Quality Assurance Manager (Site Lead) 456E-1363

Company: Grn Salt Lake City
Location: Boulder
Posted on: May 26, 2023

Job Description:

Quality Assurance Manager (Site Lead)
Boulder, CO Required Experience:8-10 years quality engineering in medical device manufacturing environment
Experience leading a small team
Required Education:BS Engineering preferred Rachel Taylor
Phone: 801.484.2220
Email: Rachel Taylor
Ref Id:456E-1363 Job DescriptionThe Quality Assurance Manager is a customer facing role and will provide overall quality leadership for one of 16 sites globally. Will encompassing both improvements and sustaining activities. Objectives involve ensuring patient and employee safety and the achievement of customer quality requirements, create, monitor and improve quality systems/programs, reduce quality costs and maintain compliance within FDA and ISO regulations for + $40 million in annual sales.

The role requires the above to be accomplished within principles of continuous improvement, customer driven innovation and a win first culture, while meeting company financial and other performance metrics.

Primary Responsibilities:

Oversee and implement an advanced level of world-class quality systems for planning, design of experiments (DOE), ISO 13485, quality function development (QFD), design for world-class manufacturability.

Take a leadership role as Manager and mentor supporting functional team members.

Integrate the quality function with manufacturing as a value added (real-time) support function, optimizing the continuous quality improvement process, while reducing cost and improving customer relationships.

Design and facilitate the development of quality systems for a highly regulated medical device industry to achieve customer satisfaction, increase productivity and maximize the profit margins for Company. The objective is to devise systems that facilitate good products fast without compromise.

Assure Company is conducting business within compliance to the regulations, as cost effectively and efficiently as possible.

Provide organizational assessments to upper management.

Enhance the one company systems interface capabilities, whereas optimizing the capabilities to perpetuate harmonized systems improvements, and based on deploying the best practices from the collective experience contribution of the worldwide teams.

Ensure the quality systems focus remains on continual quality improvement, while aligned with internal and external customer expectations. The results/objectives are geared on achieving an error-free (flawless) process, which will deliver products on time with world-class quality standards for improving quality, profits and generating new business.

Ensure the organization is basing improvement related decisions on factually/meaningful data, subsequently reducing waste and expediting the recognition of favorable results.

Leadership responsibility for promoting and developing Company's Environment Management System; Worldwide Quality Management Systems Software implementation/validation and harmonization (ETQ); Development; and Worldwide Supplier Quality Systems.
Performs other duties or special projects as required or as assigned by supervisor.
Knowledge & SkillsExperience with FDA and ISO 13485 requirements, and understanding of regulatory process. GRN Salt Lake City 2257 South 1100 East
Suite 203
Salt Lake City, UT 84106 USA

Keywords: Grn Salt Lake City, Boulder , Quality Assurance Manager (Site Lead) 456E-1363, Executive , Boulder, Colorado