Junior Quality Engineer
Plymouth, Minnesota | Medical Device Industry
We are seeking a Junior Quality Engineer for a very important client.
POSITION SUMMARY:
Assures compliance to external, FDA, ISO, and internal Quality Standards for product development and manufacturing. Creates and applies policies and procedures for identifying, analyzing and controlling risk throughout the product life cycle. Conducts evaluations, tests and makes decisions to maintain Quality objectives Designs and installs quality process sampling systems, procedures and statistical techniques.
Conducts training and supervises other engineers and inspection personnel in execution of Quality tasks Promotes success through development of methods and arguments for achieving company objectives while adhering to Quality/Regulatory requirements
PRINCIPAL ACCOUNTABILITIES:
Actively represent Quality Assurance function on product/process development teams. Hands on participant in early stages of product development including but not limited to physician interaction, product Engineering, competitive product testing, and prototype testing.
Participate in development, review and approval of test protocols and reports Interact with component suppliers on quality issues Establish, implement, and validate inspection plans, equipment and procedures Lead and participate on internal and external audit teams. Design and conduct testing for products, packages, shelf life studies, sterilization and process validations. Conduct capability studies for production processes.
The ideal candidate will possess the following skills:
EXPERIENCE:
Basic reading and math Reading drawings Computer literate; use of word processing, spreadsheets Quality System Requirements ISO procedures 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 Understanding of sterilization techniques Risk analysis technique, FMEA, Fault tree, Hazard Analysis Understanding of design of experiments
EDUCATION:
Bachelor of Science degree in Engineering, Experience in quality assurance in the medical device industry. nice to have but not a must Experience in vascular devices, embolic coils, stents, catheters, balloons, aspiration devices, guide wires, and/or syringes a plus. nice to have but not a must
JOB COMPETENCIES:
Physical Requirements: standing, sitting, walking, stairs, light lifting, computer operations, manual dexterity, hand/eye coordination, working on parts while looking through a microscope, direct exposure to health and safety hazards associated with production material and equipment, and travel by air/auto/rail. Preparation of data analyses and recommendation for actions.
Conduct product investigations, root cause analysis, and implementation of corrections and preventative actions. Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices. Training relative to Company requirements and procedures and individual job duties will be provided as outlined on the attached Training Requirements form. A training file containing documentation of all training received is maintained for each employee.
