Quality Assurance Technician Sr

Socket.dev; San Diego (CA); On-site; USD 75,000 - 85,000; Full time

Job summary

Zimmer Biomet seeks a Senior Quality Assurance Technician in San Diego to perform dimensional inspections on machined and molded parts per drawings and external standards. You will maintain inspection equipment and ensure QA records are complete and traceable.

Travel is minimal and collaboration with Manufacturing, Materials, and Engineering is expected. Required 3+ years in a regulated environment, high school diploma or GED, and proficiency with GDP and GDT concepts.

Qualifications

• High school Diploma or GED required.
• Minimum of 3 years applicable experience required.
• Work in an ISO and/or regulated environment strongly preferred.

Responsibilities

• Perform dimensional inspections on machined and molded components using inspection equipment.
• Maintain inspection equipment and QA paperwork according to procedures.
• Generate non-conformance reports and coordinate containment for non-conforming products.
• Create and maintain QA records and data for traceability.
• Interact with other departments to improve product quality entering QA.

Skills

Measurement devices

Dimensional inspection

GD&T understanding

MS Office proficiency

Quality reporting

Education

High school Diploma or GED

Tools

Keyence

CMM

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

We are looking to hire a Senior Quality Assurance Technician:

With direction from Quality Management perform dimensional inspections on machined and molded components manufactured per engineering drawings and applicable external standards. Maintains inspection equipment. Also maintains control of products on hold.

How You'll Create Impact

• Perform moderate to complex first article, on-line and final dimensional 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 inspections of raw materials and component parts using typical inspection equipment and custom equipment including programable inspection machines.
• Complete and maintain all QA paperwork in accordance with established procedures and manufacturing practices including the generation of first article reports, discrepant material reports and QA history log sheets.
• Execute dimensional, visual, functional, and attribute inspections required by approved validation protocols, engineering study plans, special inspection instructions, or other controlled inspection plans.
• Follow written procedures and raw material specifications utilized for inspection and ensure they are kept current and adequate for the inspections performed. Provide feedback to QA Management on documents requiring updates or error correction. Record raw inspection data contemporaneously and accurately in the approved protocol form, data sheet, or controlled electronic record without interpreting or changing acceptance criteria. Compile completed inspection records, instrument outputs, sample identification records, and other required objective evidence to support complete and traceable inspection documentation.
• 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, reducing rejections found and reported in QA.
• Generate Non-conformance Reports for submitted product found out of specification. May be required to complete portions of the Non-conformance Reports including sort/reprocess/rework instructions. Coordinates movement/control/disposition of products that are under investigation for non-conformance. 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) , test instruments (pull and torque testers).
• Proficiency in using dimensional and functional inspection equipment appropriate to assigned tasks (e.g. Keyence)
• Knowledge and experience with Good Documentation Practices (GDP) and accurate, complete, and traceable raw-data recording.
• Knowledge and experience in sample identification, traceability, segregation, and status control.
• Knowledge of calibration and verification requirements for inspection equipment and the ability to confirm equipment status prior to use.
• Working knowledge of sampling techniques (e.g., ANSI Z1.4.), Good Manufacturing Practices and other regulatory standards required.
• Ability to identify, document, and promptly escape deviations, unexpected results, equipment issues, and out-of-acceptance conditions.
• Ability to compile complete, accurate, and traceable inspection records and objective evidence with minimal direction.
• Ability to read standard operating procedures engineering drawings; solid understanding of engineering drawings utilizing Geometric Dimension and Tolerancing (GD&T) required.
• Ability to accurately complete technical reports with minimal direction.

Your Background

• High school Diploma or GED required.
• Minimum of 3 years applicable experience required.
• Work experience in an ISO and/or regulated industry environment strongly preferred.

Travel Expectations

As needed travel <5%

Salary Expectations: $75,000 - $85,000 USD

EOE/M/F/Vet/Disability