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Date: May 20, 2018

Location: Franklin, Wisconsin, US, 53132

Company: Lubrizol Corporation

POSITION SUMMARY:

The Quality Engineer is primarily responsible for assuring product and Quality Systems quality and compliance through the development, implementation and monitoring of appropriate processes, tools, metrics and goals.  Specifically, the Quality Engineer position is the process owner for the site CAPA program, process validations, Customer Complaints, NCRs, CAPAs, Internal Audits, and assigned New Product Development programs.

 

DESCRIPTION OF ESSENTIAL DUTIES:

  • Supports new product development activities as directed through core team participation in the development of Master Validation Plans, PFMEA’s, Control Plans, Procedure and Process development
  • Supports investigation and resolution of NCRs and CAPAs.
  • Assist in other CAPA activities as directed, including complaint failure investigations and customer communications.
  • Owner of applicable Quality Systems related NCR/CAPA’s.
  • Role is subject matter expert and technical advisor on the CAPA element of the site quality management system.
  • Maintains current knowledge of ISO 13485 and FDA QSR requirements and applies to applicable Vesta processes.
  • Analyzes inspection and testing processes, mechanisms and equipment.
  • Develops and/or reviews product, process test equipment and/or software validation and qualification protocols and tracks execution of protocols in support of project timelines.
  • Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position.

 

DESCRIPTION OF MARGINAL DUTIES:

  • Observe and promote Company standards and policies on safety, quality and productivity.

 

DIRECT REPORTS: N/A

 

HIRING GUIDELINES: (To perform job successfully, and individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skills, and/or ability required/preferred).

  • Successful completion of four-years of high school, or equivalent, plus completion of four years of college with a bachelor’s degree, preferably in Biology or science arena.
  • Six to ten years experience in Medical Device Industry
  • Mastery knowledge of ISO 13485:2003, FDA 21 CFR Part 820 and Sterilization Principles
  • Experience with Statistical Process Control and Process Validation.
  • Certified Quality Engineer or Auditor (ASQ) (preferred)
  • Six Sigma Green or Black Belt (preferred)
  • Experience with Process, Product and/or Software Validation

 

 

 

OTHER GUIDELINES:

  • Technical writing skills applicable to the medical device industry or equivalent regulated industry.
  • Excellent (written and verbal) communication and effective human interaction skills.
  • Flexible to change, and possess a high degree level of integrity and “can do attitude”.
  • Willing to work in a team environment and contribute to group goals
  • Ability to receive and provide instructions in a positive manner.

 

PHYSICAL DEMANDS: (They physical demands described here are representatives of those that must be met by an employee to successfully perform the essential functions of the job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function.  The phrases “occasionally”, “frequently” and “constantly” correspond to the following definitions: “occasionally” means up to 33% of working time, “frequently” means between 34%-66% of working time, and “constantly” means 67% and more of working time.  Additionally vision requirement definitions are as follows: close vision-clear vision at 20 inches or less, distance vision—clear vision at 20 feet or more, color vision-ability to identify and distinguish colors, peripheral vision-ability to observe an area that can be seen up and down or to the left and right while eyes are fixed on a given point, depth perception-three-dimensional vision-ability to judge distances and spatial  relationships and ability to focus—ability to adjust the eye to bring an object into sharp focus ).

 

This physical demand level for this job is considered light with occasionally lifting 10-25 pounds.  Exposure to lifting more than 25 pounds is rare (if ever).

 

The employee may frequently be subject to dynamic standing/walking and using hands to finger or handle/touch with constant exposure to static standing/sitting.  The employee will rarely (if ever) be subject to pushing/pulling (rough poundage of force), floor to knuckle lift/lower, knuckle to shoulder lift/lower, shoulder to overhead lift/lower, sustained bending, use foot/feet to operate machine, climb or balance, stoop, kneel, crouch or crawl, reach above shoulders or repetitive bending or squatting.

 

The following vision requirements apply: close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

 

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

The employee will occasionally be exposed to working near moving mechanical parts.  The employee will rarely (if ever) be subject to wet humid conditions, working in high precarious places, fumes or airborne particles, toxic or caustic chemicals, outdoor weather conditions, extreme cold or heat, risk of electrical shock or travel on company business.  The noise level is considered moderate (business office, computer printer, light traffic level) and occasionally considered loud if near operating production equipment.

 

The employee will be required to wear appropriate Personal Protective Equipment such as: safety glasses in the designated areas, hairnet/beard net and jumpsuit when on production floor.

 

TOOLS/EQUIPMENT/COMPUTER SOFTWARE:

The employee will frequently use a PC with Microsoft Office products and occasionally use Minitab (or other statistical software), EQMS and MSA.

 

The above statements reflect the general details necessary to describe the principle functions of the occupation described and shall not be construed as a detailed description of all the work requirements that may be inherent in the occupation.

 


Nearest Major Market: Milwaukee

Job Segment: Quality Engineer, Engineer, CAPA, Electrical, Medical Device Engineer, Engineering, Management