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Current Openings:
Quality Assurance Engineer
Education/Experience
Required:
Working
knowledge and experience with GMP/ISO13485 quality systems in a
manufacturing/assembly environment. Three to five years prior QA/QC Systems
interaction and participation. Bachelor’s Degree in Engineering or equivalent
background experience. Must be computer literate in word processing and
spreadsheets. Must be proficient with statistical programs including
Manufacturing Capability Study, Statistical Process Control, Design of
Experiments, Gauge R&R, Confidence Intervals and Sampling Size. Must
possess good people skills and ability to operate in a team environment.
Job
Duties:
-Monitoring
and reporting of quality metrics and indicators.
-Support engineering design and development activities
including test protocols, FMEA’s
and risk assessments
-Conduct
internal/supplier audits as member of Internal Audit Team
-Development of SOP’s consistent with
applicable quality standards and regulations.
-Participant
in Customer Returns/Complaint investigation and Corrective/Preventive Action determination.
-Interaction
with Engineering, Marketing, Manufacturing, Purchasing, QA/QC, and Inventory Control personnel and
departments as appropriate.
-Preparation
and review of Engineering Change Notices and Test Requests.
-Conduct
environmental monitoring of the Clean Environmental Room.
-Coordinate quarterly
sterility dose audits of products and prepare test protocols.
-Monitor
and address supplier quality issues.
-Evaluate
and enhance inspection/calibration techniques and methods.
-Other duties and responsibilities as assigned.
Molding Department
-Tool Set Up and
Production Molding Technician-
Successful candidate must have a solid mechanical aptitude
and an attention to detail to set up and run production molds in a fast paced
manufacturing environment to support the medical device industry. Minimum two years previous molding
experience preferred.
General duties include:
Set up tools and run production components
Establish and follow process run parameters
Perform in-process dimensional inspections
Maintenance of molding machines and support equipment
Trouble shooting and mold maintenance
Must be able to produce and maintain accurate legible
process documentation
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We are always accepting Resumes.
Feel free to Mail, Fax or Email your Resume to the address listed below.
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