Process Quality Engineer Job in Plymouth 55442, Minnesota Us
POSITION SUMMARY
Covidien is seeking a Process Quality Engineer to perform Quality Engineering activities for on-going manufacturing line support through the application of ‘best practice’ engineering techniques. This person must also ensure these activities are accomplished in compliance with applicable industry/regulatory standards and company quality objectives.
PRINCIPLE ACCOUNTABILITIES
• Possess and apply knowledge of process control tools and analytical techniques (i.e. SPC, DOE, cause and effect, etc.) to maximize the quality and flow of product through the production line
• Lead investigations into non-conforming material including definition of scope, investigation into root cause, disposition of product, and implementation of corrective actions
• Provide statistical guidance to test protocols/reports and ensure that the testing is sufficient to meet regulatory requirements and quality objectives
• Identify and manage risk through the product life cycle with the use of FMECA and/or other risk management tools
• Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested
• Analyze and investigate returned products to determine the cause for return and recommend corrective actions
• Participate in supplier selection process and specification reviews with suppliers to ensure that purchased items meet specifications
• Specify quality characteristics and inspection plans for components, subassemblies, and finished devices
• Comply with applicable FDA and international regulatory laws/standards and the Covidien Code of Conduct
REQUIREMENTS
• Bachelor’s Degree in Science or Engineering (or related field)
• CQE certification is desirable
• 2 - 4 years experience in Quality Engineering in the medical device industry (or related industry). Experience in related engineering areas, e.g. RD or Manufacturing is beneficial.
• Proficient computer skills and demonstrated competence to include word-processing, database applications, and spreadsheet in a network environment
• Good mechanical aptitude and methodical problem solving skills desirable
• Demonstration of self-motivation and leadership skills
• Ability to manage time efficiently and multi-task
ARE YOU COVIDIEN?
As a global, $10+ billion healthcare products leader, we deliver outstanding results and innovative solutions for challenging problems. Through progressive thinking and cutting-edge technologies, Covidien is well positioned to lead the way in today’s rapidly changing healthcare industry. Whatever your specialty or ambitions, you can make a difference at Covidien – both in the lives of others and your career.
This position is part of Covidien’s Vascular Therapies global business unit which delivers a broad range of innovative solutions for vascular disease and prevention. Vascular Therapies is organized in three divisions—Neurovascular, Peripheral Vascular, and Venous Vascular—and includes people and products from recent acquisitions of ev3, Bacchus Vascular and VNUS Medical Technologies. Located in Plymouth, MN, our Peripheral Vascular division is a rapidly growing, global medical device manufacturer that’s committed to developing innovative endovascular technologies for peripheral applications.
Creative, competent people with a passion for enhancing healthcare around the globe have driven our success.
A competitive base salary with annual bonus potential, excellent benefits, and the opportunity to improve the lives of people everywhere, truly makes us an employer of distinction!
We are an affirmative action/equal opportunity employer.