Quality Assurance & Process Improvement Engineer

Tessy Plastics Corp.; City of Auburn (NY); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Health, dental & vision insurance

Profit-sharing program

401K match

Job summary

Tessy Plastics Corp. in Auburn, NY, seeks a Quality Assurance Engineer to support quality issues across operations and collaborate with Quality, Production, and Customer Service teams.

The role focuses on lean six sigma practices to prevent nonconformance and ensure products meet customer specs and company objectives. The successful candidate will lead continuous improvement within manufacturing cells, perform data analysis for root cause and CAPA, support audits, and participate in validation

Qualifications

• Degree in a relevant field or an equivalent high diploma.
• Minimum 5+ years of related experience.
• Knowledge of FDA/GMP regulations preferred.
• Detail-oriented with high accuracy.
• Proficient in reading and interpreting contracts and quality documents.

Responsibilities

• Leads continuous improvement within the manufacturing cell.
• Analyzes data to determine root cause and corrective actions.
• Supports audits (Regulatory or Customer) interface within the assigned customer or manufacturing cell.
• Lead root cause investigations and implement corrective & preventive actions (CAPA).
• Support validation activities, including IQ/OQ/PQ, as required.
• Develop strategies and use tools to manage multiple customer specific projects to meet key metrics of on time delivery and overall product quality.
• Verifies that all appropriate instructions are in place to meet customer, FDA and/or other outside agencies requirements.

Skills

Statistical analysis

Statistical Process Control

Attention to detail

Quality systems knowledge

Advanced computer skills

Education

Bachelor's degree in a relevant field

High Diploma or equivalent

Tools

Statistical software

Quality management tools

Job description

Tessy Plastics Corp. in Auburn, NY, seeks a Quality Assurance Engineer to support quality issues across operations and collaborate with Quality, Production, and Customer Service teams.

The role focuses on lean six sigma practices to prevent nonconformance and ensure products meet customer specs and company objectives. The successful candidate will lead continuous improvement within manufacturing cells, perform data analysis for root cause and CAPA, support audits, and participate in validation