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!
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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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Benefits
Health insuranceDental insuranceVision insurance401(k)Paid time offFlexible scheduleEquity / stock optionsParental leave
Additional Information
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
Smithnephew · Fort Worth