Overview
Quality Engineer Jobs in Fort Wayne, Indiana, USA at Jobot Inc.
This range is provided by Jobot. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
$65,000.00/yr – $85,000.00/yr
Direct Hire Opportunity with Full Benefits. Come join our growing organization.
This Jobot Job is hosted by Brooke Meyer.
Salary: $65,000 – $85,000 per year
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
PTO
Job Details
Job Overview:
You will be responsible for the overall development, implementation, and maintenance of the organization’s ISO  and ISO  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 Â 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.
Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
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Title: Quality Engineer
Company: Jobot Inc.
Location: Fort Wayne, Indiana, USA
Category: Quality Assurance – QA/QC (Quality Control / Manager, QA Specialist / Manager, Quality Technician/ Inspector, Quality Engineering)
