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Quality Director

Smith+Nephew
United Statesfull_timeVerifiedPosted 10 Feb 2025

About the role

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. ​This position will be responsible for all Operations Quality Engineering activities at the Memphis site. 

What will you be doing?

The successful candidate will be an integral member of the site’s Quality management team and will possess outstanding Quality operational and system experience/skills. In this role, the Quality Engineering Director will act strategically to support and sustain Smith & Nephew’s quality system, ensure timely resolution of quality investigations and CAPAs, collaborate with manufacturing leaders to ensure product quality, lead quality improvement projects and ensure Good Manufacturing & Documentation Practices (GMP and GDP) in manufacturing operations. This role will serve as a delegate to the local Management Representative for the Quality System and Person Responsible for Regulatory Compliance (PRRC) in the absence of the Sr. Quality Director.​

  • ​​​Develops strategy within Quality Engineering to best support Operations 

  • ​Leads Quality Engineering Managers and other technical personnel within a manufacturing environment.  

  • ​Ensures processes and procedures are followed in all aspects of Manufacturing and Quality Systems. 

  • ​Works collaboratively with cross functional teams to ensure product quality 

  • ​Accountable for the quality metrics for the Memphis site 

  • ​Assures that the quality system is implemented such that certifications and registrations will be maintained; assure that proper communication with senior management is maintained; coordinate data collection for periodic Management Reviews.​​ 

What will you need to be successful?

​8-10 years’ experience in a Quality role in a medical device company. 

Strong analytical skills, problem solving techniques and statistical application experience.

5-8 years' experience proven in leading people/teams, prioritizing and handling projects and developing/mentoring/guiding team members.​ 

​​​Ability to assess current Smith & Nephew practices with external standards (GMP’s, ISO 13485, EN, J-GMP, and MDD), guidance, and regulations.

Provide and implement solutions to quality problems.

Requires well-developed written, oral, interpersonal, and organizational skills.

Team player, maturity, excellent judgment.​ 

BS in an Engineering discipline

License/certification: ​ ASQ CQM, CQE preferred​ 

You Unlimited.

  • Inclusion, Diversity and Equity - We are committed to welcoming, celebrating and thriving on Diversity! Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/)  
  • Your Future: 401K Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement  
  • Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays,

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Company

Smith+Nephew

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