Quality Systems Specialist III (Fort Worth, TX)

Smith+Nephew•Fort Worth, TX

1d•Onsite

About The Position

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.

Requirements

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

Nice To Haves

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

Responsibilities

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