Quality Engineer in Middleton, Wisconsin at Orascoptic

Date Posted: 7/13/2018

Job Snapshot

Job Description

Job ID: ORA000256

About Us

Our purpose at Orascoptic is to assist clinicians in delivering better procedural outcomes through superior visualization. We do this by providing magnification with the best resolution, across the widest and through the deepest field of view.



Founded by a dentist in 1981, Orascoptic has been designing and manufacturing award-winning loupes and light systems in Middleton, Wisconsin for 30 years. Now a business unit within the Nobel Biocare platform of Danaher, we remain committed to establishing enduring customer relationships. Our goal is to have customers for life – from residency to retirement.


Description

The role of the Quality Engineer will be to keep up to date with Process and Software Validation regulatory requirements for medical devices, (FDA, HC, EU...), while leveraging the use of state-of-the-art inspection & Statistical methods and tools.  This position will administer the on-site Process, Software and Test Method Validation compliance programs.  The QE will also closely interact and support QA and provide hands-on troubleshooting expertise with in-house and supplier processes. 



ACCOUNTABILITIES:



  • Implements process, software and test method validation policy and procedures.  Writes protocols, facilitates completion of validation protocol procedures, performs data analysis, and writes reports.

  • Inter-company transfers of processes or in-sourcing activities.

  • Updates or changes to processes, software and test methods.

  • Introduction of new processes, new software, new test methods and new products.

  • Out-sourcing activities.

  • Maintains Process and Software Validation Master Plans.

  • Participates in product development teams and in design reviews.  

  • Conducts root cause and corrective action investigations for quality failures, including those occurring in supplier and internal processes.

  • Improves quality system by evaluation and improvement to inspection and test methods, sampling plans, and process control plans.  

  • Completion of the above duties and responsibilities will include the use of Gauge R&R Studies, Design of Experiments, Failure Mode and Effects Analysis, Statistical Process Control, Capability Studies, the determination of Operating Characteristics for Sampling Plans, and general statistical analysis of data.

  • Prepare and conduct training sessions and presentations as required to complete the above duties and responsibilities.

  • Plans and conducts the analysis, inspection, design, test, and/or integration to assure the quality of assigned product or component.

  • Performs quality engineering reviews of design documentation for compliance with stated requirements, including vendor quality manuals and company quality records.

  • Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes.

  • Reviews all purchased products or components and provides input to the decision of whether to accept the product and future purchases from the vendor.

  • Documents data obtained during all quality assurance activities, consistent with company policies and procedures.

  • Maintains a working knowledge of government and industry quality assurance codes and standards

  • Support, and when appropriate lead, CAPA’s creation and resolution.

  • Other duties as assigned.


Job Requirements



Qualifications

KNOWLEDGE, SKILLS & EXPERIENCE: 



  • 3-5 years of quality testing and experience in GMP quality processes in Medical Device production.

  • Measuring systems and analytics. 

  • Production systems, ERP knowledge a plus.

  • BS or BA Degree in Business, Engineering or Project Management required, Master’s Degree preferred.

  • Technical drawing reading.

  • Experience in lean manufacturing of Medical Devices.

  • Ability to accurately assess quality measurements and manufacturing operational metrics and situations and effectively address root cause and counter measure implementation.

  • Familiarity with various manufacturing process technologies.

  • Proficiency in project leadership and management.

  • Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.  

  • Ability to write routine reports and correspondence.  

  • Ability to speak effectively before groups of customers or employees of organization.

  • Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry.  

  • Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

  • Ability to define problems, collect data, establish facts, and draw valid conclusions. 

  • Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

  • To perform this job successfully, an individual should have knowledge of Spreadsheet software and Word Processing software.

CRITICAL SKILLS:



  • Project leadership

  • QMS expertise

  • Proven process improvement and change management skills.

  • Ability to apply lean manufacturing concepts and develop and install best practices across diverse business environments.

  • Ability to work and influence all levels of the organization from Senior Leaders, Functional Leaders to project managers and practitioners in all functional areas.

  • Ability to work with cross-functional teams globally.

  • Independence and good judgment, positive attitude, and an innovative spirit.

CRITICAL EXPERIENCE:



  • Manufacturing process 

  • Manufacturing quality systems

  • GMP general standards

  • CAPA leadership

  • ISO standards relating to Medical Device

  • Proficiency in continuous improvement

COMPETENCIES – Essential for the role:



  • High knowledge with measuring technology, production systems and quality systems.

  • ISO standards related to relevant Medical Device

  • Knowledge of GMP standards.

  • Teamwork - must be able to lead a team(s) of employees from multiple disciplines and/or companies.

  • Ability to influence others - must be able to inform, convince, and persuade others to action on key initiatives. 

  • Results orientation - must deliver results.

  • Technical excellence - must possess the technical skills necessary to effectively execute quality duties.

  • Communication - must be able to effectively communicate in both written and verbal forms, and at all levels in the organization.



Metrex Research Inc. 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.



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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 applied solutions. Our globally diverse team of 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% 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.