Lead, QA

Position Summary

The Quality Inspector Lead is designed to lead and coordinate the activities of the non-exempt personnel. The individual will oversee inspections, testing of sub-assemblies/final product, and control products that are on hold or that have been dispositioned. The individual supports manufacturing operations and engineering in the objective of producing a quality product in a timely, efficient and economical manner. The individual will need to demonstrate proficiency in and knowledge of statistical sampling techniques, measurement and functional test equipment, and medical device GMP regulations. This job requires the lead to write, implement and enforce standard operating procedures and safety rules.

Essential Duties & Responsibilities

• Proficient in reading, interpreting, and understanding drawings and specifications
• Assigning work to QA inspectors as required
• Ability to make decisions regarding product and involving engineering when needed
• Report and generate material non-conformance lot reports (NLR’s)
• Communicate quality issues with Production Engineering, Planning, and other departments as necessary within the organization
• Strong problem solving ability
• Train employees in Quality assurance procedures and assist management team in developing new cost improvement programs
• Follow cGMP
• Excellent organization skills
• Proficient at basic computer skills
Provide other job-related duties as assigned

Knowledge, Skills & Qualifications

• Strong knowledge of Plastic Processing
• cGMP knowledge
• Basic math skills
• Basic computer knowledge
• Strong written and verbal communication skills
• Familiarity with ASTM Standards a plus
• Familiarity with ISO 9001 and Medical Manufacturing Environments a plus
Must be detail oriented and follow instructions and specification meticulously

Education and Experience

• High School diploma or GED equivalent
• Minimum of 3 years in a Quality Assurance or development role
• Previous QA Lead experience preferred.
• Experience with ASTM Standards
• Experience with ISO 9001 and medical manufacturing environments
cGMP knowledge

Minimum Qualifications

Must be 18 years of age

Travel Requirements

Typically requires travel less than 5% of the time

Physical Requirements and Work Environment

• Work is performed in a clean room environment
• While performing the duties of this job, the employee may be required to sit or stand for long periods of time; depending on the machine they are operating
• Operator is required to use computer or touch screen to enter work order data

Must be able to occasionally move and lift objects of up to 30 lbs