Job Title:  Quality Manager

The Quality Manager role provides quality support and leadership to ensure the successful development of products and materials. The role applies knowledge of design control principles and quality engineering techniques to positively influence development efforts.  In parallel, this position shall ensure the products are developed and manufactured in accordance with quality procedures, applicable industry standards, regulatory requirements, and customer requirements.  Review and evaluate scientific and technical data as it pertains to product and product testing and lead teams to identify and solve complex product problems.

Position Requirements

Bachelor’s degree in Engineering or related field with at least 5 years of quality engineering (or equivalent experience) required.

Quality Management Systems experience.  Medical device industry under FDA US 21 CFR 820 and ISO 13485 Medical Device experience preferred.

Experience with risk management assessments and techniques, preferably in accordance with ISO 14971.

Experience with product development and quality principles and practices.

Experience leading and facilitating audits as well as managing remote teams internationally is preferred but not required.

Strong interpersonal, organizational and project management skills are required.

Demonstrated ability to work productively with individuals at all levels inside and outside the organization, with an ability to influence key company and customer decision makers.

Demonstrated proficiency with best-in-class data analysis tools, statistical process control software, customary PC office applications such as Word, Excel and PowerPoint required.

Fluent in Spanish and English.

Ability to communicate effectively with customers internationally (primarily in the US).

Ability to travel, both Internationally and Domestically 15-25% of time.

Duties and Responsibilities

Actively represent Quality Assurance function on product/process development teams.

Manage department resource allocation across multiple product lines.

Establish and install a vision for QA team, define objectives, manage team performance and coordination of assignments.

Provide Quality Engineering leadership by direct management and development of department employees and indirect management and development of Engineering and audit resources.

Define and manage development plans and opportunities for department employees.

Aggressively identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, FDA, US 21 CFR 820 (QSR), ISO 13485, etc.

Identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility.

Provide strategy and structure for product quality through New Product Development processes,  CAPA investigations and executions in the early stages of product development including, but not limited to customer/supplier interaction, product engineering, and prototype testing.

Lead and manage quality engineering teams supporting new product launches and site product transfers to ensure successful launch and/or transfer of the product.

Report on the performance of Quality Systems to company management for review and ensure management reviews are held.

Provide Quality Leadership for the business unit and provide reports on Product Life Cycle Management, CAPA and Risk Management, etc.

Lead the investigation of complex product problems to identify and manage corrective actions resulting from problem investigations.