Quality Director

Posted 8 Hours Ago
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Memphis, TN
Senior level
Healthtech • Biotech
The Role
The Quality Director will oversee the Quality Engineering team and operations at the Memphis site. Responsibilities include ensuring compliance with quality standards, resolving quality investigations, managing quality metrics, and leading quality improvement projects. The role requires collaboration with manufacturing teams to uphold product quality and adherence to GMP and regulatory guidelines.
Summary Generated by Built In

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, Flex Holidays, Paid Community Service Day  
  • Your Wellbeing: We offer Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program  
  • Flexibility: Hybrid Work Model (For most professional roles)  
  • Training: Hands-On, Team-Customized, Mentorship  
  • Extra Perks: Discounts on fitness clubs, travel and more! 

Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.

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Check our Glassdoor page for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N.

Explore our new website and learn more about our mission, our team, and the opportunities we offer. 

 

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The Company
Andover, MA
15,318 Employees
On-site Workplace

What We Do

Smith+Nephew is a global medical technology company. We design and manufacture technology that takes the limits off living. We support healthcare professionals to return their patients to health and mobility, helping them to perform at their fullest potential.

From our first employee and founder, T.J. Smith, to our team today, it’s our people who make Smith+Nephew a unique place.

Yes, we love to innovate and develop exciting technologies, and we offer competitive salaries and progressive benefits. But it’s our culture - of Care, Collaboration and Courage - that really sets us apart.

Through a spirit of ownership and can-do attitude, we work together to win..

We’re a company of people who care about each other, about our customers and their patients, and about our communities.

Together, we fulfill our shared purpose of Life Unlimited.

Please note: not all products referred to may be approved for use or available in all markets.

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