Senior Manager, Quality Engineering/QMS (Fort Worth, TX)

Senior Manager, Quality Engineering/QMS (Fort Worth, TX)

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

Senior Manager Quality Engineering (QE) and Quality Management Systems (QMS) is responsible for the Fort Worth QE/QMS team. The team supports quality technical support for all Fort Worth Vickery manufacturing, document control, NC/CAPA system ownership, change control system ownership, planned deviation system ownership, internal/external audits and training.  In addition, your team completes work order review and approval for GMP operations as well as validation protocol quality oversight and management of the Santyl stability programs.

What will you be doing?

• Ensure all quality policies and cGMP regulations are followed for the review and approval of NC/CAPA, Work Orders, change control, APR, complaints, risk management, IPC trending, and stability management.
• Ensure all quality policies and cGMP regulations are followed for the system management of NC/CAPA, change control, document control, and training.
• Support the Vickery site from a quality technical perspective in issue resolution and decision making.
• Run all internal or external audits.
• Provide support when needed for commercial product release

What will you need to be successful?

• Bachelors Degree in Science or Engineering or related field
• 5+ years in cGMP pharmaceutical/device regulated environment
• 2+ years of supervisory experience
• Excellent oral and writing skills
• Ability to keep accurate records and comply with company records

You Unlimited.

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.    

• Inclusion, Diversity and Equity: 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: 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 is committed to the full inclusion of all qualified individuals. As part of this commitment, Smith+Nephew will ensure that persons with disabilities are provided reasonable accommodations. If reasonable accommodation is needed, please alert the recruiter if you are selected to move forward. 

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.