Quality Technician

Drive Medical Canada; Lehigh Acres (FL); On-site; USD 29,756 - 34,440; Full time

Job summary

Drive DeVilbiss in Lehigh Acres, FL is seeking a Quality Technician to perform incoming part inspections and verify dimensional, visual, and functional requirements in manufacturing.

You will use gauges, CMM, and metrology tools, maintain documentation, and ensure compliance with FDA QSR, ISO 13485, and other regulations.

Two-year technical degree or 5-7 years QA/manufacturing experience preferred; ability to read SolidWorks drawings is required.

Qualifications

• Two-year technical degree or equivalent in a technical field.
• 5-7 years of QA/manufacturing experience preferred.
• Experience with metrology practices (micrometers, calipers, height gauges, pin gauges).

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 daily on part handling to ensure proper packaging and movement per procedures.
• Ensures documentation and operations are complete before moving to the next operation.
• Performs 1st article inspections.
• Documents non-conformances.
• Inspects products using gauges, CMM, scales, and visual inspection prior to shipment.
• Reconciles final inspection documentation for shipments.
• Reviews and interprets drawings and supplier documentation.
• Complies with FDA QSR, ISO 13485, MDD, CMDCAS and applicable regulations.

Skills

SolidWorks drawings

QA/manufacturing experience

Regulatory knowledge

Education

Two-year technical degree

Tools

Micrometers

Calipers

Height Gauges

Pin Gauges

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Quality Technician

Full Time Technical Lehigh Acres, FL, US

4 days ago Requisition ID: 3489

Salary Range: $21.60 To $25.00 Hourly

Who is Drive DeVilbiss...

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”

Your Mission:

The Quality Technician will be responsible toconduct origination inspection of incoming parts and supplies used for manufacture of partsand verifying 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.

Main Activities

• Performs dimensional and visual inspections established by quality control plans.
• Records dimensional findings and maintaining 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 with respect to critical components in assuring that products are packaged, handled and moved by established procedures.
• Ensures that all documentation and operations have been completed prior to movement to next operation.
• Performs 1 st 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

• Candidate must be self-motivated, have excellent organizational skills, time management skills and technical background.
• Must be able read and interpret solid works 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.

Your Education and Experience:

• Two years degree application based in Technical field, or
• 5-7 Years’ experience in Quality Assurance / Manufacturing experience
• Experience with proper metrology practices (use of Micrometers, Calipers, Height Gauges, Pin Gauges), preferred.