Quality Engineer - Raynham, United States - Kaztronix

Kaztronix Raynham, United States

1 week ago

Description

Job DescriptionJob Description

Must Haves:
Minimum of B.S. In Engineering

5 + yrs. of experience in Med Device (Ortho preferred) environment as a Quality Enigneering and/or Validation rolepreferred in medical device company with active class III devices

Proficient at reading & interpreting technical drawings, CMM & dimensional inspection reports per ASME Y14.5M (GD&T)

Experience with dimensional data analysis utilizing software such as Excel and MiniTab

Provide statistical support, expertise and analytical problem solving for product development and manufacturing.

Ability to drive the development of product requirements, verification strategies, and validation strategies.

Proven experience in the practical application of statistical methods, data analysis, and reliability engineering

Proficient with the following software

MS Office (Excel, PowerPoint, Project)

MiniTab Statistical Analysis software

QA Compliance

Function as the QA representative to comply with all NPD compliance standards

Perform product and process internal audits and preparation for external audits as required

Ensure that project team are aware of and comply with relevant standards and processes

New product/process launch and/or transfer validation experience

From feasibility through full validation and commercial launch

Medical Experience with completing validations (IQ, OQ, PQ's, PVE, etc.)

Previously written, reviewed, and approved validation protocols and reports

Experience with quality items, procedures and documents:

Non-conformances

CAPA
PFMEA/DFMEA's

Gage R&R's

TMV's

Manufacturing Control Plans

Standard Operating Procedures (SOPs)

A thorough understanding of GMP/ISO regulations (ie: ISO 13485, ISO14971) and validation regulations

Experience with the use of root cause analysis and problem-solving tools such as A3 process, 5-whys, etc.
The ability to perform "hands on " troubleshooting and problem solving.

The ability to think on the feet and providing sound judgment.

The ability to collaborate with all levels of management in a cross-functional team environment.

Proven project management and project leadership abilities are required in addition to strong communication and interpersonal skills.

Nice to Have:
Experience with BOM's, Routes and ERP System Setup

Experience in leading Process/product validation projects

Creating and expediting trial and validation orders through production process

Working knowledge of Windchill, SAP, EtQ, MES

Yellow, Green or Black Belt Six Sigma

Ability to perform measurements utilizing CMM and hand tools (calipers, height gauges, dyer gauges, etc.)

CMM programing experience

Worked in a Casting or Forging Foundry

Related work experiences in any of the following areas

Injection Mold or Tools (designing, building, measuring, validating)

Investment, Sand, Die Casting or Foam Castings

Wax or Plastic Injection Molding

CNC Machining (of Castings a bonus)

Experience with the CNC Machining of

Investment, Sand or Die Castings

Forgings

Wrought/Bar Stock

or Plastics

Understanding of Lean Manufacturing

Experience with additive manufacturing (3D Printing)

Experience with Clean Line, Sterilization and Biocompatibility validations

Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements

Working knowledge and experience with FDA 21 CFR Part 820

Previous hands-on experience with working alongside trained technicians and operators

Participate and lead project team meetings to ensure actions and timelines were being met

Company DescriptionKaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

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