Quality Engineer - FDA Regulated Environment

Quality Engineer

This stable, fully-staffed quality team is ADDING a Quality Engineer to oversee quality in a specific area of the manufacturing plant. The Quality Engineer will report to the Quality Manager and will be responsible for the following tasks:

• Maintain, monitor and improve quality standards in an assigned area of the manufacturing plant
• Lead root cause analysis and corrective actions for quality issues related to production, supplier and customer concerns
• Utilize formal problem solving to resolve quality issues
• Investigate customer and supplier quality issues
• Evaluate, develop and improve plant KPIs and metrics and complete monthly reporting related to the metrics
• Complete validation related to IQ (instrument qualification), OQ (operation qualification) and PQ (performance qualification)
• Complete supplier audits as needed
• Work with engineering and production to resolve quality issues
• Complete all quality documentation and ensure thoroughness in the process
• Follow GMP standards on a daily basis
• Other tasks as assigned by management

Candidates must be able to communicate directly and effectively at all levels, be team oriented and self-motivated, take initiative on projects, have excellent investigative and analytical skills and enjoy being hands on in the process. This position will spend up to 50% of the time on the manufacturing floor. This position requires minimal travel. Medical benefits are available day one of employment.

Other benefits include holiday, vacation, 401K, profit sharing and bonus potential.

Requirements for the Quality Engineer:

1. Minimum of a Bachelor’s degree; a technical field is preferred 2. At least 3-5 years in a similar manufacturing quality role
3. Experience working in FDA/GMP regulated environments, including food, food packaging, beverage, feed, pharmaceutical, etc. 4. A strong background with root cause analysis and corrective actions
5. Working knowledge of HACCP
6. Experience with validation, including IQ, OQ and PQ 7. Minitab
8. Microsoft Word, Excel, PowerPoint and Outlook

Skills preferred but NOT required:

1. SPC charting
2. Auditing 3. 5

WHY and/or fishbone diagrams
4. Lean and/or Six Sigma certifications

Why work for this organization:

1. Company supplies multiple industries; diverse business mix 2. EXCELLENT benefits, including 401K, profit sharing and bonus potential 3. No layoffs in the last 23 years
4. Good work/life balance
5. This is a newly created position due to growth
6. Fast-paced work environment

Candidates are preferred to be local to the Fremont, Ohio area.