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Quality Technical Writer

Location:Durham, NC
Employment Type:Full Time
Description:
TransEnterix is committed to support our customers as valued partners by creating long-term relationships and continually exceeding their expectations. TransEnterix employees as a team have created the company’s success. As a result of that success, we are looking for individuals who want to work with leading edge technology, be intellectually challenged, and be part of a team that makes a difference in healthcare outcomes.

TransEnterix strives to attract and retain the best talent that our industry has to offer. We provide a professional and challenging work environment where employees can grow and share in the continued success of the company. Individuals who thrive in our environment are team-oriented, self-motivated, creative, persistent and don’t let barriers block their progress. And importantly, they recognize and understand the importance of the customer as TransEnterix’s valued partner. The TransEnterix team includes specialists in the areas of science, engineering, production, sales, marketing, finance, human resources, regulatory, administrative support and more.

PURPOSE:

Responsible to develop and implement the Company’s quality system in accordance with applicable regulations. Responsible to implement and manage the Company’s internal audit program and CAPA program. The Quality Technical Writer will develop and implement training programs for related areas. Manage the company customer complaint program.

Project a positive and supporting approach to staff on related programs. Train and coach employees on methods to support related programs.
Duties:
•Develop and implement procedures for compliance to requirements such as ISO 13485, EU’s Medical Device Directive, Quality System Regulation 21 CFR Part 820. Manage the corporate quality manual. F low chart processes and systems for inclusion in procedures. Assist other departments in the development and documentation of procedures and processes.

•Develop and execute training programs for the QS Regulation, ISO 13485 standard, TransEnterix Quality Manual, and CAPA program. Responsible to train company personnel to assist in internal audit program.

•Manage and execute internal audit program. Report internal quality audit metrics for management review.

•Participate in external third party audits representing the quality system.

•Manage the CAPA program assuring that CAPA are completed in a responsible manner and within specified time limits including closure and effectiveness. Facilitate CAPA teams as needed and assist departments and employees in the completion of CAPA. Provide positive support and promote teaming with regard to CAPA to assure a positive company response to problem solving. Provide training and coaching on problem solving techniques and methods. Report CAPA metrics for management review.

•Manage the customer complaint system including auditing and trending customer input to capture applicable complaints or reportable events. Review complaint results to assure root cause analysis and appropriate and timely customer correspondence. Report customer complaint metrics for management review.

•Generate quality reports for review and approval of management.
Qualifications:EDUCATION:

•BS degree and 0-2 years of experience in a related technical field.

EXPERIENCE:

•at least 5 years of experience in the medical device field or in a related area

•Familiar with a variety of the field's concepts, practices, procedures and regulations.

•Quality systems development experience in a medical device industry required.

•ISO 13485 inspections experience required; and FDA inspections experience a plus.

•Internal audit program management experience required.

•CAPA experience required.

•Organizational planning experience required.

•Metrics reporting experience required.

•Internal operating procedures related to quality systems management and compliance.

•Quality auditing certification a plus.

TransEnterix is an Equal Opportunity Employer


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