Senior Quality Engineer

Thoroughly experienced and proficient degreed-engineer that provides technical solutions to a wide range of difficult problems.  Their solutions are imaginative, thorough, practical, and consistent with project or strategic objectives.  They will lead projects which have a clear scope and project path and they are trusted to interact directly with the customer.  They work under general direction and independently determine and develop approaches to solutions and their work is reviewed upon completion for adequacy in meeting objectives.  Failure to complete their projects would have significant impact and cause delay and would likely require additional resources.  Senior Quality Engineers may use advance techniques such as Design of Experiments (DOE) and may be asked to provide statistical justifications in their work.

ESSENTIAL DUTIES & RESPONSIBILITIES

• Provides technical support to Manufacturing and Product Engineering regarding validations, test method validations, and statistical analysis.
• Supports the planning, development, implementation and maintenance of manufacturing methods, processes and operations for new and existing products as well as the design and manufacturing of new tooling and equipment.
• May conduct evaluation, approval and performance monitoring of suppliers.
• Manages the identification, segregation, and disposition of nonconforming material and processes.
• Provides sustaining Engineering support to resolve manufacturing issues in the plant.
• Participate in lean and cost reduction activities.
• Conducts investigations and associated actions related to CAPA and Internal/external audit activities.
• Conducts investigations and associated actions related to customer complaints.
• Performs Internal audits as needed.
• May support execution/hosting of external audits.
• Supports maintenance of Quality System implementation with procedure and form maintenance and development.
• Provides training as subject matter expert, where recognized as such.

EDUCATION & EXPERIENCE REQUIREMENTS

Bachelor’s Degree in Engineering from an engineering/technology accredited program, graduate degree a plus

5-10 years’ directly related experience, preferably in medical device

SKILLS & ABILITIES

MS Office suite & Project

Minitab

FMEA

ISO 14971

GMP

Controlled environment per ISO 14644-X

Knowledge of ISO13485 requirements

Lean & Six sigma tools such as DMAIC or PDCA

Metrology & ISO 17025 Requirements

MSA

Blueprint reading and/or GD&T

FDA 21CFR:820 Requirements

QMS Auditor 

WORKING CONDITIONS & 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 10%

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.