Senior Quality Engineer in Mahwah, New Jersey at Nobel Biocare

Date Posted: 5/13/2018

Job Snapshot

Job Description

Job ID: NOB002011

About Us

Nobel Biocare is a world leader in the field of innovative implant-based dental restorations – from single-tooth to fully edentulous indications. Nobel Biocare offers you a great place to work by giving you the opportunity to grow and be recognized for your effort and achievements.


The Senior Quality Assurance Engineer will provide production, in process & final quality control, process engineering, product development and administrative support of site Quality Assurance / Regulatory Compliance activities to assure compliance to internal and external requirements (21 CFR Part 820, cGMP & ISO 13485:2003) and other international regulatory bodies as applicable.      


  • Develop, implement and maintain Quality Assurance procedures (SOP’s) and policies in support of the Quality Management System for the site.

  • Authority to issue, review and approve documents in SAP with administrative oversight of the Document Management Process and Change Control. 

  • Administer and maintain the site CAPA process through the TrackWise application.  Prepare CAPA status reports at defined intervals.

  • Support In Process Control (IPC) & Outgoing Quality Control (OQC) through the application of statistical techniques.

  • Identify and implement continuous monitoring of production steps utilizing automated inspections systems and visual controls.

  • Establish OQC sample inspections of finished products at predetermined frequencies.

  • Develop process for Device History Record review and finished product release.

  • Implement a system of Inspection Plans and obsolete existing QC type SOP’s.

  • Assist QC Director in complaint investigations.

  • Train and educate the Procera organization in the Quality Management System. 

  • Report on a regular basis the status of the Quality Management System via analysis of quality data inputs from QA and other functions as appropriate.

  • Collect, organize, analyze, and provide data, information, and/or trend reports for management review in a format that clearly communicates the results.  Provide feedback data for Post Market Surveillance.

  • Serve as the alternate site Management Representative/Responsible Engineering Manager.

  • Participate in the planning and execution of periodic internal / external quality audits. 

  • Support regulatory inspections regarding quality systems.

  • Provide guidance and/or collaborate routinely with all functions (local & global) to ensure that quality system requirements are maintained and/or will be met.

  • Administer and maintain Master Validation/Verification list and facilitate periodic reviews per established procedures.

  • Assist in the administration of the calibration system through the Faciliworks application.

  • Guide all functions towards established quality objectives.

  • Support and oversight of proper level of documentation in projects leading to changes in production processes.  Includes participation in new product development teams for validation/verification planning & protocols, plan execution, inspection planning and review/approve associated documentation.

  • Support and oversight that new production equipment/processes have been tested and validated and/or verified before starting in regular production.

  • Serves as an alternate to Director of Quality Assurance as required.

  • Additional tasks/projects within QA as needed.

Job Requirements


Education / Skills:

  • Bachelor’s degree from a four-year College or University in an engineering discipline.

  • Four to six years of experience with FDA and international medical device regulations (i.e., 21 CFR Part 820, ISO 13485, MDD, JPAL and CMDR)

  • Must have good project management, communication and collaborative skills working individually or with various functional teams.

  • Ability to analyze trend data on quality systems metrics using standard statistical techniques such as Minitab.

  • Must be hands-on and able to multi-task to address existing and potential QA issues routinely.

  • Compliance certifications highly preferred.

  • Must have knowledge of basic computer software applications such as Microsoft Word, Excel, PowerPoint, etc. or equivalent.

  • Must be available to work on different rotations or hours depending on business demands.

  • Must be available to work in a flexible working environment and be willing to travel domestically or internationally depending on business needs.     

Nobel Biocare is an equal opportunity employer.  We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law. We maintain a drug-free workplace and perform pre-employment substance abuse testing.



Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and industrial solutions. Our globally diverse team of 59,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #144 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 2,000% over 20 years.

At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.