Lubrizol Quality Systems Manager in Franklin, Wisconsin

Quality Systems Manager

Req ID: 44967

Vesta, part of Lubrizol LifeSciences, offers custom medical manufacturing services, including precision thermoplastic and silicone extrusion as well as comprehensive silicone fabrication from its ISO 13485 certified facilities. Vesta capitalizes on more than 40 years’ experience, leveraging expertise in design assistance, material selection and quality compliance to enable our customer’s success.

Vesta 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.

POSITION SUMMARY:

The Quality System Manager manages thru subordinates the quality system that supports the manufacturing of medical devices. Responsible for maintaining, enhancing and implementing quality assurance programs to ensure continuous production of products consistent with FDA QSR and ISO 13485 requirements. Includes management of product complaints, documentation control (procedures, change management, product release, label control, documentation), software validation, internal and external audits, supplier quality, CAPA, and oversight of the product/process/equipment validation program, and adequacy of deviations and non-conformances related to process/product.

WHAT YOU WILL DO:

  • Management Representative for the facility regarding all Quality System issues.

  • Responsible for implementing and maintaining the Quality System for FDA and ISO requirements.

  • Manages all QA interaction with customers and outside agencies.

  • Evaluates Quality Systems and write, review, analyze, and revise written Standard Operating Procedures (SOPs) as needed in order to assure compliance to regulations

  • Lead ongoing daily departmental activities for areas of direct responsibility including supervision of assigned personnel

  • Manage and/or perform in-depth investigations and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude. Work closely with production supervisors, quality, engineering and other internal groups to accomplish company goals and influence necessary actions

  • Maintains appropriate quality metrics for trend analysis and reporting to local and divisional management.

  • Interfaces with inspectors/auditors during regulatory inspections and internal audits

  • Seeks new ways to improve and streamline current business and system processes. Identifies, manages, and leads multiple process/product improvement projects with the objective of achieving quality, efficiency and cost improvements

  • Other duties as assigned.

DIRECT REPORTS :

  • Quality Engineer(s)

  • Document Control Department

WHAT YOU NEED:

  • Bachelor’s degree preferably in the engineering or science fields.

  • Minimum 8 years of experience in medical device manufacturing, or any combination of education and experience that provides equivalent knowledge, skills and abilities.

  • Three to five years of demonstrated management and supervisory experience

  • Strong interpersonal, communication, influencing and negotiation skills. Must be able to work effectively and efficiently in a team environment.

  • Demonstrated in-depth knowledge of Change Control, Document Control, and CAPA systems in a cGMP environment

  • Experience with managing and developing quality systems, knowledge of Equipment/ Process Validation

  • Ability to supervise and direct employees, manage resources, establish development plans and conduct performance evaluations

  • Strong project management skills

  • Extensive Knowledge of ISO 13485 at mastery level and FDA 21 CFR Part 820

  • Certified Quality Manager (ASQ) (preferred)

  • Six Sigma Green or Black Belt (preferred)

  • Lean Manufacturing (preferred)

OTHER GUIDELINES:

  • Knowledge of advanced statistical concepts

  • Flexible to change, and possess a high degree level of integrity and “can do attitude”.

  • Ability to receive and provide instructions in a positive manner.

  • Passion to innovate and drive for solutions

Vesta 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 are building a new area 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.

Nearest Major Market: Milwaukee

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