Quality Engineer

Job Title:

Quality Engineer

Job Description

This role supports quality and compliance activities for new labeling processes within an FDA-regulated manufacturing environment. The Quality Engineer investigates issues, performs root cause analysis, and collaborates with cross-functional teams to resolve problems and maintain compliance. The position contributes to technical documentation, risk management, validation, and quality planning across the product lifecycle, ensuring that processes and records align with regulatory and design control requirements.

Responsibilities

* Support quality and compliance work related to new labeling processes, including conducting investigations, performing root cause analysis, and partnering with cross-functional teams to resolve issues.

* Create, update, and maintain technical documentation in alignment with FDA and design control requirements, including Design History Files (DHF), validation documentation, and quality records.

* Contribute to quality planning activities and collaborate with manufacturing and engineering teams throughout the product lifecycle to ensure consistent quality and regulatory compliance.

* Assist with risk management activities using tools such as Failure Modes and Effects Analysis (FMEA) and hazard analysis in accordance with applicable ISO standards.

* Support validation efforts for new and existing processes to confirm they meet defined requirements and regulatory expectations.

* Maintain and improve quality system procedures and documentation, ensuring records remain current, complete, and compliant.

* Assist with internal and external audits and other compliance activities by providing documentation, clarifications, and support as needed.

* Help drive change management by supporting documentation updates, coordinating approvals, and assisting with implementation of changes in a regulated environment.

Essential Skills

* Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or a related engineering field.

* 0-2 years of experience, including internships or co-op roles, in manufacturing, product development, or quality engineering within a regulated industry such as medical devices or pharmaceuticals.

* Hands-on experience with root cause analysis methods and investigation writing in a regulated environment.

* Strong technical writing skills with the ability to produce clear, accurate, and compliant documentation.

* Experience working within an FDA-regulated environment or similar highly regulated setting.

* Demonstrated ability to operate in a process-oriented manner and navigate complex manufacturing environments.

* Foundational knowledge of quality engineering principles and practices.

* Ability to collaborate effectively with cross-functional teams, including manufacturing and engineering.

Additional

Skills & Qualifications

* 2+ years of experience performing root cause analysis and technical writing within a bioscience-related industry is highly desirable.

* Experience with risk management tools such as FMEA and hazard analysis aligned with ISO standards.

* Exposure to design control documentation, including Design History Files and validation documentation.

* Familiarity with maintaining quality system procedures and supporting audits and compliance activities.

* Experience supporting change management processes in a regulated environment.

Work Environment

This position operates within an FDA-regulated manufacturing environment that emphasizes strict adherence to quality and compliance standards. The role follows a Monday through Friday schedule on the first shift, typically from 7:00 a.m. to 3:30 p.m. The work involves close collaboration with manufacturing, engineering, and quality teams, with a strong focus on documentation, process discipline, and regulatory compliance. Employees work in a structured setting where procedures, validation activities, and quality records play a central role in daily operations.

Job Type & Location

This is a Contract to Hire position based out of Vandalia, OH.

Pay and Benefits

The pay range for this position is $65000.00 - $80000.00/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 Vandalia,OH.

Final date to receive applications

This position is anticipated to close on Jun 3, 2026.

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