Manufacturing Quality Engineer – Medical Devices

AMD Warsaw LLC; Warsaw (IN); On-site; USD 70,000 - 100,000; Full time

Job summary

AMD Warsaw LLC in Warsaw, IN seeks a Manufacturing Quality Engineer (MQE) to understand customer quality requirements and drive root cause and quality improvements in inspecting medical parts.

The MQE will lead corrective actions, apply metrology and GD&T, develop control and sampling plans, and support APQP/PPAP for product launches while ensuring ISO 13485 and FDA QSR compliance alongside production teams.

Qualifications

• Previous Medical Device experience in a quality role is preferred but not required.
• Thorough knowledge of ISO 9001 and ISO 13485 standards and FDA 21 CFR part 820.
• Minimum Bachelor’s Degree in an Engineering or Science discipline.

Responsibilities

• Leads corrective and preventive actions and effectiveness verification activities for product quality issues.
• Applies knowledge of metrology and GD&T to develop inspection and test methods for a wide array of products and processes.
• Researches novel metrology approaches where necessary to support new or existing processes.
• Develops control plans and sampling plans for process control or validation for attribute and variable data.
• Understands APQP and PPAP processes and can apply related tools to complete or lead teams in product launch activities.
• Understands and applies statistical concepts including hypothesis testing, capability analysis, and other methods based on distributions.
• Works closely with production line to ensure controls are compliant with ISO 13485 and FDA QSR requirements.
• Develops/Uses KPIs and statistical methods to determine process effectiveness and drive continuous quality improvement.
• Prepares reports by collecting and analyzing data to identify trends and recommend updates to the Quality System.
• Ensures quality reporting and records are documented and maintained.
• May conduct internal audits and other quality system functions as assigned.
• Establishes and participates in supplier qualification/development activities.
• Contributes to other team efforts to meet business goals.

Skills

Interpersonal skills

Presentation skills

Technical writing

Quality control

Education

Bachelor's degree in Engineering or Science

Job description

AMD Warsaw LLC in Warsaw, IN seeks a Manufacturing Quality Engineer (MQE) to understand customer quality requirements and drive root cause and quality improvements in inspecting medical parts.

The MQE will lead corrective actions, apply metrology and GD&T, develop control and sampling plans, and support APQP/PPAP for product launches while ensuring ISO 13485 and FDA QSR compliance alongside production teams.