2-5 years' experience in a quality systems role within medical device, pharmaceutical or biotech manufacturing is required.
Certifications:
Lean or Six Sigma Yellow or Green Belt is preferred and auditor training or certification is preferred.
Knowledge:
Deep understanding of cGMP and FDA regulations.
Familiarity with 21.CFR Part 11, 58, 210, 211, 600, and 820 preferred.
Microsoft Office Project or Excel, Word, and PowerPoint proficiency.
Competences:
Ability to apply problem-solving methodologies effectively
Ability to work collaboratively with site personnel to solve issues
Must be proficient with Microsoft Word, Excel, and PowerPoint
Excellent communication (oral and written) and attention to detail
Strong planning and organizational skills.
Ability to articulate quality issues effectively and provide constructive feedback to personnel.
Effective verbal and written communication skills
Ability to in maintaining accurate, real-time records of inspections, deviations, and corrective actions
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
The Quality Management Systems Specialist II is responsible for compliance, maintenance, and oversight of the Quality Management Systems managed at the Fort Worth Facility to ensure the systems function in compliance with corporate and regulatory agency requirements.
What will you be doing?
Managing the quality management system to ensure alignment with internal procedures and regulatory standards, with ownership of CAPA, non-conformance and change management processes
Leading and coordinating key governance forums including CAPA Review Board, QMR, QDR and change control
Generating KPIs, trend analysis and management reports to provide visibility to site leadership
Driving continuous improvement using Lean or Six Sigma methodologies to reduce quality events and strengthen root cause problem solving
Supporting and preparing for internal and external audits and helping the site maintain a strong state of readiness
Providing guidance, coaching and quality input to teams across the manufacturing environment.
What will you need to be successful?
Education:
Bachelor's degree in science, engineering, life sciences or related field required.
Smithnephew · Fort Worth