Are you Covidien?

Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes & delivers value through clinical leadership & excellence. We deliver outstanding results & innovative solutions in the Medical Device & Medical Supplies segments. Through progressive thinking & 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 & your career. At Covidien, we strive to fully understand our marketplace, customers, communities & employees, & we enter into relationships with a sense of honesty, fairness & trust. We are an affirmative action/equal opportunity employer.

Process Engineer (2 open positions)
Position Summary • Responsible for the engineering support of the manufacturing processes, machine and/ or assembly problem resolution and product improvements. • Candidate must be organized and able to plan, track, and manage small and medium size capital projects as well as process improvement projects through completion. • Responsible for supporting all other manufacturing objectives including cost reduction projects, capacity improvement projects and lean initiatives. Principal Accountabilities • To support and assist all manufacturing areas in controlling efficiencies, utilization and product quality on a daily basis. • Aid in troubleshooting equipment and process issues utilizing cause and effect analysis to debug and qualify equipment. • Establish, manage, and coordinate product maintenance and product improvement projects covering all areas of product/packaging design, including manufacturing and assembly techniques and equipment. • Establish, manage, and coordinate programs of continuous improvement, cost savings or cost reductions • Execute and manage all aspects of document change management Requirements • The ideal candidate will have a basic knowledge of machinery, materials, automated assembly, and FDA regulated validations. • This position may have an engineering technician reporting into it. Education: Bachelor degree in Engineering in a related discipline. Job Competencies • Execute validation (IQ, OQ, PQ), CAPA projects and serve as a technical resource in addressing manufacturing non-conformances. • Provide direction to production associates and technicians. • Look for and execute production and safety improvements.

Ops Quality Engineer I (2 positions available)
Position Summary • Provide tactical process improvement, and change management support to external suppliers (and affected internal groups) in resolving quality, productivity, and routine technical issues related to new and existing products during all phases of the product life cycle. • Work with Incoming Quality Control and provide technical direction to QC Inspectors. Principal Accountabilities: • Management of Material non-conformances - 60%  Complete the analysis and resolution of material non-conformances using various problem solving techniques in support of Material Review Board (MRB) decisions.  Track supplier corrective action Requests (SCAR) including issuance, follow up, and closure activities.

Ensure that supplier non-conformance events are closed with a sense of urgency, in a timely fashion, and minimal disruption to manufacturing. • Perform qualifications to support changes to existing components or new components and materials - 10%  Assist with the qualification of new suppliers, new components, and changes by developing and executing, in conjunction with other internal groups, a robust and complete set of plans and requirements for such qualifications. • Interfaces with External Suppliers -30%  Maintain a professional, ethical, and credible image with suppliers and internal functions, ensuring that this position is deemed a resource person to Sourcing, Manufacturing, and External Suppliers.  In conjunction with Sourcing, initiate supply chain based improvements such as Dock to Stock, cost improvements and consolidation projects.  Conduct supplier visits per audit schedule, as needed, and in support of issue resolution with detailed reports and agreed actions in conjunction with the supplier and other internal groups. Requirements: Any combination equivalent to, but not limited to, the following: • Education/Training/Experience:  Bachelor of Science degree in engineering, physical life sciences, or related technical field with 0 to 3 years experience in quality in the medical device industry or 0-2 years experience with an applicable MS degree.  ASQ certification or equivalent preferred • Knowledge/Skills/Abilities:  Knowledge of basic quality tools, risk analysis, statistics, design of experiment  Basic reading and math  Reading drawings  Computer literate; use of word processing, spreadsheets  Quality System Requirements  ISO procedures / FDA requirements  Medical Device Directives (MDD)  Use of various tools, including microscopes, calipers, and other inspection equipment  Recognize problems and take corrective measures  Excellent written and verbal communication skills  Self-motivated and committed to a team approach • Physical Requirements  Typically requires close visual attention to work being performed and considerable sitting for long periods of time with occasional stooping, bending, reaching, standing, grasping, feeling, etc.  May require occasional lifting, carrying, pushing, pulling, or to otherwise move objects of up to, but not limited to, 20 lbs.  Frequent repetitive motion tasks performed.