Quality Assurance Technician

Zimmer Biomet; Louisville (KY); On-site; USD 52,000 - 76,000; Full time

Job summary

Zimmer Biomet in Louisville, KY is seeking a skilled QA Inspector to perform dimensional inspections on machined and molded components, ensure conformance to drawings, and generate QA records.

You will work with inspection devices like micrometers, calipers, optical comparators, and contribute to non-conformance reports and continuous quality improvements.

Applicants should have at least 5 years in a regulated manufacturing environment and be comfortable collaborating with cross-functional teams.

Qualifications

• High school diploma or GED required.
• Minimum 5 years relevant experience in ISO/regulatory environment.
• Experience in medical device manufacturing is a plus.

Responsibilities

• Perform dimensional inspections from engineering drawings, procedures, and external standards.
• Maintain inspection equipment including micrometers, calipers, optical comparator, concentricity gauge, and height & depth gauges.
• Generate Non-conformance Reports and coordinate disposition of products under investigation.
• Complete QA paperwork and generate inspection records and change requests as required.
• Collaborate with Manufacturing, Materials, and Engineering to improve overall product quality.

Skills

Dimensional inspection

Measurement devices

MS Office

Attention to detail

Education

High school diploma or GED

Tools

Micrometers

Calipers

Optical comparator

Gage blocks

Tensile testers

Job description

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.

What You Can Expect

• With direction from the QA Inspection Supervisor(s) and Quality Management perform dimensional inspections on machined and molded components manufactured from internal and external sources per engineering drawings and applicable external standards. Maintains inspection equipment including Vertex and Vectors. Also maintains control of products on hold.
• Perform first article and final product inspections working from engineering drawings, procedures, and external standards, using typical inspection equipment such as micrometers, thread gauges, calipers, optical comparator, concentricity gauge, and height & depth gages.
• Perform receiving inspection of Finished Goods and components using typical inspection equipment.
• Perform component testing utilizing various inspection equipment such as tensile testers, force gages and custom equipment.
• Complete and maintain all QA paperwork in accordance with established procedures and manufacturing practices including the generation of receiving and inspection records, first article reports, discrepant material reports, QA history log sheets, and document change requests (DCR’s) as required. Ensure all handwritten documentation is clear and legible.
• Support the qualification/validation of new products/process projects; perform specialized inspections to help engineering develop new products, gages, and inspection methods.
• Follow written procedures and engineering specifications utilized for inspection and ensure documents are kept current and adequate for the inspections performed. Provide feedback to QA Management on documents requiring updates or error correction.
• Interact with personnel from departments outside of the Quality Inspection department, i.e. Manufacturing, Materials, Engineering, etc, to improve on overall Quality of product entering into the QA Inspection department.
• Generate Non-conformance Reports for submitted product found out of specification. Coordinates movement/control/disposition of products that are under investigation for non- conformance. Coordinate shipment of Finished Goods scrap for destruction. Generate Quality Hold documents and coordinate containment of affected product.
• Publish various daily quality related reports.
• Perform additional duties as assigned by supervisor.
• Using typical MS Office software (Word, Excel, and Outlook) create and perform simple data entry tasks and procedure changes as requested by QA Management.

How You’ll Create Impact

• Perform first article and final product inspections working from engineering drawings, procedures, and external standards, using typical inspection equipment such as micrometers, thread gauges, calipers, optical comparator, concentricity gauge, and height & depth gages.
• Perform receiving inspection of Finished Goods and components using typical inspection equipment.
• Perform component testing utilizing various inspection equipment such as tensile testers, force gages and custom equipment.
• Complete and maintain all QA paperwork in accordance with established procedures and manufacturing practices including the generation of receiving and inspection records, first article reports, discrepant material reports, QA history log sheets, and document change requests (DCR’s) as required. Ensure all handwritten documentation is clear and legible.
• Support the qualification/validation of new products/process projects; perform specialized inspections to help engineering develop new products, gages, and inspection methods.
• Follow written procedures and engineering specifications utilized for inspection and ensure documents are kept current and adequate for the inspections performed. Provide feedback to QA Management on documents requiring updates or error correction.
• Interact with personnel from departments outside of the Quality Inspection department, i.e. Manufacturing, Materials, Engineering, etc, to improve on overall Quality of product entering into the QA Inspection department.
• Generate Non-conformance Reports for submitted product found out of specification. Coordinates movement/control/disposition of products that are under investigation for non- conformance. Coordinate shipment of Finished Goods scrap for destruction. Generate Quality Hold documents and coordinate containment of affected product.
• Publish various daily quality related reports.
• Perform additional duties as assigned by supervisor.Using typical MS Office software (Word, Excel, and Outlook) create and perform simple data entry tasks and procedure changes as requested by QA Management.

What Makes You Stand Out

• Ability to use typical measuring devices (micrometer, caliper, comparator, thread gages, go/nogo gages and custom gages) and test instruments (pull and torque testers).
• Experience in medical device manufacturing and / or clean room is a plus.
• Working knowledge of sampling techniques (e.g., ANSI Z1.4.), Good Manufacturing Practices and other regulatory standards required.
• Ability to read standard operating procedures engineering drawings; Ability to lift boxes less than 50 lbs
• Attention to detail
• Ability to work independently
• Good organizational and communication skills

Your Background

• High school Diploma or GED required.
• Minimum of 5 years applicable experience required.
• Work experience in an ISO and/or regulated industry environment preferred

Travel Expectations

None

EOE/M/F/Vet/Disability