Quality Engineer
Lubrizol is located in Franklin WI, a growing community of 35,000 people that is located in the Southeastern portion of Wisconsin, approximately 15 miles south of Milwaukee, WI and about 60 miles north of Chicago, Il.
The Southeastern portion of Wisconsin is bordered on the east by Lake Michigan, a Great Lake that has fantastic fishing and boating opportunities.
The City of Milwaukee is a diverse community with many ethnic festivals that occur almost every weekend from June until September.
Starting with the last week in June until the second weekend in July, the Henry Maier Festival Park, hosts Summerfest, one of the largest outdoor music festivals, highlighted by the Marcus Amphitheater, which hosts Main Stage concerts every evening.
Milwaukee is also the home to Harley Davidson, the Harley Museum and Harley Davidson Bike fest every 5 years.
If you are into professional sports, Milwaukee is home to the Milwaukee Brewers, who play at Miller Park, the Milwaukee Bucks who play at Fiserv Forum and the Green Bay Packers are within 2 hours driving distance from Milwaukee.
Lubrizol is an equal opportunity employer.
Qualified applicants will receive consideration for employment without regard to sex, race, color, national origin, citizenship, age, religion, marital status, military service, sexual orientation, genetic information, gender identity, or any other characteristic or trait protected by federal, state, or local law.
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.
The Quality Engineer is the process owner for the site CAPA program, process validations, Customer Complaints, NCRs, CAPAs, Internal Audits, and assigned New Product Development programs.
ESSENTIAL DUTIES &
Responsibilities:
- 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.
- Assists in other CAPA activities as directed, including complaint failure investigations and customer communications.
- Owns applicable Quality Systems related NCR/CAPA s.
- Maintains current knowledge of ISO 13485 and FDA QSR requirements and applies to applicable 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.
- Performs other duties as assigned.
SKILLS, EXPERIENCE, AND QUALIFICATIONS
- Minimum of Bachelor s degree, preferably in engineering or science-related field of study
- Excellent written and verbal communication skills
- Willing to work in a team environment and contribute to group goals
- Ability to receive and provide instructions in a positive manner.
Considered a plus:
- Knowledge of ISO 13485:
2003, FDA 21 CFR Part 820 - Previous experience in medical device or pharmaceutical industry
- Experience with Statistical Process Control and Process Validation
- Certified Quality Engineer or Auditor (ASQ)
- Six Sigma Green or Black Belt
- Experience with Process, Product and/or Software Validation
- Great technical writing skills applicable to the medical device industry or equivalent regulated industry
Lubrizol Franklin, part of Lubrizol Advanced Materials Health, offers custom medical manufacturing services, including precision thermoplastic and silicone extrusion fabrication from its ISO 13485 certified facilities.
Lubrizol Franklin capitalizes on more than 40 years experience, leveraging expertise in design assistance, material selection and quality compliance to enable our customer s success.
Lubrizol Franklin has served as a trusted medical device outsourcing partner for four decades, delivering innovative solutions in molding, extrusion and assembly.
Our Franklin, Wisconsin location includes ISO 7 certified clean room, ISO 8 controlled environment, 116,000 ft2 (10,700 m2), 17 extruders with 12 lines, 75 molding presses and a dedicated R&D laboratory.
Every one of our medical device manufacturing, assembly and support services has quality at its core.
Our highly collaborative, end-to-end, medical device process validation ensures quality without sacrificing product performance.
Estimated Salary: $20 to $28 per hour based on qualifications.
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