Quality Management Systems Manager Job Vacancy in Smith & Nephew Fort Worth, TX 76107 – Latest Jobs in Fort Worth, TX 76107 – updated today

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Full Details :
Company Name :
Smith & Nephew
Location : Fort Worth, TX 76107
Position : Quality Management Systems Manager

Job Description : Role Overview
The Quality Systems Manager is responsible for managing Quality personnel and overseeing the Quality Systems group in Fort Worth. They are responsible for ensuring that the Quality Systems are established and functioning as intended and fully comply with all regulatory agency guidelines and requirements.
Responsibilities

Responsible for the creation and management of key Quality Management Systems, both internal and external to the company, related to the manufacturing, testing and release of pharmaceutical products and medical devices.
Implements the quality management system and ensuring functional compliance to the applicable FDA’s GMP’s, international standards and state requirements (Smith & Nephew and outsource suppliers).
Manages activities within the quality area related to non-conforming material, CAPA, investigation, complaints, problem solving, trending, etc with suppliers and CMO’s as well as internal manufacturing.
Internal Audits and external auditing of contract laboratories, manufacturers, and warehouses to ensure compliance with GMP requirements
Responsible for overseeing the management of the EDMS Master Control, Smart Solve, and the Document Control group.
Ensures that quality reporting (e.g. quality trends and metrics, QMR, service report analysis, categorization and CAPA activity, etc.) is documented and completed on schedule.

Location
Fort Worth, TX
Education
BS in Chemistry or related scientific discipline is required.
Licenses/ Certifications
Relevant certifications preferred (ASQ, CQE, CQA)
Experience

A minimum of 5-7 years experience in a Quality Assurance/Systems capacity is required with demonstrated successful management responsibilities in the pharmaceutical industry, as well as experience in an FDA regulated environment.
Thorough knowledge of at least the GMP, ICH, EMEA, FDA, and Cosmetic guidelines, and working knowledge of the US Food & Drug Act.

Competences

Team player with excellent judgment and strategic vision
High energy level
Ability to work outside of scheduled hours if needed
Good interpersonal skills, patience, persistence, with the ability to train and mentor members of their group
Ability to convey a professional image to customers
Strong computer, scientific, and organizational skills
Excellent communication (oral and written) and attention to detail
Ability to work independently with little to no supervision and as part of a team. Self-motivated, adaptable, and have a positive attitude
Ability to learn new techniques quickly, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies

Travel Requirements
< 25% Job Type: Full-time Pay: Up to $125,000.00 per year Benefits: 401(k) 401(k) matching Dental insurance Flexible schedule Health insurance Paid time off Professional development assistance Tuition reimbursement Vision insurance Schedule: Monday to Friday Supplemental Pay: Bonus pay Ability to commute/relocate: Fort Worth, TX: Reliably commute or planning to relocate before starting work (Required) Application Question(s): If you have experience with all or any of the options below, please indicate which one and years of experience for each: GMP:ICH:EMEA:FDA:Cosmetic Guidelines: Salary expectation ($) Experience: Quality Assurance/Systems: 5 years (Required) medical industry/Pharma: 5 years (Required) FDA regulated environment: 5 years (Required) working knowledge of the US Food & Drug Act.: 3 years (Preferred) Work Location: One location This post is listed Under Jobs in general jobs Post Tags : , Fort Worth, TX 76107, jobs in Fort Worth, TX 76107, Quality Management Systems Manager jobs in Fort Worth, TX 76107

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