Quality Assurance Technician

Zimmer Biomet; Kentucky; On-site; USD 50,000 - 65,000; Full time

Job summary

Zimmer Biomet is seeking a QA Inspection professional to perform dimensional inspections on machined and molded components, utilizing micrometers, calipers, and optical comparators per engineering drawings and standards. You will maintain QA paperwork, generate reports, and support new product validation while collaborating with Manufacturing, Materials and Engineering teams.

Qualified candidates will have 5+ years in ISO/regulatory environments, experience in medical device manufacturing or

Qualifications

• High school diploma or GED required.
• 5+ years of applicable experience in ISO/regulatory environment preferred.
• Experience in medical device manufacturing and clean room is a plus.
• Ability to read SOPs and engineering drawings; lift boxes up to 50 lbs.

Responsibilities

• Perform dimensional inspections on machined and molded components per drawings and standards.
• Operate equipment like micrometers, calipers, optical comparators and gauges; maintain inspection records.
• Perform receiving inspections and component testing; generate QA documentation and reports.
• Support qualification/validation of new products and processes; provide feedback to documents.
• Interact with Manufacturing, Materials and Engineering to improve product quality.
• Publish daily quality related reports; perform additional duties as assigned.

Skills

Measurement devices

Medical device

Sampling techniques

SOPs & drawings

Attention to detail

Independence

Organization & communication

Education

High school diploma or GED

Tools

Micrometers

Thread gauges

Calipers

Optical comparator

Concentricity gauge

Height & depth gauges

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