Join Our Team
Electronic Design & Manufacturing (EDM) is a premier custom and contract manufacturing company. We specialize in the manufacturing of through-hole and surface mount circuit boards, electronic assemblies, and electro-mechanical assembly services. Our customers range from startups to Fortune 500 companies in all segments of industry with manufacturing, engineering design, service and warranty support, and full turnkey product fulfillment.
EDM is a subsidiary of Pivot International, a global single-source design, development, engineering, and manufacturing company headquartered in Lenexa, Kansas. Pivot, along with their companies, provide product development based in the United States and Europe while offering our customers the financial advantages of global tooling, procurement, and manufacturing at their facilities in the US, Europe, and Asia. We offer a unique suite of product design services with the expertise to deliver only the most effective solutions. We have enjoyed explosive growth in recent years and know that our employees are our most valuable resource and continue to be the driving force behind our success.
You’re welcome to send your resume and cover letter to us at careers@pivotint.com for consideration any time.
Quality Assurance Manager
EDM is part of Pivot International, a global single-source design, development, engineering, and manufacturing company with over 50 years of experience. Pivot provides product development based in the United States and Europe while offering their customers the financial advantages of global tooling, procurement, and manufacturing at their facilities throughout the US, Europe, Mexico, and Asia. Through the Pivot International group of companies, they offer a unique suite of product design services with the expertise to deliver the most effective solutions.
Job Objective:
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
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 ISO13485 compliant QMS is a plus
- While performing the duties of this job, the employee is regularly required to sit for extended periods of time, use hands to finger, handle, or feel objects, tools or controls; reach with hands and arms, and talk and hear.
- Standing, sitting, stooping and squatting can be expected along with light lifting of 20 lbs.
- Specific vision abilities required may include close vision, distance vision, peripheral and depth perception and ability to focus.
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
Location: La Vista, NE
