Quality Systems Engineer
MidQuality ManagementMedical DevicesUnknown
Market Rate — Compliance Officers
25th
$59K
Median
$76K
75th
$101K
BLS 2024 data (national)
Description
This position will report directly to the Quality Manager. This individual will work closely with the Quality and Engineering teams. This role will help support the development, implementation, and continuous improvement of the Quality Management System. Responsibilities include developing and implementing quality standards and quality control systems, writing procedures and processes for the QMS, monitoring quality performance, inspecting and testing materials and products, auditing systems and supply chain, creating and executing test scripts, and communicating with stakeholders. The role also involves providing training, participating in Quality reviews, supporting compliance filings, maintaining the eQMS, handling investigations and CAPAs, managing supplier interfaces, and supporting audits and inspections.
Requirements
A minimum of Associates Degree in Engineering or Business, or 2+ years of related technical experience. Experience or education in medical devices within related industries is a plus. Candidates should have knowledge of Quality Management Systems, application of ISO 13485 regulations, experience in supplier management, process development and validation principles, interpreting drawings and GD&T, and Change Control and CAPA applications. Candidates must demonstrate effective cross-functional skills, conflict resolution, and the ability to represent their department in project teams. Strong organizational, leadership, and communication skills are required, along with a willingness to travel to sister sites weekly.
NextStep Arthropedix
MEDICAL DEVICES
Hip Implant
LocationOH - Akron
Open Jobs6
UnknownMedical DevicesOrthopedics
View Company Profile