About
By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success. At Integer, our values are embedded in everything we do. Customer We focus on our customers' success Innovation We create better solutions Collaboration We create success together Inclusion We always interact with others respectfully Candor We are open and honest with one another Integrity We do the right things and do things right Key Accountabilities and Responsibilities You adhere to Integer's Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements. As a quality Core Team member, actively participates in development project teams. Performs quality/reliability engineering activities to ensure that the design/development procedures, design controls, supplier controls and test requirements are fulfilled. Generates and/or reviews related project deliverables, such as design verification and design validation protocols and reports; and process validation protocols and reports. Participates in risk assessment and mitigation activities (FMEA, FTA, etc.) in support of new product development. Supports Product Development Manufacturing Engineering in development of test fixtures/ test methodology, develop production acceptance criteria and test methods. Coordinates the preparation of Quality Plans, including inspection and gauge requirements. Provides support for root cause analyses, CAPA and Distributed Product Risk Assessment and updates SOPs as required. Coordinates sourced item qualification activities and supports supplier risk management initiatives. Performs other functions as required. Job Requirements Minimum Education: You earned, as a minimum, a bachelor's degree in an engineering or related technical field; and have at least three years of relevant experience. Candidates who do not meet the education requirement may be considered with 7+ years of relevant experience. Specialized Knowledge: Experience with statistical software packages such as Minitab. Demonstrated problem solving skills. Knowledge of ISO and FDA quality, process validation and system requirements Experience in interpreting design schematics and drawings Skilled in statistical methods e.g. ANOVA, SPC, sample size determination, Gauge R&R and DOE. Knowledge of quality lean sigma tools (e.g. Root Cause Analysis, QFD, Ishikawa, Kepner-Tregoe). Special Skills: Strong written and oral communication skills, including technical writing. Demonstrated ability to work in a team environment. 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 have a functional understanding of the Integer Quality Management Systems and are able to complete required Quality System documentation tasks with little or no direction from others. You demonstrate competency in both written and oral communications. You maintain a calm demeanor that transcends the high energy, constantly changing production environment. You possess a positive, can-do attitude with an underlying belief that failure is not an option.
Languages
- English
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