IDEX Quality Engineer-Design Assurance in West Henrietta, New York
If you’re looking for a special place to build or grow your career, you’ve found it. Whether you’re an experienced professional, a recent college graduate or somewhere in between, IDEX is a place where you can apply your existing skills and learn new ones in an environment where you can make an impact.
With interesting opportunities in engineering, marketing, sales, supply chain, operations, HR, finance, and more across more than 40 diverse businesses (https://www.idexcorp.com/our-businesses/business-segments/) around the globe, chances are, we have something special for you.
JOB TITLE: Quality Engineer – Design Assurance Engineer / Senior Engineer
REPORTS TO: Director of Quality Assurance
SITE LOCATION: Center of Excellence, West Henrietta, NY
These positions may require lawful access to ITAR/EAR controlled information and employees in this role will need to meet those requirements. Requirements include US Citizenship or US Permanent Resident.
Who is IDEX Corporation?
IDEX (NYSE: IEX) is a leading global manufacturer of diversified products in industries ranging across health, science, safety, fire, and fluidics. Operating in 24 countries, IDEX is an innovative and growing company, focused on delivering excellence through diverse, winning teams. We’re a global provider of applied solutions serving a variety of markets. These include life science and medical technologies, process industry and infrastructure related applications, industrial/municipal fire, and rescue - to name just a few.
Who is IDEX Health & Science (IH&S)?
As a business unit of IDEX Corporation, IH&S has a long history of driving growth in life sciences and healthcare by embracing innovation and redefining the supplier-customer relationship. The work we do every day allows us to discover key insights and break new ground to create some of the most meaningful technologies that have a lasting impact on companies, industries, and society. One of business segments is called Life Science Optics and we are looking to add more talent to the team.
Life Science Optics (LSO):
Our newly opened Optics Center of Excellence in West Henrietta, NY , is a manufacturing and R&D focused team that sits at the leading edge of high-end optics for life sciences. Focused on assisting partners at every stage of the development processes, we invest in people and infrastructure to drive bold ideas and pragmatic solutions. With its optical-rich foundation of talent, universities, and supporting businesses, Rochester is the ideal location to elevate your career with fascinating work and endless opportunities.
Our formula for success is simple. We work hard to maintain a culture where you can own your work; you are encouraged to try new ideas in a collaborative environment; and you can apply your skillset to enable our clients to gain a competitive advantage in their own market. At IDEX Health & Science, you have the opportunity to work with a great group of people, mentor others, and build a great future.
SCOPE OF ROLE:
The primary responsibility of this position is to ensure that IH&S products meet purchase specification, design and quality/reliability requirements. This position will serve as a direct interface with our suppliers and customer quality assurance functions in support of failure investigations, corrective actions and operational readiness reviews. It is critical for this person to be a team player, positive and collaborative, as required to contribute to the success and growth of IH&S. The QE is an integral part of the organization, leading, collaborating, facilitating and supporting the needs of the organization with a sense of ownership and integrity fostering a positive work environment and a shared Quality Culture.
Lead NPI quality planning activities in support of the Product Development Process
Participate in the creation of initial and annual regulatory reports to CDRH.
Participate in Material Review Board activities and feedback to suppliers
Support change management activities to satisfy internal and/or external customer requirements.
Assist in the development and management of qualification plans (IQ, OQ, PQ) to ensure process, equipment, design, and supplier changes are appropriately evaluated, and validated.
Administer internal audits and corrective action activities in compliance with QMS procedures and ISO standards.
Manage Gauge R&R and capability studies to ensure repeatability of processes.
Partner with manufacturing engineering to implement and manage effective process control and improvement activities through the monitoring of metrics.
Generate routine QMS reports and key metrics in support of daily management activities.
Revise internal procedures as applicable to implement a comprehensive customer and supplier quality management program.
Ability to travel approximately 20% both domestic and international.
Bachelor’s degree in engineering or related technical degree.
Minimum of 5 + years Quality Engineering / Manufacturing Engineering experience.
Experience with Geometric Dimensioning and Tolerancing techniques
In depth experience with ISO9001:2015 and/or ISO13485:2016
Prior experience within a manufacturing operation is required, ideal candidate will have Laser / Optic Manufacturing experience.
Familiar with mechanical inspection tools and/or CMM experience
Familiar with modern quality tools such as FMEA, Control Plan and Statistical techniques
Advanced communication skills in English – both written and oral
Demonstrated advanced proficiency with Microsoft Office (i.e. Word, Excel, Outlook, PowerPoint)
ASQ Certification, Certified Quality Engineer, or equivalent certification
Six Sigma Green or Black Belt Certification
Experience utilizing the JD Edwards software
Experience with project management
Knowledge of REACH/ROHS regulations to support compliance and issuance of Declarations of Conformity.
Knowledge of FDA CDRH reporting is a plus
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, please let us know. Likewise, if you are limited in the ability to access or use this online application process and need an alternative method for applying, we will determine an alternate way for you to apply. Please contact our Talent Acquisition Team at firstname.lastname@example.org .
IDEX Health & Science LLC., a Unit of IDEX Corporation is an Equal Opportunity Employer committed to workforce diversity
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.
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 (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.