What are the responsibilities and job description for the Sr. Quality Engineer II position at Ledgent Technology?
Job Details
This Sr. Quality Engineer II will apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and systems/procedures to optimize product design, internal and external device manufacturing, and device distribution. Furthermore, this Quality Engineer will coordinate and perform complaint investigations as well as DMR/DHR changes in support of clinical inventory.
How you will make an impact:
* Support areas of Quality Assurance, Design Controls, Risk Management, Manufacturing Controls, and Statistical Techniques for New Product Development (NPD) programs
* Investigate complex manufacturing product quality and compliance issues reported from the field, analyze results, determine root cause/probable cause, and initiate and review reports.
* Coordinate and execute change control activities to support rapid innovation
* Support design and development activities (i.e., engineering study, feasibility testing, drawing review, etc.)
* Participate in escalation tasks and activities, including Project Risk Assessments (PRA)
* Supports or leads test method development/validation activities for Design Verification testing and manufacturing inspections for NPD programs
* Collaborate with R&D and Manufacturing organizations to facilitate the successful execution of the NPD process and launching of robust products
* Develop complex experiments and tests (including writing and executing protocols) to create, improve, and validate products and manufacturing processes by analyzing results, making recommendations, and developing reports
* Develop, update, and maintain technical content of risk management files
* Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes
* Assign and oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work
* Other incidental duties assigned by Leadership
* Ability to travel up to 10% domestically and internationally
What you'll need (Required Qualifications):
* Bachelor's degree in Engineering with a minimum of (4) years of experience in either NPD, Quality Engineering, R&D, and/or Manufacturing; OR a master's degree in engineering or Scientific field with internship, senior projects, or thesis experience required.
* Engineering experience within a highly regulated industry
What else we look for (Preferred Qualifications):
* Experience in medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment preferred.
* Knowledge and experience within Design Assurance, including Design Controls, Design Verification & Validation, Test Method Development, and Process Validation
* Experience with root cause analysis or investigations for Complaints, NCRs, and/or CAPAs.
* New Product Development experience from initial concept to commercialization (Class III preferred).
* Experience with Risk Management and Design Control
* Proven expertise in usage of MS Office Suite including MS Excel, Power Point, and WordProject
* Experience with using Adobe Acrobat
* Basic understanding of statistical techniques
* Strong problem-solving, organizational, analytical, and critical thinking skills
* Self-project management and tracking of deliverables with various participants and stakeholders
* Strong communication skills across various cross-functional groups and levels
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All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county, to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.
