Quality Technician

Formed in 2000, Drive DeVilbiss has become a leading manufacturer of medical products with a strong and consistent track record of growth achieved both organically and through acquisitions. We are proud of our high-quality, diverse product portfolio, channel footprint, and global operating scale. Our products are sold into the homecare, long-term care, retail, and e-commerce channels in more than 80 countries around the world. Our mission is to enhance the quality of life of the people we touch.

About the role

The Quality Technician will conduct origination inspection of incoming parts and supplies used for manufacture of products and verify dimensional, visual, and/or functional requirements of internal machined product and/or processes. The Technician will ensure that all products conform to company standards and specifications.

Responsibilities

• Performs dimensional and visual inspections established by quality control plans.
• Records dimensional findings and maintains appropriate documentation.
• Ensures compliance to established inspection frequencies and AQL levels.
• Ensures all inspections are completed in a timely fashion.
• Reports any issues found with product quality to the Manager and/or Quality Engineer.
• Works with operators on a daily basis with part handling, ensuring products are packaged, handled, and moved according to established procedures.
• Ensures that all documentation and operations have been completed prior to movement to the next operation.
• Performs 1st article inspections.
• Documents non-conformances.
• Inspects products using gauges, coordinate measuring machine, scales, and visual inspection prior to shipment.
• Reconciles final inspection documentation for shipments.
• Reviews and interprets product and component drawings and supplier documentation.
• Performs tasks in accordance with applicable requirements of the FDA Quality System Regulation, ISO 13485, MDD, CMDCAS, and any other applicable regulations.
• Other duties and responsibilities may change at any time with or without notice.

Requirements

• Self-motivated with excellent organizational and time management skills.
• Technical background with the ability to read and interpret SolidWorks drawings.
• Working knowledge of domestic and international medical device regulatory requirements (FDA, ISO-13485, MDD 93/42/EEC, Health Canada regulations, etc.) preferred.
• Ability to frequently sit, stand, bend, or walk an entire shift.
• Frequently required to use hands to finger, handle, or feel objects.
• Ability to regularly lift and/or move up to 25 pounds repetitively.
• Work performed in a combination of manufacturing, warehouse, and office environments.
• Exposed to shop elements such as noise, dust, odors, fumes, and oils.

Qualifications

• Two-year degree in a technical field, or 5-7 years’ experience in Quality Assurance/Manufacturing.
• Experience with proper metrology practices (use of micrometers, calipers, height gauges, pin gauges) preferred.