Quality Engineer

JOB DESCRIPTIONS DETAIL
NELIPAK

Function: QAQE - QUALITY ASSURANCE
Job: QUALITY ENGINEER

Job Description: Quality Engineer

Collaborates with customer and Nelipak engineering and product teams to establish material, process, and product quality standards, specifications, and manufacturing methods. Applies sound Quality Engineering principles to help ensure customer requirements are consistently met while maintaining compliance to ISO 13485 and other applicable Standards, Regulations, and Nelipak policies

Essential job duties and responsibilities include the following:

• Assist in the development and deployment of manufacturing processes, and changes to such processes.
• Prepare and oversee the execution of validation studies, including DOEs, IQs, OQs, PQs, and Test Method Validations.
• Develop, validate, and deploy sampling plans and test methods.
• Assist in the development and maintenance of Design and Process FMEAs.
• Oversee the evaluation and disposition of nonconforming materials and product.
• Lead the evaluation and resolution of quality-related product and production problems via the CAPA process.
• Spearhead recommendations for reducing actual or potential quality costs, especially costs of poor quality.
• Provide guidance to Quality Technicians, Supervisors, and Inspectors.
• Interfaces with customer representatives regarding quality issues and opportunities for improvement.
• Read and interpret engineering drawings and technical specifications.
• 1st article process that includes measurement, analyzing and report data.

Education and/or Experience:

• 5-7 years of quality engineering experience in a manufacturing environment, including design transfer, validation, and measurement analysis.
• BS in mechanical, materials, biomedical, or similar engineering.
• Quality Engineer (CQE) and/or Six Sigma Green/Black Belt certification(s) strongly preferred.
• Experience operating in ISO 9001, AS 9001, and/or ISO 13485 environments strongly preferred.
• Familiarity with ISO 14971 a plus.
• Thermoforming and/or medical packaging experience a plus.

Skills and Abilities:

• Proficient in MS Office, Minitab, AutoCAD, SolidWorks, etc.
• Proficient in statistical techniques for:

· Analysis of data

· Process characterization, development, and control (DOEs, SPC, etc.)

· Equipment, process, and test-method validation (IQ, OQ, PQ, TMV)

· Dimensional tolerancing and stacking

• Proficient in Risk Analysis techniques (ISO 14971 or similar)
• Excellent oral and written communication skills with customers and employees at all levels.
• Excellent organizational skills.

Job Type: Full-time

Pay: $70,000.00 - $90,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Experience:

• ISO 9001: 1 year (Preferred)

Work Location: In person