Theragenics’ Brachytherapy business, located in Buford, Georgia, manufactures, markets and distributes “seeds” used primarily in the minimally invasive treatment of localized prostate cancer. We are currently seeking a Manager of Quality & Regulatory Affairs to join our team.
Provide guidance and ensure compliance with the Quality System Regulations including FDA, ISO 13485, and applicable international regulations. Develops and implements strategies for implementing the company's quality objectives through the activities of the department and cross-functional quality teams. Serves as a mentor to company personnel by training in quality system requirements and the use of quality tools for continuous process improvement. Provides guidance to internal departments on quality and regulatory compliance issues.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Conduct Management Reviews and periodic Quality Team meetings and hosting external quality audits.
Manage the implementation of the company’s quality objectives through specific improvement projects and routine processes.
Serve as mentor to other departmental personnel by training in QSRs and the use of
quality tools for continuous improvement. Provides guidance to other departments on quality and regulatory compliance issues.
Advises Engineering, Manufacturing, and other departments on applicable regulations, requirements and standards.
Monitors change requests for impact on regulatory submissions. Provide updates to regulatory agencies as needed.
Directs the activities of all Quality department employees.
Trains and instructs employees company-wide in quality system requirements and company procedures.
Reviews and comments on the work of others to ensure compliance with quality system requirements.
5 + years’ quality management experience working in a medical device company.
Demonstrated proficiency with regulatory registrations and notifications.
Experience in medical device industry required.
Written and verbal skills must be excellent. Must be able to create clear, concise written communications to regulators and written quality system documentation.
Must have project management skills with the ability to lead and participate in cross-functional new product teams.
Excellent interpersonal skills that foster cooperation and commitment.
Detail-oriented with a sense of urgency for completing projects on schedule.
Ability to deal effectively with a variety of internal and external operational and scientific personnel with varying degrees of education and experience.
Must be able to prioritize multiple duties and projects.
Must be familiar with computers and able to word process documents and compile and organize data. (MS Office and other Windows based software)
Must possess strong knowledge of design controls.
Ability to delegate laterally to complete activities and projects.
We offer a comprehensive benefits package that includes medical, dental and life insurance, long-term and short-term disability protection, vacation, paid holidays, sick days and a 401(k) plan.
Theragenics is dedicated to a policy of nondiscrimination in employment on any basis including race, color, sex, religion, national origin, marital status, disability, age, sexual orientation, gender identity, veteran's status, or any other category protected by local, state or federal law. We take affirmative action to assure that all employment decisions are based on valid job requirements, and that equal employment opportunities are provided with regard to all personnel actions. Theragenics is a drug free workplace. EEO Minorities/Women/Disabled/Veterans.
Internal Number: TGX001
About Theragenics Corporation
Theragenics Corporation® is a medical device company serving the surgical products and cancer treatment markets. Our Brachytherapy business, now celebrating the 35th Anniversary of its founding, manufactures devices primarily used in the minimally invasive treatment of localized prostate cancer.