Quality Engineer

Quality EngineerThe Quality Engineer supports quality and compliance activities for new labeling processes and related manufacturing operations in a highly regulated, FDA-governed environment. This role focuses on investigations and root cause analysis, technical documentation aligned with design control requirements, and collaboration with cross-functional teams to ensure products and processes meet regulatory and quality standards throughout the product lifecycle.ResponsibilitiesSupport quality and compliance work tied to new labeling processes, including conducting investigations, performing root cause analysis, and working cross-functionally to identify, resolve, and prevent 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 partner with manufacturing and engineering teams across the product lifecycle to ensure robust quality controls and continuous improvement.Assist with risk management activities using tools such as Failure Modes and Effects Analysis (FMEA) and hazard analysis in accordance with ISO-related standards.Support validation efforts for new and existing processes, helping to define requirements, execute validation activities, and document results in compliance with regulatory expectations.Maintain and improve quality system procedures and documentation, ensuring they remain current, compliant, and effective in supporting operations.Assist with internal and external audits and other compliance activities by preparing documentation, responding to findings, and supporting corrective and preventive actions.Help drive change management by supporting documentation updates, coordinating approvals, and assisting with implementation of changes in a regulated manufacturing environment.Collaborate with cross-functional stakeholders, including manufacturing, engineering, and quality teams, to promote a process-oriented, quality-focused culture.Essential SkillsBachelor's degree in Biomedical Engineering, Mechanical Engineering, or a related technical 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 device or pharmaceutical.Hands-on experience with root cause analysis methods and investigation writing, including the ability to structure clear, logical reports.Strong technical writing skills for creating and maintaining quality and regulatory documentation.Understanding of quality engineering principles and practices in a regulated environment.Ability to work effectively in complex, highly regulated manufacturing settings and follow established processes and procedures.Attention to detail and accuracy in documentation, analysis, and compliance-related activities.Ability to collaborate cross-functionally and communicate clearly with engineering, manufacturing, and quality teams.Additional Skills & Qualifications2+ years of experience performing root cause analysis and technical writing within a bioscience-related industry such as medical devices, biotechnology, or pharmaceuticals.Familiarity with FDA regulations and design control requirements, including documentation such as DHF, validation records, and quality system documentation.Experience with risk management tools such as FMEA and hazard analysis, ideally aligned with ISO-related standards.Background or coursework in biomedical engineering, mechanical engineering, or closely related disciplines with a focus on regulated product development.Demonstrated process-oriented mindset and interest in continuous improvement within manufacturing and quality systems.Work EnvironmentThis role operates in an FDA-regulated manufacturing environment that emphasizes adherence to quality systems, documentation standards, and regulatory compliance. The position follows a Monday through Friday, first-shift schedule, typically from 7:00 a.m. to 3:30 p.m., providing a structured workday within a production and engineering setting. The environment involves close collaboration with manufacturing and engineering teams, use of standard office and production documentation tools, and consistent engagement with established procedures and validation protocols.Job Type & LocationThis is a Contract to Hire position based out of Vandalia, OH.Pay and BenefitsThe pay range for this position is $65000.00 - $80000.00/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)Workplace TypeThis is a fully onsite position in Vandalia, OH.Application DeadlineThis position is anticipated to close on Sep 4, 2026.