Quality Engineer - Manufacturing (Medical Device)

Quality Engineer - Manufacturing (Medical Device) at Beacon Hill Quality Engineer - Manufacturing (Medical Device) at Beacon Hill in Shakopee, Minnesota Posted in 3 days ago.

Type:

full-time

Job Description:

Quality Engineer - Manufacturing (Medical Device)

Location:

Shakopee, MN Job Type:

Contract?to?

Hire Job Overview We are seeking a Quality Engineer to support a manufacturing environment serving medical device customers . This role is hands?on and customer?facing, focused on quality engineering execution, continuous improvement, and compliance within a regulated production setting. The ideal candidate brings experience with

ISO 9001

, strong problem?solving skills, and the ability to work cross?functionally with manufacturing, engineering, and customers. Key Responsibilities Work directly with customers to address quality concerns, complaints, returns, and change requests Create, update, and maintain PFMEAs, control plans, and work instructions Troubleshoot and analyze internal manufacturing failures and nonconformances Lead and support corrective actions (CAPA) and MRB activities Assist with testing and validation activities Create and document quality records, including Major Quality Miscue (MQM) forms Analyze and report production and test data to identify trends and improvement opportunities Perform and support random inspections using standard inspection equipment (calipers, micrometers, etc.) Coordinate closely with manufacturing, engineering, and other internal teams Support continuous improvement initiatives to enhance product quality and reduce defects Follow all safety requirements and maintain a clean, organized work area Qualifications Bachelor's degree in Engineering or a related technical field 3+ years of experience in a manufacturing quality engineering role Experience supporting medical device or regulated manufacturing environments preferred Working knowledge of

ISO 9001

Quality Management Systems Hands?on experience with PFMEA, control plans, MRB, CAPA, SPC, and root cause analysis Familiarity with ERP systems (SAP or similar preferred) Ability to read and interpret engineering drawings and technical documentation Strong written and verbal communication skills Detail?oriented, organized, and able to manage multiple priorities Work Environment Primarily office?based with regular interaction on the manufacturing floor Occasional travel to customer or vendor sites