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Quality Systems Specialist III (Fort Worth, TX)

Smith & Nephew Plc

Fort Worth, TX

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JOB DETAILS
SKILLS
Analysis Skills, Auditing, Biology, Biotech and Pharmaceutical, Change Management, Coaching, Communication Skills, Continuous Improvement, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Current Good Manufacturing Practice (cGMP), Customer Support/Service, Detail Oriented, External Audit, FDA (Food and Drug Administration), FDA Requirements, Fitness, GMP (Good Manufacturing Practices), GxP, ISO (International Organization for Standardization), Internal Audit, Leadership, Lean Six Sigma, Lift/Move 40 Pounds, LinkedIn, Maintain Compliance, Manufacturing, Manufacturing Systems, Medical Equipment, Mentoring, Microsoft Office, Physical Demands, Presentation/Verbal Skills, Problem Solving Skills, Process Improvement, Quality Management, Quality Metrics, Regulations, Regulatory Compliance, Regulatory Requirements, Risk Management, Root Cause Analysis, Six Sigma Green Belt, Standard Operating Procedures (SOP), Surveillance, Systems Administration/Management, Team Player, Time Management, Trend Analysis, Willing to Travel, Writing Skills
LOCATION
Fort Worth, TX
POSTED
30+ days ago

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

We are looking for a Quality Systems Specialist 3 who will provide strategic leadership and expert support in maintaining and enhancing the maturity of the Quality Management System. This role drives compliance with regulatory requirements (GMP, GxP, FDA, etc.), leads internal and external audits, and acts as a liaison between the quality department and other business units to improve compliance culture.

What will you be doing?

  • Lead and maintain the Quality Management System to ensure compliance with internal policies and regulatory standards including GMP, GxP and FDA requirements
  • Manage key quality system processes including CAPA, Non-Conformance (NC) and change management, ensuring timely closure and continuous improvement
  • Generate and analyze quality metrics to identify trends, support management reviews, and maintain visibility of QMS health
  • Coordinate and lead internal audit activities, as well as assist in external audits, and support regulatory inspections, ensuring permanent readiness
  • Provide quality expertise on the manufacturing floor, lead investigations, and guide root cause analyses to reduce quality events year over year
  • Support manufacturing activities such as but not limited to SOP revisions, nonconformance investigational support, risk management, and post market surveillance activities.
  • Coach and mentor colleagues, facilitating the use of problem-solving methodologies and promoting a culture of continuous improvement

What will you need to be successful?

Education:

  • Bachelor's degree in science, engineering, life sciences or related field

Certifications:

  • Lean or Six Sigma Yellow or Green Belt preferred.
  • Certified Quality Auditor (CQA) or Lead Auditor training (ISO 13485) highly desired

Experience:

  • Minimum of 5 years of experience in a Quality Systems role within pharmaceutical, biotech or medical device industries
  • Experience with GMP, FDA regulations, internal audits and quality investigations

Knowledge:

  • Proficiency in MS Office tools and high attention to detail
  • Deep understanding of cGMP (current Good Manufacturing Practices), and FDA guidance and regulations.
  • Adherence to Quality Systems and Good Manufacturing Practices with high level of attention to detail

Competences:

  • Strong problem-solving skills with the ability to coach teams and influence cross functional groups
  • Ability to work collaboratively with site personnel to solve issues.
  • Effective verbal and written communication skills

Other requirements:

  • Physical Demands: While performing the duties of this position, the Employee will be required to walk, stand, lift (up to 40 lbs), climb ladders/stairs, and work in high noise spaces.
  • Travel Requirements: Up to 10% (international and domestic)

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 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!

#LI-ONSITE

#LI-CA1

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.

Stay connected by joining our Talent Community.

We're more than just a company - we're a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day.

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

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

About the Company

S

Smith & Nephew Plc

The Group has a history dating back 160 years to the family enterprise of Thomas James Smith who opened a small pharmacy in Hull, England in 1856. On his death in 1896, his nephew Horatio Nelson Smith took over the management of the business. Thomas James Smith black and white photograph Image: Thomas James Smith A few days after the declaration of World War 1 in 1914, Horatio Nelson Smith (the nephew of the company founder T. J Smith) met with an envoy of the French President in London. The company was awarded a contract to supply £350,000 of surgical and field dressings, to be delivered in five months. By the late 1990s, Smith & Nephew had expanded into being a diverse healthcare conglomerate with operations across the globe, including various medical devices, personal care products and traditional and pioneering woundcare treatments. In 1998, Smith & Nephew announced a major restructuring to focus management attention and investment on three business units — wound management, endoscopy and orthopaedics — which offered high growth and margin opportunities. Smith & Nephew was incorporated and listed on the London Stock Exchange in 1937 and in 1999 the Group was also listed on the New York Stock Exchange. In 2001, Smith & Nephew became a constituent member of the FTSE-100 index in the UK. This means that Smith & Nephew is included in the top 100 companies traded on the London Stock Exchange measured in terms of market capitalisation. Today, Smith & Nephew is a public limited company incorporated and headquartered in the UK and doing business in many countries around the world.
COMPANY SIZE
2,000 to 2,499 employees
INDUSTRY
Medical Devices and Supplies

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