Reports To
Director of Quality Assurance and Regulatory Compliance
SCOPE OF THE ROLE
The Quality Engineer owns the creative problem-solving processes that ensure the consistency and precision of the products that we manufacture. Using a root cause mentality and technical knowledge, this person unearths the underlying causality for NCMRs, CAPAs, and customer complaints, and developing efficient solutions to create more consistently compliant products. The QE is an integral part of the organization, leading, collaborating, facilitating and supporting the needs of the organization. With the support of others, the Quality Engineer champions our customer retention and keeps the operation’s Quality Control above par in a high-volume, 24-hour environment.
Knowledge, Skills & Required Abilities
- Develop and maintain detailed guidelines for Quality and production personnel to follow, ensuring adherence to precise product standards
- Work with Operations and Engineering to increase efficiency through the improvement of in-house and supplier manufacturing processes, and product quality/reliability.
- Lead components of the Quality Management System such as Review Boards, CAPAs, Non-conforming Materials, Return Goods, and customer complaints, fostering a quality culture that strives for continuous improvement and customer satisfaction.
- Drive continuous improvement projects based on KPI’s identified during review of the QMS such as RMA and NCMR reductions.
- Analyze effectiveness and follow-up on corrective actions put in place in Quality/production processes
- Perform receiving, first article, in-process and final inspections on a variety of raw materials, molded components, work in process, and finished assemblies using precision analog and electrical measuring equipment in a statistic-based approach.
- Support the qualification of new parts/materials, and machine validation through FAI/capability analysis, or equivalent
- Coordinate with management, general labor and outside inspection agencies to ensure compliance to site Quality standards, including participation in Material Review Board (MRB) discussions
- Perform data analysis, interpret, and present results to management, customers and vendors with a high degree of technical details and writing.
Qualifications
Perform other duties as required QUALIFICATIONS
- 5+ years of Quality Control experience in a manufacturing environment; or equivalent combination of education and experience
- Bachelor of Science in Mechanical or Industrial Engineering, or equivalent
- In depth experience with ISO9001:2015 and ISO 13485:2016
- Expert in common inspection techniques, including the use of hand tools (micrometer, caliper, height gage, etc.)
- Expert with measurement and test equipment (MT&E) including programming of automated CMM and vision system equipment
- Excellent troubleshooting skills with Root Cause Analysis mentality
- High degree of knowledge using Excel for data analysis and presentation of results
- In-depth knowledge of data trending using a statistical based approach
- Significant attention to detail
- Approaches Work with Safety First Principles
PREFERRED QUALIFICATIONS:
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- Experience in ISO13485:2016 manufacturing or similarly regulated environment
- Experience working in cleanroom environment
- Experience with JDE
- Advanced and in-depth knowledge of Geometric Dimensioning & Tolerancing (GD&T)
- Excellent verbal and written communication skills
IDEX HEALTH & SCIENCE, LLC
IDEX Health & Science is the global leader in life science fluidics, microfluidics, and optics, offering a three-fold advantage to customers by bringing optofluidic paths to life with strategic partnerships, solutions, and expertise. As one of the few companies in the world with component, sub-system, and application level experts, IDEX Health & Science helps instrument developers solve the most demanding fluidic and optical challenges in a wide array of applications. With over 1,200 employees around the world, we believe partnership will change the way the world innovates, leading to new technologies that improve our health, protect our planet, and enrich our lives. For more information visit: www.idex-hs.com
FLUIDICS AND MICROFLUIDICS TEAMS
Our fluidics team is located across Oak Harbor, WA, Rohnert Park, CA, Bristol, CT, and Middleboro, MA. At IDEX Health & Science, we don’t just build components; we also create innovative solutions that maximize performance and enable complete optimization of the fluidic pathway. Product lines include: Column Hardware, Degassers, Fluidic Connections, Manifolds, Pumps, Pump Components, Sensors, RI Detectors, and Valves.
Our microfluidics team is in Middleboro, MA and Zweibrücken, Germany. As the number one provider of microfluidic consumables across the globe, we are ready to help you solve the next big thing with the broadest portfolio of capabilities. Product lines include: Microfluidic Consumables, Sample-to-Answer Solutions, Supporting Labware.
About Idex Corporation
IDEX Corporation, based in Northbrook, Illinois (suburb of Chicago), is a $2.2 billion engineered solutions company. The company operates globally across a variety of markets, including: Agriculture, Analytical Instrumentation, Food and Beverage, Chemical Processing, Clinical Diagnostics, Custom Precision Dispensing, Fire & Rescue, Fuels & Energy, Medical, Sanitary, Semiconductor and Water.
These businesses comprise a strong platform for growth at IDEX. Chairman & CEO, Eric Ashleman, is committed to strategic (organic and acquisitive) growth across the business. With a strong balance sheet, IDEX is in a very good position to make strategic acquisitions going forward. At the same time, IDEX is committed to finding value and has no interest in overpriced acquisitions for the sake of top line growth alone. As the company continues to evolve and grow, it will be an exciting and rewarding environment for the strategic, results-oriented and emotionally intelligent business leader.
Disclaimer
The information on this job description has been designed to indicate the general nature and level of work performed by employees within this role at the Middleboro facility of IDEX Health & Science. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. This document does not create an employment contract, implied or otherwise, other than an “at will” employment relationship.
IDEX Health & Science LLC., a Unit of IDEX Corporation is an Equal Opportunity Employer committed to workforce diversity.
Are you ready to join a different kind of company where our people, our culture, and our commitments are centered around providing trusted solutions that improve lives around the world?
IDEX is an Equal Opportunity Employer and Affirmative Action Employer. IDEX gives consideration for employment to qualified applicants without regard to race, color, religion, creed, genetic information, sex, sexual orientation, gender identity or expression, marital status, age, national origin, disability, protected veteran status, or any other consideration or protected category made unlawful by federal, state or local laws (Minorities/Females/Protected Veterans/Disabled).
Posted 24 Days Ago Full time R-01139
IDEX (NYSE: IEX) is a company that has undoubtedly touched your life in some way. In fact, IDEX businesses make thousands of products that are mission-critical components in everyday activities. Chances are the car you’re driving has a BAND-IT® clamp holding your side airbag safely in place. If you were ever in a car accident, a Hurst Jaws of Life® rescue tool may have saved your life. If you or a family member is battling cancer, your doctor may have tested your DNA in a quest to find the best targeted medicine for you. It’s likely your DNA test was run on equipment that contains components made by our growing IDEX Health & Science team.
