We have an immediate job opening for a Quality Engineer. The ideal candidate will have experience managing a Quality System, be familiar with FDA Medical Device Regulations (Title 21 CFR 820) and International Organization for Standardization (ISO 13485) requirements, be experienced in corresponding with FDA personnel, have a background in engineering and manufacturing, and possess management and leadership skills.

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As a condition of employment, you will be required to sign an Employment Agreement which includes a non-compete agreement, assignment of inventions agreement and a non-disclosure agreement. This offer is contingent upon the passing of a drug screen and clear background check.

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Schedule: This a full-time position, Monday through Friday during daytime hours. Onsite

Job Title: Quality Engineer

ESSENTIAL DUTIES:

Responsibilities including but not limited to:

• Design control management (verifications, validations, risk management, etc.)

• Complaint handling and failure investigation

• RMA failure trending

• Corrective and preventive action (CAPA) Management

• Design and model 3D components using Fusion 360.

• Reading and interpreting technical blueprints and design models

• Adjust machine settings to the desired product specifications, as needed

Preferred Qualifications/Skills:

• Bachelor of Science in Engineering (Mechanical preferred)

• Experience in quality and manufacturing

• Experience in Medical Device Regulations (ISO 13485 and FDA)

• Ability to write reports, business correspondence, and procedure manuals

• Excellent communication, organizational, and documentation skills

• Comfortable being a leader and taking initiative

• Ability to collaborate with Engineers

• Strong attention to detail

• Experience with Design Controls (design and development planning, change control, risk management)

• Ability to stand for extended periods

• Ability to walk throughout a manufacturing facility

• Must be a US Citizen (or currently permitted to work in the US)

Schedule:

• Monday to Friday 40 hours per/week

• Daytime

Salary

Forbes offers highly competitive compensation packages and pay will be determined based on qualification and previous experience.

Benefits

• Paid Time Off

• Holidays

• Vacation

Job Type: Full-time

Salary: $50,000.00 - $80,000.00 per year

Benefits:

• Paid time off

Schedule:

• Day shift

• Monday to Friday

Supplemental pay types:

• Bonus Pay

Job Type: Full-time

Salary: $50,000.00 - $80,000.00 per year

Benefits:

• Paid time off

Schedule:

• Day shift

• Monday to Friday

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• Mansfield, OH 44905: Reliably commute or planning to relocate before starting work (Required)

Work Location: One location

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Please email your resume and letter of interest to: careers@forbesaac.com