Quality Engineer

OSYPKA MEDTEC INC•Longmont, CO

3d•$80,000 - $105,000

About The Position

Quality Engineer This position plays a critical role in maintaining and improving the quality management system elements and monitoring and trending data in an ISO 13485:2016 / 21CFR Part 820 regulated environment producing Class II and Class III medical devices and products. Organizational Competencies & Cultural Values: The mission of every employee at Osypka Medtec is dedication to serving, supporting, and improving the lives of our patients and customers by adding value through innovative quality medical devices and services. Our vision is to be a leading medical company in the development, production, sale, and marketing of permanent and temporary devices and services around the world. General Competencies: Work independently with minimal supervision and as part of a team. Perform basic to complex calculations, equations, and analysis of engineering data for equipment, processes or other types of requirements. Make decisions exercising critical technical judgement on more difficult and unusual projects. Prepare reports using monitoring and trending data with minimal supervision for engineering, quality, manufacturing, customers or suppliers. Complete necessary training and can follow Quality Management System. Establish and maintain effective working relationships with fellow employees, customers and suppliers. All employees are expected to provide customer service, communicate in an effective manner both verbally and in writing, display professionalism and integrity, as well as work efficiently, effectively and accurately. Employees should take initiative, solve problems, display good judgment, and take ownership for delivering a high-quality product or service.

Requirements

BA/BS in engineering, preferred.
Prior experience in quality engineering or quality management within the medical device industry, particularly Class II or Class III, preferred.
Strong problem-solving skills and attention to detail.
In-depth knowledge of FDA and ISO regulations for medical device manufacturing, specifically ISO 13485:2016.
Must have good verbal and written communication skills.

Nice To Haves

Experience working with manufacturing-based technology processes and principles preferred.
Experience working with Microsoft Office products, specifically Word and Excel.
Experience working with Minitab or other statistical analysis software products

Responsibilities

Collaborate with cross-functional teams to develop and implement quality processes and procedures.
Conduct risk assessments and contribute to the design and development of existing and new products.
Control of the distribution and accuracy of all the documents used in Product Development, Production and Quality Assurance.
Perform product and process validations, including test method validation and process capability studies.
Prepare data trend analysis reports for production areas, products, and processes.
Assist in the preparation of data to support Management Reviews.
Investigate and resolve non-conformances and complaints; and implement corrective and preventive actions.
Participate in internal and external audits to ensure adherence to quality standards and regulations.
Drive continuous improvement initiatives to enhance product quality and manufacturing processes.
Maintains product and company reputation by complying with federal and state regulations and industry requirements and standards.
Contributes to team effort by accomplishing related tasks as needed.
Will be required to perform other duties as required, directed or assigned.