Continuous Improvement Quality Engineer Ii

Collaboration drives Nordson's success as a market leader in Industrial Precision Solutions and Advanced Technology. Our employees thrive in an environment where we help each other reach our personal best and enable our company to continuously improve and grow, and our customers to succeed. You will find Nordson employees sharing our success by giving back in the communities around the world where we live and work.
Nordson MEDICAL designs, engineers and manufactures complex devices and components with applications in wound healing, surgical and minimally invasive, fluid management, pulmonology and interventional and structural heart. Our pioneering Advanced Polymers team was the first to manufacture and supply medical balloons to the medical device industry. Nordson MEDICAL works with doctors, start-ups and large medical companies around the world at any point in the product lifecycle, from concept to launch and beyond.
Essential Job Duties and Responsibilities
* Ensure compliance with FDA Quality Management System Regulation, ISO Standards, and SOP's as defined by Nordson's policies and procedures.
* Apply Quality Engineering techniques to new and existing products and processes. Ensure all products meet or exceed customer requirements.
* Select and lead internal projects to meet company quality and financial objectives.
* Apply statistical tools such as Process Capability, Measurement System Analysis and Statistical Process Control to assess and improve production processes.
* Implement key customer quality strategies, such as FTQ and CCP.
* Select and lead projects to reduce reliance on verification, move from product sampling to process measurement, and achieve parametric release.
* Drive improvement in measurement technology and the introduction of automated measurement for both products and processes.
* Work with departments to ensure thorough investigations and problem solving to achieve effectively implemented corrective action.
* Review product and process changes to ensure proper documentation and actions related to risk assessment are complete.
* Represent technical quality in internal/external Quality System audits, inspections.
* Develop strong relationships with key customer Quality partners.
* Implement NBS Next foundational attributes.
Education and Experience Requirements
* BS in Engineering, Engineering Technology, or related field
* 5 years' experience in Quality and Medical Device Manufacturing
* 21 CFR 820 and/or ISO 13485 QMS experience
* ASQ CQE preferred
* Fluently read, write, and speak English
Skills and Abilities
* Statistical techniques as applied to medical device manufacturing
* Product and process development
* Risk management
* Root Cause investigation
* Lean and 6 sigma tools
* Metrology planning
* IMT
* Control plan development
* Product and process improvement
* Personnel development and leadership
Working Conditions and Physical Demands
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Travel Required
Estimated 30%
Nordson Corporation provides equal employment opportunity to all applicants and employees. No person is to be discriminated against in any aspect of the employment relationship due to race, religion, color, sex, age, national origin, ancestry, disability, sexual orientation, gender identity, genetic information, citizenship status, marital status, pregnancy, veteran status or any other status protected by applicable federal, state, or local law. All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check, consistent with applicable laws.Third party recruiters and agencies should not contact employees of Nordson or its subsidiaries directly. Any resumes sent to a hiring manager or submitted to Nordson employees are considered unsolicited and property of Nordson. Nordson will not pay a placement fee unless the agency or recruiter has a signed contract with Nordson's Human Resources department in advance of submitting a candidate for consideration. Verbal and written approvals will not be considered a valid contract for service.