Quality Engineer

at  Best Sanitizers

WALTON, KY | FULL-TIME

Job Summary:
As one of the key members of the Quality group, the Quality Engineer will, with general supervision, own and lead projects from solicitation and proposal through design transfer for alcohol-based hand & surface sanitizers for Food Processing Janitorial Sanitation & Healthcare Industries. Responsible for assuring products conform to established requirements and standards through appropriate audit, inspection, validation and test activities. Directly supports Best Sanitizers, and interacts with many different functional departments, customers, suppliers, and internal and external experts to implement Quality goals.

Responsibilities:

• Contributes to the design and development of complex new products with an emphasis around ensuring design control (ISO 13485) and risk mitigation (ISO 14971) standards are met in line with company policies and procedures.
• Formulates procedures, specifications, and standards for products and processes.
• Participates in Team Meetings under Project Leader with cross-functional team.
• Determination and validation of inspection methods.
• Supports manufacturing and manufacturing engineering in the validation of suppliers and processes.
• Development of work instructions, device master records, test and inspection methods and visual standards.
• Reviews and approval of documents created within team.
• Identifies critical personnel, gauges, procedures, and materials needed for the qualification of new products.
• Creates production reports, manages supplier assessment and approved supplier lists (ASL) & creates audit plans.
• Manages the nonconformance process (customer, internal, supplier) which includes trend analysis, corrective and preventive actions for assigned products or product families.
• Ensures that suppliers have necessary information and facilities to deliver quality products meeting specifications.
• Manages quality aspects of projects, as required (timelines, prototypes, testing, suppliers, etc.).
• Contributes to cross-functional project teams to support all quality deliverables for design and development.
• Drives problem solving of product quality design and process related issues from product development through release and including quality-related product sustaining activities.

Requirements:

• 2-3 years of sit-down forklift experience preferred.
• 1-2 years of reach truck experience preferred.
• Hazmat experience preferred.
• Understand how to read pick tickets, issues sheets, and bill of lading
• Basic math and computer skills

EXPERIENCE:

• Continuous improvement: 1 year (Required)
• FDA regulations: 1 year (Required)
• Medical Device: 5 years (Required)
• chemical: 1 year (Required)
• CGMP: 1 year (Required)

EDUCATION:

• Bachelor’s Degree (preferred)

• Contributes to the design and development of complex new products with an emphasis around ensuring design control (ISO 13485) and risk mitigation (ISO 14971) standards are met in line with company policies and procedures.
• Formulates procedures, specifications, and standards for products and processes.
• Participates in Team Meetings under Project Leader with cross-functional team.
• Determination and validation of inspection methods.
• Supports manufacturing and manufacturing engineering in the validation of suppliers and processes.
• Development of work instructions, device master records, test and inspection methods and visual standards.
• Reviews and approval of documents created within team.
• Identifies critical personnel, gauges, procedures, and materials needed for the qualification of new products.
• Creates production reports, manages supplier assessment and approved supplier lists (ASL) & creates audit plans.
• Manages the nonconformance process (customer, internal, supplier) which includes trend analysis, corrective and preventive actions for assigned products or product families.
• Ensures that suppliers have necessary information and facilities to deliver quality products meeting specifications.
• Manages quality aspects of projects, as required (timelines, prototypes, testing, suppliers, etc.).
• Contributes to cross-functional project teams to support all quality deliverables for design and development.
• Drives problem solving of product quality design and process related issues from product development through release and including quality-related product sustaining activities