Job Opportunity - Quality Engineer

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.

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.

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

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