quality system requirements.
• Strong technical writing skills with the ability to create clear, accurate, and compliant documentation.
• Effective verbal and written communication skills for collaboration with production and quality teams.
• Understanding of Good Manufacturing Practices (GMP) and current Good Manufacturing Practices (cGMP) in a regulated environment.
• Ability to work on a manufacturing floor and support real-time resolution of quality issues.
• Awareness of device defects and quality risks associated with product design, verification and validation, manufacturing, and testing activities.

Additional Skills & Qualifications

• Experience working within an FDA-regulated environment is highly beneficial.
• Familiarity with ISO-based Quality Management Systems and their implementation in manufacturing settings.
• Ability to interpret and apply quality standards and regulatory requirements to daily operations.
• Strong attention to detail and commitment to maintaining accurate quality records and documentation.
• Ability to collaborate effectively with cross-functional teams in a fast-paced production environment.

Work Environment

This is a 3rd shift role assigned to either C or D flight. C flight operates Sunday through Tuesday with alternating Wednesdays from 18:00 to 06:00, and D flight operates Thursday through Saturday with alternating Wednesdays from 18:00 to 06:00. The position is based on the manufacturing floor within an Infectious Disease production environment, requiring close interaction with production and quality personnel and adherence to established procedures and quality system requirements.

This is a Contract position based out of Scarborough, ME.

The pay range for this position is $37.00 - $40.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

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)

This is a fully onsite position in Scarborough,ME.

This position is anticipated to close on Oct 16, 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 View email address on click.appcast.io 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.