Supplier Quality Engineer II
NORDSON MEDICAL CA LLC


Job Info


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 DUTIES & RESPONSIBILITIES

  • Follow all Quality System requirements and SOP's ensuring that regulatory requirements are met.
  • Conduct supplier approval activities including supplier audits and annual verification audits as scheduled by management.
  • Conduct part qualification including first article inspections and design verification testing as requested by customers or product engineering.
  • Certify supplier processes for critical parts by ensuring process control plans are adequate.
  • Conduct source inspection as required at suppliers.
  • Work with suppliers to manage and improve their performance based on performance metrics and direction from management.
  • Generate supplier corrective action requests as directed by management and ensure supplier responses are appropriate and evidence of completion is obtained in a timely manner.
  • Generate NMRs and RGAs as needed to manage nonconforming material.
  • Conduct and document failure investigations, root-cause analysis, and corrective/preventive actions for components and products as directed by management.
  • Participate in internal and external audit activities.
  • Generate protocols and reports as needed in support of engineering activities.
  • Participate on Product Development and Sustaining Engineering teams to facilitate supplier and manufacturing related issues.
  • Develop and validate inspection methodologies needed to assure quality of material.
  • Create and execute Gage R&R or Attribute Agreement studies to ensure alignment in measurement and inspection requirements.
  • Engage with Product Engineering on technical reviews and design reviews.
  • Supervise Quality Inspectors and Technicians on protocol execution and inspections.
  • Performs other duties as assigned by immediate supervisor.

EDUCATION & EXPERIENCE REQUIREMENTS
  • A basic working knowledge of ISO 13485:2003, QSR, ISO 14971:2007 and related standards
  • A Bachelor's degree in engineering or related discipline is required (Microbiology is highly valued). A Master's Degree in engineering or related discipline is preferred
  • Minimum 2-3 years experience working in a Regulated Industry (Aerospace, Automotive, Medical Device)


SKILLS & ABILITIES
  • Well developed written and verbal communication skills in English (Spanish highly valued). Ability to write and comprehend instructions, short correspondence, and memos. Ability to effectively present information to senior managers and other employees of the organization.
  • Ability to solve practical problems and deal with a variety of concrete variables and ability to interpret a variety of instructions furnished in written and oral form.
  • Ability to use measurement devices (vision system, caliper, micrometers, and variety of gages).


COMPUTER SKILLS:
  • Basic knowledge of Minitab, Microsoft Windows, Outlook, Word, Excel, Microsoft Project, etc. is required.
  • Ability to generate reports using data analysis, SPC analysis/tools, etc. and effectively communicate findings/proposals to various users in the organization


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.
  • While performing the duties of this job, the employee is regularly required to sit and use hands to finger, handle or feel, frequently required to talk or hear, occasionally required to stand, walk, reach with hands and arms, climb or balance, stoop, kneel and crouch.
  • Must be able to work in manufacturing environments exposed to moving mechanical parts and fumes or airborne particles.
  • The employee must occasionally lift and/or move up to 25 pounds.
  • Specific vision abilities required by this job include close vision.
  • The employee must be willing and able to travel to Mexico. This position requires at least 40% travel domestically and internationally.


TRAVEL REQUIRED

Estimated 25%

#LI-BS1
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.


This job has expired.

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