Senior Manager, Global Quality Systems (Fort Worth, TX)

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.

This position supports the improvement and maintenance of Smith & Nephew's global quality system framework. The candidate will support Quality System elements for global medical devices, biologics, and pharmaceutical organizations. The successful candidate will act as a leader for quality systems across all aspects of design, manufacturing, and post market activities to enable a high degree of compliance, flexibility and efficiency in the Smith and Nephew organization. This position will be responsible to support the design and deployment of strategies for global alignment of policies, procedures, and best practices across all Quality System Elements. The role will include Process ownership for Non- Conformance Management, CAPA Management and Quality Management Review. These strategies will be linked to our global objectives and the incumbent will be proactive in their implementation.

What will you be doing?

• Support enhancement updates, maintenance, training/competency qualifications and communication of the global Smith and Nephew Quality System elements. Act as the Process owner and representative for related IT System updates/enhancements/support/competency qualification.

• Support the reporting and analysis of enterprise level quality metrics, including data collection, analysis, statistical methods, and improvement plans/tracking for all metrics. Act as Process Owner of Management Review. Responsible for collecting data and facilitating monthly Quality Data Reviews and other required data/analytical activities and presentations.

• Promoting alignment by understanding and communicating activities, results, and requirements throughout the organization. Own the NC/CAPA Community of Practice. Actively participate in GQS Community of Practice and the Regulatory Compliance Network.

• Support health authority inspections.

• Sharing industry benchmarks and best practices throughout the organization and leading the organization in the application of said best practices. Act as a mentor to junior team members and aid in their personal & professional development.

• Interacting with peers in multiple functions to ensure awareness and maintain alignment between regulatory activities, customer needs (voice of the customer) and business objectives.

• Become a globally trusted internal business partner ensuring Care, Collaboration & Courage are a foundation to all activities.

• Develop strong relationships within Smith and Nephew leadership structure and within the management teams, specifically Quality Operations and Design Quality, NC/CAPA, Complaints & PMS, Document Control & Training.

• Other duties and responsibilities as assigned.

What will you need to be successful?

• Education:

  • BS degree in related field or equivalent required.

• Experience:

  • 5 plus Years experience with Quality System performance and application; global application of QS skills is a plus.

• Excellent problem-solving skills, Identifies and resolves complex technical, operational, and organizational problems; problems may cross disciplines; ability to perform investigations; excellent written skills specifically around NC/CAPA.

• Travel Requirements: 10%

You. Unlimited

We believe in creating thegreatest good for society. Our strongest investmentsare in our people and thepatients we serve.

Inclusion and Belonging-Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging. Learn more aboutEmployee Inclusion Groupson our website (https://www.smith-nephew.com/).

Other reasons why you will love it here!

• Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement
  Work/Life Balance: PTO, Paid Holidays, Flex Holidays, Paid Community Service Day

• Your Wellbeing: 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.