Quality/Ehs Engineer

Nordson Corporation Easton , PA 18042

Posted 4 weeks ago

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

  • Assure compliance with FDA Quality System Regulation, ISO Standards and SOP's as defined by Nordson's policies, practices, and procedures.

  • Apply Quality Engineering techniques on new and existing products. Assure all products meet or exceed customer requirements.

  • Support product teams in the implementation of Lean/Cost Saving Initiatives.

  • Represent Quality in production process efforts, quality planning, FMEA and Risk Analysis.

  • Participate in IQ/OQ/PQ validation activities including the drafting, review, and execution of protocols.

  • Apply statistical tools such as Process Capability, Measurement System Analysis and Statistical Process Control to assess and improve production processes.

  • Handle customer complaints including the implementation of problem-solving actions to ensure product quality. Maintain all required documentation for closure.

  • Support the QC Department in the proper documentation and disposition of non-conforming product.

  • Work with departments to assure thorough Corrective Action problem solving implementation.

  • Review product and process changes to ensure proper documentation and actions related to risk assessment are complete.

  • Train Quality Assurance Inspectors and manufacturing personnel in understanding specifications, new product, procedures and measurement techniques.

  • Lead or participate in internal/external Quality System audits.

  • Maintain effective working relations, communications and feedback with all other departments.

  • EH&S Responsibilities, as assigned, including

Lead Zero Incident Safety Culture

Facilitate risk assessment to identify and mitigate critical EHS hazards

Ensure compliance with OSHA and all local regulations

Partner with CI Team and Operations to drive EH&S- and Quality-focused NBS Next activities for the facility

Education and Experience Requirements

  • BS in Engineering or Engineering Technology

  • 5 years' experience in 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

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 25%

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.

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.

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Quality/Ehs Engineer

Nordson Corporation