Sr Quality Engineer at Medtronic

Date: Mar 15, 2012
Location: Brooklyn Center, MN,
US Sr Quality Engineer
Requisition - 81510
Category- EngineeringBusiness
Cardiac Rhythm Disease MgmtDivision CRDM Quality
Location USA-MN-Brooklyn
CenterRelocation - No relocation assistance
Job Type Full Time - RegularExempt/Non-Exempt
Exempt Shift FirstTravel Percentage- less than 10%
Experience Required - 5 years
Education Required - Bachelor of Engineering
Medtronic is an Equal Opportunity/Affirmative Action Employer

Position Description

Leads quality activities to support the lifecycle of the product. Maintains a thorough knowledge of new developments and technology. Monitors products, processes, and projects and recommends changes to improve operating efficiency. CRDM seeks candidates who will meet our customer expectations by striving without reserve for the greatest possible reliability and quality in our products, processes and systems by being accountable, having a voice, and taking action.

Position Responsibilities

- Manages assigned product lines and manufacturing processes to ensure highest product quality and assure compliance to internal and/or external specifications and standards such as QSR and ISO regulations.
- Accountable for identifying and implementing GMP (Good Manufacturing practices) that apply to a specific product area
- Participate in development projects to ensure products and processes are designed, developed and transferred to meet appropriate compliance/regulation standards
- Leads/owns Corrective/Preventive actions (CAPA) to resolve production and customer issues. Dispositions any materials / components that are rejected for non-conformance with effective corrective and preventive actions
- Identify and/or implement quality system changes to improve the performance from a user's perspective as well as compliance to regulatory standards.
- Participates in audit/assessment of the manufacturing operations, and recommends corrective/preventive actions and process improvements.
- Applies and understands statistical methodologies, as appropriate, for conformity assessment and investigative activities.
- Communicates significant issues or developments identified during quality activities and provides recommended process improvements to team or management.
- Provide Training as needed to ensure assemblers understand and follow GMP
- Execute GMP manufacturing assessments
- Performs other related duties as assigned.

Basic Qualifications

- Bachelor's degree in Mechanical or Biomedical Engineering or related field with a minimum of 5 years of related experience working with the FDA Quality System Regulation and/or ISO 13485 quality management systems.
- Experience comprehending Quality system process documents.
- Experience understanding proper documentation/quality requirements for a regulated environment
- Experience with manufacturing systems such as JDE, Factoryworks, or SAP

Desired/Preferred Qualifications
- Demonstrated ability to lead in FDA regulated environment
- Lean, Six Sigma experience
- ISO 13485/GMP experience
- Experience with preventive/corrective action process
- Understanding of Development protocols – IQ/OQ/PQ.
- Experience working on multiple projects, priorities, and responsibilities in a fast-paced continuously changing work environment.
- Well-developed interpersonal communication, decision making, and leadership skills and able to work with internal and external customer
- Engineering tools utilization experience such as design of experiments, risk management, validation, methodical problem solving, & statistical analysis.
- ASQ Certified CQE, CQA or CRE

Physical Job Requirements
Stand/Sit/Walk 8 hrs/day
Frequent bending/stooping, squatting and balance
Ability to effectively use a PC, keyboard and mouse

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand, sit, walk, talk, hear and reach with hands and arms. The employee is required to use hands to handle, or feel objects, tools, or components.
How to Apply
Please click here to apply online:
http://www.engineerjobs.com/partnersite.php?partnerurl=http%3A%2F%2Fjobs.medtronic.com%2Fjob%2FBrooklyn-Center-Sr-Quality-Engineer-Job-MN-55428%2F1778563%2F%3FfeedId%3D142%26campaignId%3D12%26utm_source%3DEngineerJobsPPC%26utm_campaign%3DMedtronic_Engineering