What are the responsibilities and job description for the Quality Engineer position at jobbot?
A bit about us :
We specialize in design, engineering and manufacturing of electronic products.
Why join us?
Opportunity for growth and advancement
Benefits
Collaborative work environment
Stability
401 K match
Job Details
Job Overview : You will be responsible for the overall development, implementation, and maintenance of the organization’s ISO 9001 : 2015 and ISO 13485 : 2016 certified Quality Management System (QMS). This role involves working closely with Procurement, Production, Engineering, and other departments to continually improve the quality of the organization’s products. You will also manage one direct report, the Quality Supervisor.
Responsibilities and Duties :
Ensure that the organization’s Quality Management System conforms to customer, internal, ISO 9001, ISO 13485, and regulatory / legal requirements.
Act as the management representative for the ISO 13485 : 2016 certified medical device manufacturing facility.
Lead and develop team members performing incoming, in-process, and final inspections.
Monitor and measure KPIs, turning raw data into dashboards, graphs, and reports.
Collaborate with customers, employees, and third-party engineers to develop product requirements.
Serve as the main point of contact for all audit discussions with second and third-party auditors.
Perform root cause analysis, develop action plans, and implement corrective and preventive actions (CAPA).
Report to top management on the performance of the QMS.
Conduct internal audits of all functional groups and continually improve the QMS.
Conduct periodic management review meetings.
Update procedures and execute document control and record keeping.
Manage all nonconforming raw materials and finished products.
Develop and implement Lean, 5S, Kaizen, and other tools with every department.
Oversee customer complaints, returned nonconforming products, and product recalls.
Stay updated on standards, regulations / laws, issues, and news related to product (service) quality.
Qualifications :
A Bachelor's degree and / or at least 5 years of experience in Quality Assurance / Quality Control is required.
Proficiency with MS-Office is essential.
Project management experience is a plus.
Occasional travel to vendor sites (5%) for audits, inspections, etc., may be required.
Previous experience managing an ISO 13485 compliant QMS is a plus.
Physical requirements include sitting for extended periods, using hands to handle objects, and occasional light lifting.
Skills :
Excellent communication skills and the ability to work well with people at all levels are essential.
Strong organizational, analytical, problem-solving, mathematical, and management skills are required.
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