Overview
Quality Engineering Technician Jobs in Warsaw, IN at Zimmer Biomet
Known today as Pivot-EDM, Inc., Electronic Design and Manufacturing (EDM) was founded in 1979 as a division of Nebraska Electronics Inc. to provide high quality electronics manufacturing in the Midwest. Over 40 years in business, EDM has grown to become a premier national ISO 9001:2015 and ISO 13485:2016 certified full-service custom and contract manufacturing company, specializing in the manufacture of electronic assemblies and through-hole and surface mount circuit boards.
We partner with customers on jobs with production runs ranging from a first prototype all the way up to full turnkey production with direct customer fulfillment services. EDM also offers a full engineering staff to better serve our customers’ needs for manufacturing, prototyping, circuit board layout, and electronic design and development.
Job Overview:
Responsible for overall development, implementation and maintenance of the organization’s ISO 9001:2015 and ISO 13485:2016 certified Quality Management System (QMS). Works in conjunction with procurement, production, engineering and every other department to continually improve the quality of the organization’s products. Has one direct report (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
Perform as the management representative for ISO 13485:2016 certified medical device manufacturing facility
Lead and develop team members performing incoming, in-process, and final inspections
Monitor and measure kpi’s and turn raw data into dashboards, graphs, and reports
Work with customers, employees, and 3rd part engineers to develop product requirements
Receive all 2nd and 3rd party auditors and perform as the main poc for all audit discussions
Perform root cause analysis, develop action plans, and implement 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 material and finished products
Develop and implement lean, 5s, Kaizen, and other tools with every department · oversee customer complaints, returned nonconforming product, and product recalls · keep up on standards, regulations/laws, issues, and news with respect to product (service) quality
Qualifications:
Bachelor’s degree and/or at least 5 years of experience in quality assurance/quality control is required
Experience 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
Skills:
Excellent communication skills and the ability to work well with people at all levels are essential.
Must have strong organizational, analytical, problem-solving, mathematical, and management skills.
Join our team as a Quality Engineer where you will play a crucial role in maintaining our commitment to product excellence and regulatory compliance!
Job Type: Full-time
Benefits:
401(k)
Dental insurance
Health insurance
Paid time off
Vision insurance
Schedule:
Monday to Friday
Ability to Relocate:
La Vista, NE 68128: Relocate before starting work (Required)
Work Location: In person
Title: Quality Engineering Technician
Company: Zimmer Biomet
Location: Warsaw, IN
