Job Description
Develop and implement appropriate quality system elements to ensure the high quality level of new and existing products as well as their compliance to applicable regulations and standards. Work with problems of moderate scope where the analysis of situation or data requires a review of identifiable factors. Exercise judgment to determine appropriate action. Communicate and implement quality objectives.
Interface with other engineering departments within the company, customers, and suppliers on quality related issues
Perform failure analyses and defect investigations
Analyze production limitations and standards
Participate in the development and qualification activities for new and existing products
Design or specify inspection and testing mechanisms and equipment
Participate in the development of standard operating procedures
Facilitate and perform internal audits
Skill set 1-5 years quality engineering experience, preferably in a medical device environment, or equivalent combination of education and experience; familiarity with QSR, ISO and other applicable regulations and laws. Knowledge of statistics packages (MiniTab, JMP); a high degree of proficiency in standard office tools, including Excel, Access, Word and Power Point. Risk management experience desired. Strong oral and written communication and teamwork skills.
Perform failure analyses and defect investigations
Analyze production limitations and standards
Participate in the development and qualification activities for new and existing products
Design or specify inspection and testing mechanisms and equipment
Participate in the development of standard operating procedures
Facilitate and perform internal audits
Skill set 1-5 years quality engineering experience, preferably in a medical device environment, or equivalent combination of education and experience; familiarity with QSR, ISO and other applicable regulations and laws. Knowledge of statistics packages (MiniTab, JMP); a high degree of proficiency in standard office tools, including Excel, Access, Word and Power Point. Risk management experience desired. Strong oral and written communication and teamwork skills.
Job Application Accepted Via Email: deborah.bain@penumbrainc.com
