Quality Systems Project Manager - Medical Device Job at Lubrizol Corporation, Brecksville, OH

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  • Lubrizol Corporation
  • Brecksville, OH

Job Description

Job Title: Quality Systems Project Manager - Medical Device

Job Location:  Remote

Job type: Full-time

Type of role: Remote/Hybrid (40-50% travel required)

 

About Lubrizol

The Lubrizol Corporation, a Berkshire Hathaway company, is a specialty chemical company whose science delivers sustainable solutions to advance mobility, improve wellbeing and enhance modern life. Founded in 1928, Lubrizol owns and operates more than 100 manufacturing facilities, sales, and technical offices around the world and has about 8,000 employees. For more information, visit .

We value diversity in professional backgrounds and life experiences. By enabling a consistent, unbiased, and transparent recruitment process, Lubrizol seeks to create a positive experience for candidates so we can get to know them at their best. We recognize unique work and life situations and offer flexibility, ensuring our employees feel engaged and fulfilled in every aspect of life.

Join Our Thriving Team at Lubrizol as a Quality Systems Project Manager - Medical Device

Unleash Your Potential. At Lubrizol we're transforming the medical device market and looking for exceptional talent to join us on this journey. If you are ready to join an international company with talent around the world, and want to make a real impact, we want you on our team.

 

What You'll Do:

Quality is a critical element of the Lubrizol Vision and a long-term customer commitment. Our mission is to reliably deliver products that consistently meet our customers’ quality expectations. The Quality Assurance Systems Project Manager Medical Device is accountable for developing and governing quality assurance policies, systems and processes for LZAM medical contract manufacturing sites. Working with the commercial, manufacturing, and quality control (QC) teams, this role will establish quality assurance policies, systems and processes that are designed to prevent instances of product defects, while improving productivity, standardizing and modernize quality control. This role interacts with internal stakeholders, customers, and external organizations and agencies to align the quality goals and activities of the business with the applicable product and manufacturing quality standards. 

 

What We're Looking For:

  • Develop, and integrate with the greater Lubrizol enterprise, standard quality policies, processes, and systems
  • New software integration support (ERP, eQMS, MES)
  • Supplier Auditing and liaison with Supply Chain/Procurement
  • Customer complaint management, corrective/preventive action planning, and internal nonconformance investigation support
  • Production facility audit readiness support and Internal Auditing
  • KPI creation and management
  • Lubrizol standard work rollout support
  • Medical device business growth support

 

Skills That Make a Difference:

  • Bachelor Degree or higher in a scientific or regulatory field
  • Minimum of 5 years experience operating within FDA compliant quality management system
  • Demonstrated success negotiating with and successfully managing audits with customers and government agencies
  • Strong communication and presentation skills with demonstrated ability to present to and successfully advocate for institutional change
  • Strong analytical and problem solving skills 
  • Comfortable with and able to influence senior leadership
  • Experience with defining, implementing and operating ERP, digital QMS, digital manufacturing and batch execution systems is preferred

 

Perks and Rewards That Inspire:

  • Competitive salary with performance-based bonus plans
  • 401K Match plus Age Weighted Defined Contribution
  • Competitive medical, dental & vision offerings
  • Health Savings Account
  • Paid Holidays, Vacation, Parental Leave
  • Flexible work environment

Learn more at benefits.lubrizol.com !

Ready for your next career step? Apply today and let's shape the future together!

It’s an exciting time to be part of Lubrizol. Lubrizol is not staying put. We are continually learning and evolving. Our passion delivers our success — not only for Lubrizol but for those who count on us every day: our employees, customers, and communities.

As a diverse, global team, we work together to solve some of the world’s most pressing challenges. We impact everyday lives through science only Lubrizol can deliver, and we never stop pushing to do it better.

One of the founding principles of The Lubrizol Corporation more than 90 years ago was treating every employee with dignity and respect. That same commitment is only stronger today. More than that, we are committed to providing an environment where every employee can be the best they can be, no matter their race, color, religion, sex, national origin, sexual orientation, gender identity, disability, or protected veteran status, or any other characteristic.

 

#LI-EF2

Job Tags

Holiday work, Full time, Contract work, Remote job, Flexible hours,

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