Quality Technician

Description

Job Overview:

This person will be responsible for performing visual, dimensional, and functional inspections of incoming materials including machined parts, injection molded parts, and printed circuit boards. They may perform routine returned goods analysis and disposition. They may also help with nonconformance and calibration processes, perform manufacturing process audits and Good Documentation Practice Reviews of manufacturing records, and functional testing of subassemblies and finished products.  

Responsibilities and Duties:

The primary responsibilities of this position are:

• Ensure that incoming materials conform to specifications and that documentation of materials, processes and secondary operations are correct.
• Verify and use proper tools and gages in a correct manner to perform inspections.
• Properly communicate inspection concerns, including test failures and unexpected data results. 
• Follow non-conformance procedures to quarantine and disposition materials as directed. 
• Collect, organize, and communicate data from various sources that will be used by internal quality, manufacturing, and R&D. 
• Work with Quality and Engineering team members to perform first article inspections (FAI).

The Quality Technician’s duties may also include the following:

• Help Quality team members ensure calibrated tools and equipment are properly tracked and maintained.
• Follow documented procedures in receiving, reviewing, and recording results for returned goods and customer complaints. 
• Work with Engineering to create and maintain Inspection Plans (IP’s) for new and existing materials.
• Assist Quality Engineering in addressing non-conformances.
• Perform Good Manufacturing Practice Audits of production areas and Good Documentation Practice Audits of production records. 
• Use test equipment and fixtures to test subassemblies and finished products as required.

Requirements

Education and Experience:

• Minimum 2 years’ experience in a regulated manufacturing environment – medical device industry experience preferred (GMP/QSR and ISO 13485)
• High School Degree required. College level coursework, with a technical background preferred, plus experience in a FDA regulated company. 
• Familiarity with roles in an effective manufacturing environment, including inspection, quality control, and production control. 
• Prior experience in using hand inspection tools and gages typically used in inspecting custom parts. 

Essential Knowledge and Skills:

• Ability to correctly interpret engineering drawings and part specifications.
• Commitment to understand and follow the procedural requirements of the company’s quality management system.
• Knowledgeable of good manufacturing practices (quality systems requirements)
• Proficient with Microsoft Office programs (e.g., Word, PowerPoint, etc.), particularly Excel.
• Excellent written and verbal communication skills.
• Able to multi-task, be flexible as priorities change, and work well with others.
• Must possess a high level of integrity, and attention to detail