Quality System Specialist II (Fort Worth, TX)

Smith+Nephew•Fort Worth, TX

9d•Hybrid

About The Position

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.

Requirements

Bachelor’s degree in science, engineering, life sciences or related field required.
2-5 years' experience in a quality systems role within medical device, pharmaceutical or biotech manufacturing is required.
Deep understanding of cGMP and FDA regulations.
Microsoft Office Project or Excel, Word, and PowerPoint proficiency.
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 in maintaining accurate, real-time records of inspections, deviations, and corrective actions

Nice To Haves

Lean or Six Sigma Yellow or Green Belt is preferred
Auditor training or certification is preferred.
Familiarity with 21.CFR Part 11, 58, 210, 211, 600, and 820 preferred.

Responsibilities

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.