Quality Manager

To support our extraordinary teams who build great products and contribute to our growth, we’re looking to add a Quality Manager located in Austin, TX.

Reporting to the Quality Director, the Quality Manager will be responsible to develop, implement, and coordinate product assurance program to prevent or eliminate defects in new or existing products.

What a typical day looks like:

• Researches, evaluates and presents information concerning factors such as business situations, production capabilities, manufacturing problems, economic trends and design and development of new products for consideration by other members of management team.
• Suggests and debates alternative methods and procedures in solving problems and meeting changing market opportunities.
• Contributes with other top management personnel in formulating and establishing company policies, operating procedures and goals.
• Develops initial and subsequent modifications of product assurance program to delineate areas of control, personnel requirements and operational procedures within program.
• Evaluates contents of reports from product assurance program department heads and confers with top management personnel preparatory to formulating fiscal budget for product assurance program.
• Conducts management meetings with product assurance program department heads to establish, delineate and review program organizational policies, to coordinate functions and operations between departments, and to establish controls and procedures for attaining goals.
• Interface with customers on technical/quality issues and improvement initiatives.
• In charge of managing customer audits and regulatory/compliance agency audits.
• Reviews technical problems and procedures of departments and recommends solutions to problems or changes in procedures.
• Visits and confers with representatives of material and component vendors to obtain information related to supply quality, capacity of vendor to meet orders and vendor quality standards.
• Confers with engineers about quality assurance of new products designed and manufactured products on market to rectify problems.
• Reviews technical publications, articles, and abstracts to stay abreast of technical developments in industry..

The experience we’re looking to add to our team:

• Bachelors degree in Engineering or Science.
• 10+ y of experience developing, implementing and maintaining quality systems in Medical Devices industry, including people management roles experience.
• Strong working knowledge of QMSR (Quality Management System) as well as ISO 13485 2016 (for medical devices)
• Quality tools (8’s, 5 why, PFMEA, CAPA)
• Controls, Inspections in manufacturing process, incoming quality, laboratory
• Must have knowledge of national and international government regulatory agency standards.   

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