Quality Engineer

  • Upper Saddle River, NJ
  • Full-time

Company Description

Triangle Manufacturing Company, Inc. has been a leader in contract manufacturing for over 50 years, working with many of the foremost medical and commercial OEMs in the world. Development expertise, precision machining to the tightest tolerances and meticulous finishing and assembly are our hallmarks. We have three state-of-the-art facilities, dedicated to medical instruments, surgical implants and commercial industry.

Job Description

Join our team as a Quality Engineer!

Triangle Manufacturing Company, Inc. has been a leader in contract manufacturing for over 50 years, working with many of the foremost medical and commercial OEMs in the world. Development expertise, precision machining to the tightest tolerances and meticulous finishing and assembly are our hallmarks. We have three state-of-the-art facilities, dedicated to medical instruments, surgical implants and commercial industry.

Located in Upper Saddle River, NJ Triangle offers a clean, safe and progressive environment. We are registered to ISO 9001:2008 & ISO 13485:2003.

 

SUMMARY 

As a corporate resource to the manufacturing groups, the Quality Engineer provides support with quality and production activities as required, ensuring a high level of quality production and adherence to the Quality Management System, all applicable regulations and customer requirements as well as lean manufacturing principles by performing the following duties. 

 

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

  • Develops standards and methods for inspection, testing, evaluation and calibration as well as formulates and maintains quality control objectives to maximize product reliability and minimize costs.
  • Evaluates and audits suppliers on a regular basis in collaboration with company buyers.
  • Supports manufacturing engineers in their execution of dynamic control plans (DCP) to control product characteristics and process variability, and qualification and validation programs (IQ, OQ, PQ) to verify all equipment and instruments related to the process (as required by customer).
  • Plans, creates and troubleshoots CMM programs, creates Inspection Sheets (IP), selects and procures appropriate gages, and provides and/or updates documentation as needed. 
  • Tests and inspects items at various stages of the production process to determine if items meet specifications. 
  • Works closely with internal departments to resolve in-house and supplier quality problems using established problem-solving methodologies. Investigates root cause of customer and/or supplier rejections and internal quality failures, dispositions non-conforming parts, recommends and implements effective corrective action as required and provides accurate and timely responses to customers. 
  • Troubleshoots production and/or quality issues on the production floor and provides appropriate technical assistance to operators, in addition to identifying and implementing process improvements. 
  • Audits and supports operators to ensure compliance with inspection frequencies, documentation requirements and process controls. 
  • Provides training in basic and advanced measuring techniques, including the use of the CMM, Comparator, and other measuring equipment, to improve competency levels throughout the manufacturing groups.
  • Supports the implementation of lean manufacturing principles and tools to improve productivity and eliminate waste. 
  • As a company internal auditor, conducts audits in compliance with quality system requirements and provides accurate and timely reports. 
  • As an active participant of the Quality Team, monitors the performance and effectiveness of the Quality Management System through appropriate measurements, customer feedback, audit findings, etc., and recommends corrective or preventive actions as required.
  • Leads and/or supports CAPA investigations and related corrective and preventive actions.
  • Understands and complies with company policies, safety guidelines, quality system procedures and housekeeping standards.

Qualifications

QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

  •  Bachelor's degree in an engineering discipline from four-year college or university is required
     
  • A minimum of 5 years’ experience as a Quality Engineer in the medical device or automotive industry
     
  • Demonstrated knowledge of advanced quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, SPC, and Root Cause Analysis.
     
  • Extensive knowledge of FDA 21CFR820 & 11 and ISO 13485
     
  • Experience in the usage of inspection equipment, including calipers and pull testers
     
  • Ability to read and interpret blueprints
     
  • Strong knowledge of CMM programming concepts and applications, and experience in design and use of gages and measurement equipment is required
     
  • CQE certification and Six Sigma Green or Black Belt are highly preferred

Additional Information

All your information will be kept confidential according to EEO guidelines.