Sr. Quality Engineer

Posted 16 Days Ago
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Rutherford, NJ
Senior level
Other • Biotech
The Role
The Senior Quality Engineer will ensure products meet quality specifications by investigating quality issues, driving quality system improvements, and collaborating with design engineering and customer quality organizations. Responsibilities include leading quality initiatives, analyzing data, supporting operations troubleshooting, and maintaining regulatory compliance.
Summary Generated by Built In

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 around the globe, chances are, we have something special for you.

POSITION SUMMARY

The Senior Quality Engineer will provide quality assurance support to the product development team, resolving bugs, defects, and other potential issues and ensuring that products meet customer specifications.

ESSENTIAL DUTIES AND RESPONSIBILITIES

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, skills and or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Investigate product quality problems, determine root cause, gather, and analyze data and implement corrective action to reduce or eliminate cause. Drive quality system improvements and ensure compliance to regulatory and procedural requirements. Participate in the improvement of the manufacturing process for existing products. Review and approve work instructions, inspection documents, Bills of Material, and drawings.

  • Serve as a primary point of contact for quality related matters. Responsible for leading quality initiatives with operations and engineering to improve manufacturing processes and product quality.

  • Interface with customer’s engineering and quality organizations to efficiently address reported problems impacting functionality, quality, and regulatory requirements.

  • Work with design engineering to determine receiving inspection requirements of purchased components and finished product. Provide technical quality engineering support to receiving, in process and final inspection and testing.

  • Support operations in trouble-shooting non-conformities to confirm part defects.

  • Assist in development, review and approval of process and equipment validation/qualifications. Participate in external and internal regulatory compliance inspections and assist in Corrective Action System activities including evaluation of failure investigation and corrective action plans, root cause analysis and follow-up activities.

  • Ensure appropriate controls are defined, implemented, and satisfactorily completed for all appropriate operations. Collect, analyze, and track data across the Airtech manufacturing site related to entity quality and monitor key performance indicators by working with key partners.

  • Ensure accurate and timely processing of all Quality Records along with the company’s regulatory compliance profile per regulatory requirements.

  • Provide training to ensure proper implementation and use of quality tools and procedures as required.

  • Enable rapid and effective correction of quality/regulatory problems in a manner that prevents their reoccurrence. Review/approve nonconforming materials and associated documentation.

  • Review/approve product and process change control documentation and specifications.

  • Use quality tools & practices to establish approval criteria to ensure the identification of quality failure concerns for both internal and external manufactured parts and assemblies (e.g., FMEA (Failure Modes Effects Analysis).

  • Work closely with operations and quality to identify and resolve production and quality system deficiencies.

  • Lead investigations and analysis of customer returned product as well maintenance, repairs and overhaul requests

  • Performs other duties as assigned and within scope of work.

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, skills and or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Proficient with Microsoft Office Suite or related software.

  • Deep knowledge of quality assurance terminology, methods and tools

  • Demonstrated knowledge of testing best practices and defect management processes

  • Working experience with ISO 9001 Regulations preferred

  • Ability to work and perform in a team environment and effective interpersonal skills

  • Demonstrated high attention to detail

  • Excellent analytical decision making and problem-solving skills

  • Proven ability to resolve issues and participate in process improvement activities

  • Track record of successful business and customer orientation

  • Excellent written and verbal skills

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

  • Ability to effectively present information in one-on-one and small group situations

EDUCATION and/or EXPERIENCE

  • Bachelor’s degree in Engineering or related discipline required.

  • 5 plus years of related work experience

  • Experience with Root Cause Analysis, GD&T, measuring equipment, lean manufacturing preferred.

  • Prior experience with ISO 9001:2015

PHYSICAL DEMANDS: The physical demands described here are represented of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • While performing duties of the job, employee is required to move around and be still; use hands to handle objects, tools, or controls; reach with hands and arms; talk and hear.

  • Employee will occasionally lift up to 50 lbs.

  • Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.

WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Office and shop floor working environment.

  • Noise level is minimal with intervals of spikes.

  • Required to wear safety glasses and utilize safety equipment while present on the shop floor.

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).

Attention Applicants: 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 [email protected] for assistance with an accommodation. These contact tools may be used only by individuals with a disability for accommodation requests. Do not inquire as to the status of an application.

The Company
Northbrook, IL
2,112 Employees
On-site Workplace

What We Do

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.

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