Quality Assurance Engineer

Tessy Plastics Corp.; City of Auburn (NY); Sur place; USD 80 000 - 100 000; Plein temps

Avantages offerts par ce poste

Health, dental & vision insurance

Profit-sharing program

401K match

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Statistical analysis

Statistical Process Control

Attention to detail

Quality systems knowledge

Advanced computer skills

Formation

Bachelor's degree in a relevant field

High Diploma or equivalent

Outils

Statistical software

Quality management tools

Description du poste

The Quality Assurance Engineer will support quality related issues within operations. They work collaboratively with the Quality team as well as members of the Production and Customer Service teams to ensure that all quality standards are met. Formulate lean six sigma practices to address continuous improvement in order to prevent nonconformance and ensure that end products meet and/or exceed customer specifications and company objectives are met.

What You'll Do

• Leads continuous improvement efforts within the manufacturing cell.
• Analyzes data to determine appropriate root cause and corrective actions needed.
• 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.

What You Bring

• Degree in relevant field of study or a High Diploma or equivalent and a minimum 5+ year’s related experience.
• Knowledge of quality systems, standards, and regulatory requirements (FDA/GMP preferred).
• Possess attention for detail with a high degree of accuracy.
• Advanced computer experience/ proficiency.
• Ability to read and interpret documents such as contracts, quality agreements, standards.
• Must apply Statistical, Graphical and practical understanding to carry out instructions furnished in written, oral, or diagram form.
• Ability to multitask and problem solve involving several variables in working situations.
• Proficient in use of statistical tools and have a strong understanding of Statistical Process Control methodology to the quality assurance process.
• Experience in injection molding, automation, or regulated industries preferred.

Salary Range: $80,000 - $100,000

The range displayed on each job posting reflects the minimum and maximum target base pay for new hire salaries of the position. This position may also be eligible for discretionary bonuses. Within the range, individual pay is determined by additional job-related factors, including knowledge, skills, experience, tenure and relevant education or training. The pay scale is subject to change depending on business needs. Your Recruiter can share more about the specific salary range or benefits during the hiring process.

• Health, Dental & Vision Insurance: 100% employer-paid for employee-only coverage, +1 and Family coverage options available.
• Additional Incentives: Quarterly profit-sharing program.
• 401K Company match.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

Tessy Plastics Corp. is an equal opportunity employer. Tessy evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.