Hybrid Quality Engineer chez Tedia

Quality Engineer 

 We are seeking a highly skilled and motivated Quality Engineer to join our team in the manufacturing industry at our Fairfield, Ohio location.   We are a customer-driven company that provides high-purity solvents for life science, biotechnology, pharmaceutical, laboratory, and industrial applications.  We are in need of a strong contributor to help us stay focused on two of our core values and they are:   Safety and Quality.  

As a Quality Engineer, you will be responsible for maintaining the Quality Management System (QMS) in conjunction with site compliance. Primary responsibility is to monitor, address, support and enhance the site’s product quality and ensure that all products are made within requirements. Secondary responsibility is to serve as a subject matter expert in a focus area assigned by the Quality Manager. 

Tedia wants you to have everything you need to work in a safe, fun and productive environment so we are pleased to offer: 

• Competitive compensation allows for annual salary increases based on the environment and work performance along with generous vacation and sick time which includes 9 paid holidays and a matched 401(k) retirement plan!  
• Competitive health care benefits that include health, dental, vision, life insurance, along with a variety of voluntary benefits, i.e., short term & long-term disability, critical illness and legal shield, etc. 
• Career growth and development i.e., education reimbursement, coaching, mentorships, and training programs. 
• Reward and recognition celebrations i.e., free monthly luncheons, monthly birthday celebrations, and service awards.

 Core Responsibilities: 

• Daily site quality record review and associated inspections for product release. 
• Records include but are not limited to production batch records, process forms, quality test records, and SAP reconciliation. 
• Inspections include but are not limited to visual inspection on the production floor and warehouse spaces of processes, materials and products. 
• Support internal and external customers and the Quality Department by managing QMS functions in a timely manner. Functions include but are not limited to:
• Investigation and CAPA support, execution, and review. 
• Change Management coordination, initiation, execution, editing and review.
• Supplier Management coordination, execution, and review. 
• Training coordination and onboarding for site quality expectations.
• Label generation and review. 
• Serve as subject matter expert in focus area assigned as a quarterly rotation by the Quality Manager. Focus areas are:
• Continuous Improvement, Validation and Verification
• Supplier Management, Qualification and Scorecard
• Investigations, Root Cause Analysis and CAPA Effectiveness
• Serve as a Quality representative in both internal and external discussions related to product quality and site compliance. 
• Internal Audit coordination, execution, and review.
• External Audit coordination, hosting, and response.
• Perform risk assessment decision making for Quality.
• Perform other duties as assigned 

Qualifications:

• Understanding and utilization of QA methodologies and standards
• Proficiency in reading and understanding various technical documents such as blueprints, material specification sheets, etc.
• Ability to effectively communicate technical concepts, problems, and ideas to various levels within the organization 

Education Requirements: 

REQUIRED:  

• Associate’s degree in Scientific field.
• Minimum of 2 years’ experience in a Quality role.
• Minimum of 2 years’ experience in a manufacturing environment.
• Minimum of 2 years’ experience in technical writing.

 PREFERRED: 

• Bachelor’s Degree in Scientific field. 
• Metric generation and data analysis experience. 
• Project management experience.
• Validation experience.

 Employment Type:  Full-time 

Industry:  Manufacturing - Quality

Work Environment /Physical Demands:  
  This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers and filing cabinets. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. 

• May occasionally lift and/or move up to 25 pounds. 
• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.