About Careertakes

👉 Important disclosure: Careertakes is a third-party recruiting platform supporting this hiring process. If selected, you will be employed directly by our client, Engineering.

Applicants for this role may also receive access to additional matched opportunities through the Careertakes platform.

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What You’ll Do

This Confidential Client is seeking a Quality Engineer to support new labeling processes and related manufacturing operations in an FDA‑regulated environment. You will help investigate quality events, document technical requirements, and partner with cross‑functional teams to ensure compliant, robust processes.

• Support quality and compliance activities related to new labeling processes and manufacturing operations.
• Lead and contribute to investigations, perform root cause analysis, and prepare clear investigation reports.
• Create, update, and maintain technical and regulatory documentation (e.g., DHF, validation records, quality records) consistent with design control and FDA requirements.
• Support validation planning and execution for new and existing processes; document protocols and acceptance criteria.
• Participate in risk management activities using FMEA and hazard analysis aligned with ISO‑related standards.
• Assist with internal and external audits: prepare documentation, respond to findings, and implement corrective/preventive actions (CAPA).
• Support change control and documentation updates to ensure proper approvals and implementation.
• Collaborate with manufacturing, engineering, and quality teams to drive continuous improvement and maintain a process‑oriented quality culture.

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Who You Are (Required Qualifications)

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or a related technical field.
• 0–2 years of relevant experience (including internships/co‑ops) in manufacturing, product development, or quality engineering within a regulated industry (medical device, biotech, pharmaceutical).
• Practical experience with root cause analysis and investigation writing; able to produce structured, logical reports.
• Strong technical writing skills for regulatory and quality documentation.
• Working knowledge of quality engineering principles and basic regulatory requirements in a regulated manufacturing setting.
• Attention to detail and strong organizational skills for accurate documentation and compliance work.
• Effective communicator with demonstrated ability to work cross‑functionally.

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Nice to Have (Preferred / Additional Skills)

• 2+ years performing root cause analysis and technical writing in bioscience-related sectors (medical devices, biotech, pharma).
• Familiarity with FDA regulations and design control documentation (DHF, validation records, quality system documentation).
• Hands‑on experience with FMEA and other risk‑management tools.
• Demonstrated interest in continuous improvement and process optimization in manufacturing environments.

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Work Environment & Schedule

• This role operates in an FDA‑regulated manufacturing environment with strong emphasis on documented processes and regulatory compliance.
• Typical schedule: Monday–Friday, first shift (approximately 7:00 a.m. to 3:30 p.m.).
• This is an onsite position; regular interaction with manufacturing and engineering teams is required.

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Compensation & Benefits

• Pay range (as provided): $65,000.00 - $80,000.00/hr. Individual compensation depends on qualifications, experience, geographic location, and other relevant factors. No salary has been fabricated — this range is from the source posting.
• Benefits (if eligible) may include:
  • Medical, dental & vision
  • Critical Illness, Accident, and Hospital coverage
  • 401(k) with pre‑tax and Roth options
  • Voluntary life & AD&D insurance
  • Short‑ and long‑term disability
  • Health Spending Account (HSA)
  • Transportation benefits
  • Employee Assistance Program
  • Time off (PTO, vacation, sick leave)

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Employment Type & Location

• Contract‑to‑Hire (initial contract with potential for direct hire).
• Workplace Type: Fully onsite.
• Location: Vandalia, OH (Vandalia, Ohio 45377).

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Equal Opportunity & Hiring Transparency

Careertakes and our client are Equal Opportunity Employers committed to building a diverse and inclusive workforce. We prohibit discrimination or harassment of any kind. To support a fair and efficient hiring process, AI tools may be used to assist with application review or resume screening. These tools do not replace human decision-making. Final hiring decisions are made by people.

If you have questions about how your data is used, please contact us directly.