Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.
Are you passionate about driving meaningful change in a regulated environment? This is a highly visible opportunity to lead quality transformation initiatives that directly support capacity expansion, operational excellence and quality system maturity at our Fort Worth site. As a Quality Transformation Manager, you will act as a catalyst for change, partnering across functions to deliver sustainable improvements that make a real impact for patients and the business.
What will you be doing?
Leading and executing quality transformation initiatives that increase capacity, optimize operations and strengthen quality system maturity
Acting as a hands on project manager and subject matter contributor for process redesign, system upgrades and optimization activities
Driving improvements across core quality systems including deviations, change control, CAPAs, investigations, document control and training
Serving as a functional expert for electronic Quality Management Systems such as Veeva, TrackWise, MasterControl or similar platforms
Authoring high quality technical documentation including procedures, protocols, reports and strategy documents
Collaborating and influencing across Manufacturing, Engineering, Supply Chain, QC and Global Quality to align stakeholders and deliver results
Facilitating workshops, problem solving sessions, readiness assessments and cross functional meetings
Applying strong analytical and root cause thinking to identify issues early and implement effective corrective strategies
What will you need to be successful?
8–12 years of experience in Quality Control (QC), Quality Assurance (QA), and/or Quality Systems within pharmaceutical, biologics, or sterile drug product environments.
Bachelor’s degree in a scientific or engineering discipline required; Master’s degree preferred (demonstrates advanced analytical, organizational, and leadership competencies).
Strong hands on expertise with eQMS platforms and quality processes such as deviations, investigations, CAPAs and change control
Proven experience leading transformation initiatives, process improvements or system implementations
Deep understanding of regulatory requirements for drug product, sterile manufacturing and biologics
Excellent written and verbal communication skills with the ability to influence without direct authority
A proactive, self starting approach with the ability to drive complex initiatives from concept through to completion
You. Unlimited.
We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.
Inclusion and Belonging: Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/).
Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Purchase Plan, Tuition Reimbursement
Work/Life Balance: Flexible Personal/Vacation Time Off, 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.
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Skills Required
- 8-12 years of experience in Quality Control, Quality Assurance, and/or Quality Systems
- Hands-on expertise with electronic Quality Management Systems
- Experience leading transformation initiatives or process improvements
- Understanding of regulatory requirements for drug product manufacturing
- Excellent communication skills
- Proactive approach to drive initiatives
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.
