Quality Assurance Manager

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 Summary

The Quality Assurance Manager is 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 product.

Responsibilities

• 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 KPIs and turn raw data into dashboards, graphs, and reports.
• Work with customers, employees, and 3rd party engineers to develop product requirements.
• Receive all 2nd and 3rd party auditors and perform as the main point of contact 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.
• 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.

Join our team as a Quality Assurance Manager 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