Quality Systems Engineer - II

March 11

Apply Now

Receive Emails with Similar Jobs

Integer Holdings Corporation

WebsiteLinkedInAll Job Openings

Integer Holdings Corporation is a leading provider of advanced medical device outsourcing services. With a rich history of 80 years, Integer specializes in the design, development, and manufacturing of medical devices and components. It serves major global OEMs by offering a wide range of products such as finished device systems, Class III Medical Devices, and components for cardiac rhythm management, neuromodulation, and vascular health markets. Integer is renowned for its manufacturing excellence, innovation, and commitment to enhancing patient lives through high-quality medical solutions. The company operates globally, providing unique design expertise, comprehensive product development, and strategic partnerships in the medical device industry.

Medical device outsource (MDO) manufacturer • R&D Capabilities • Transfer to Manufacturing • Manufacturing Process Oversight • Quality/Regulatory

10,000+ employees

Founded 1970

⚕️ Healthcare Insurance

💊 Pharmaceuticals

🧬 Biotechnology

💰 Post-IPO Debt on 2023-01

📋 Description

• Leads the execution and improvement of quality assurance and quality systems activities. • Develops and manages quality systems that comply with national and global regulatory requirements. • Develops new and unique approaches to complex problems and advance technology beyond previous company involvement. • May lead and conduct detailed quality analyses including cost of quality trends and root cause analyses. • Under the occasional supervision of experienced quality engineering mentors and managers, you will select and apply standard quality engineering techniques, procedures, and criteria in making adaptations and modifications to existing products and processes. • Leads the development and implementation of continuous improvement projects related to the electronic quality management system and quality system Power BI tools. • Perform work on technical projects where you will follow Integer’s standard quality management methodologies to investigate opportunities for quality process improvements. • Apply standard data analysis practices and techniques to establish root cause for quality system issues. • Collaborate with others in the exchange of information, ask questions and regularly check for understanding in support of your development as an engineer. • Plans/develops engineering projects concerned with unique or high-profile problems which have important effect on major organization programs. • Embed Quality within your daily work life – “I own Quality.” • Be a standard bearer for Quality in everything we do at Integer, by assuring adherence to our Quality Management System (QMS), facilitating and/or contributing to corrective and preventive actions, and contributing to the successful attainment of our quality KPI’s and journey to differentiated quality. • Assists with quality assurance functions in support of needs directed by Quality Management. • Performs other duties as required.

🎯 Requirements

• Minimum Education: At a minimum you have earned a bachelor’s degree in an engineering or related field and 3 years relevant experience. • Candidates who do not meet the education requirement may be considered with 5+ years of relevant experience. • You possess experience with development and configuration of electronic quality management system software and Power BI tools. • You demonstrate a solid technical aptitude with the ability to be an effective contributor to a team or produce results of a technical nature as an individual. • You demonstrate a competency in both written and oral communications. • You maintain a calm demeanor that transcends the high energy, constantly changing work environment. • You possess a positive, can-do attitude with an underlying belief that failure is not an option.