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| Company |
Medtronic |
| Title: |
Prin Product/Process QA Engineer 63104 |
| Category: |
Quality Assurance / Safety |
| Description: |
| Prin Product/Process QA Engineer
Requisition 63104
Category Regulatory Affairs and QA
Business Cardiac Rhythm Disease Mgmt
Division CRDM Quality
Location USA-MN-Mpls-Mounds View
Relocation Relocation eligibility to be determined
Job Type Full Time - Regular
Exempt/Non-Exempt Exempt
Shift First
Travel Percentage less than 10%
Experience Required 5 years
Education Required Bachelor of Science
Position Description
Provide Quality Assurance engineering support for medical device product, process and manufacturing technology development. Serve as local Process Quality Assurance liaison with the high volume manufacturing facility Quality Assurance groups.
Through regular interaction with Manufacturing, Design, Regulatory Affairs, and other Quality partners, drive quality and reliability improvements in each generation of product, and verify/validate compliance with design, manufacturing, Quality System and Regulatory requirements.
Position Responsibilities
New manufacturing process development:
-Support Rice Creek/Mounds View manufacturing technology development groups and device technology lab product and process development efforts. Interface with worldwide manufacturing Quality Assurance partners to understand product and process capability and achieve product and process consistency.
-Review characterization, qualification, and validation plans and reports for new or updated manufacturing processes. Understand the integration of component, design and process to ensure adequate design margins and process capability. Drive the use of statistics analysis tools to understand process margins and capability. Ensure compliance to specifications and regulatory requirements.
-Provide product/process input by reviewing legacy product/process performance and assessing new product/process technology risks. Participate in cross-functional teams to asses design and process risks through FMEAs, Fault Tree Analyses, etc., and provide process quality assurance inputs at review boards. Participate in establishing and reviewing specifications/requirements for components, products and processes.
-Provide feedback on manufacturing related documentation for regulatory submissions and product release.
Manufacturing Process Change Assessment and Field Issue Resolution:
- Interface with other Medtronic facilities/locations on product transfers.
-Review product and process changes and assess impact on product reliability, process capability and qualification/validation status. Assist in change implementation.
-Partner with the high volume facilities QA partner to monitor the production and design operations for a specific product or group of products from design implementation through the transfer to high volume production. Interface with other Medtronic facilities/locations/suppliers to identify, trend, investigate and resolve product quality issues and to identify and address continuous improvement opportunities. Perform Corrective Action and Preventive Action activities, as applicable.
Basic Qualifications
EDUCATION
BS or higher in Engineering, Physics, Materials Science, Chemistry, or related technical field.
EXPERIENCE
5-9 years in a development or manufacturing environment, including 2-4 years in Quality Assurance, Reliability Assurance, medical device manufacturing or electronics manufacturing.
SKILLS/COMPETENCIES
Statistical skills (DOE, ANOVA, SPC, Gage R&R)
Demonstrated technical writing skills
Adept at using a computer
Experience working with cross-functional teams (FTA/FMEA Facilitation, etc.)
Experience in problem solving methodologies (8-D, Root Cause Analysis, etc.)
Training in Design of Experiments and Statistical Process Control
Background in Quality Systems and Corrective and Preventive Actions implementation
Desired/Preferred Qualifications
Well developed communication skills
FDA/ISO Experience
Six Sigma Certification
Lean manufacturing experience
CQE or CRE certification
SPC Experience
Physical Job Requirements
Mobility Requirements: Stand/Sit/Walk 8 hrs/day; travel across campus on own power.
Dexterity Requirements: Able to use computer & monitor to develop, review, and communicate job-related documentation. Able to use microscope to conduct fine/close work.
Vision requirements: Correctable to 20/20 in 1 eye and 20/40 in other eye. Able to use computer & monitor to develop, review, and communicate job-related documentation. Able to use microscope to conduct fine/close work.
Hearing requirements: Able to participate in meetings and conference calls and use telephone.
Physical requirements: Able to meet Clean Room requirements and work around chemical solvents and Laser equipment. |
| Skills: |
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| Employment type: |
Full Time |
| Salary: |
Unspecified |
| Degree: |
Unspecified |
| Experience: |
Unspecified |
| Location: |
Mounds View - Twin Cities - Through Out |
| Post Date: |
2008-07-23 |
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