Overview
Sr Design Quality Assurance Engineer Jobs in Minnetonka, MN at Boston Scientific Corporation
Carolina Precision Technologies (CPT) is a premier, full-service precision manufacturer for the medical and aerospace industries. We are a market leading manufacturer of implants, specialty surgical instruments, cutting tools, and delivery systems for the orthopedic, sports medicine, trauma, extremities and other MedSurg applications. Our Putnam, CT location is looking for a detail-oriented Quality Technician who will be responsible for the highest quality of products manufactured by Carolina Precision by performing inspections against customer supplied and internally stated requirements, while working competently and in a timely manner.
Responsibilities and Duties
Conduct inspections per customer mandated validation requirements as directed
Perform first article inspections, in-process inspection points, and final quality inspections to ensure conformance to customer requirements provided through blueprints and control documents prior to product release
Perform raw material and product receiving activities from outside services/suppliers as needed
Develop/Suggest changes to current inspection procedures and work instructions in order to continuously improve and streamline the inspection processes
Conduct reworks and re-inspections as directed for nonconforming product found in-house or returned from customers as directed
Assist in root cause and corrective action determination in conjunction with other members of the Quality department to ensure completeness and effectivity of all assigned actions
Perform all required tasks in a timely manner
Provide QA support as designated by Quality Management
Report non-conformities as per documented process and coordinate accordingly with Quality Management
Communicate all quality issues to management in a timely manner, along with recommendations for any corrective or preventive actions that may be necessary
Minimum Requirements
Must be 18 years old
High School diploma or GED preferred
Familiarity with ISO 9001, ISO 13485, and FDA 21CFR Part 820 requirements
Familiarity of AQL inspection methods
Ability to utilize all inspection tools including calipers, micrometers, comparators, CMM etc.
3-14 years on the job experience in related field
Must possess organizational ability in order to set priorities, organize workload, and meet deadlines
Experience with 3-dimensional inspection and measurements
Excellent visual inspection skills and an eye for detail
QA experience in medical devices
Good knowledge and understanding of engineering drawing interpretation with GD&T specified features
Excellent record-keeping documentation and organizational skills
Ability to use ERP systems (Preferably VISUAL)
Able to bend, stoop, twist, reach, lift 40 pounds and stand on feet for an extended period of time
Benefits
Competitive salary including a full range of health benefits, paid time off, 401k with immediate vesting. Pay will be based on experience.
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Title: Sr Design Quality Assurance Engineer
Company: Boston Scientific Corporation
Location: Minnetonka, MN
