Senior Quality Engineer — Medical Devices (FDA/ISO)

AMETEK, Inc.; Bridgeport (CT); On-site; USD 90,000 - 115,000; Full time

Job summary

AMETEK, Inc. under the Advanced Medical Components unit seeks a Senior Quality Engineer to ensure customers' requirements are met for surgical instruments, implants, or instrument delivery systems from receiving materials to finished goods shipping.

You will develop and enforce internal systems to meet ISO and FDA quality regulations, design inspection/validation steps, and implement new inspection equipment. Strong emphasis on SPC, CAPA, and continuous improvement in a manufacturing setting.

Qualifications

• 3–5 years of experience with tight tolerance measurement systems in machining.
• Familiar with ISO standards and FDA quality system regulations.
• Knowledge of DOE and short-run process control methods.

Responsibilities

• Develop and implement inspection/validation techniques to verify product conformance.
• Lead or verify CAPAs and support MRB and internal non-conformances.
• Implement SPC and monitor process capability; guide calibration and data recording.
• Lead training on new inspection equipment and processes.

Skills

written communication skills

project management

Minitab

Word

Excel

PowerPoint

Education

Bachelor's Degree in Engineering

Tools

Minitab

Microsoft Word

Microsoft Excel

PowerPoint

Job description

AMETEK, Inc. under the Advanced Medical Components unit seeks a Senior Quality Engineer to ensure customers' requirements are met for surgical instruments, implants, or instrument delivery systems from receiving materials to finished goods shipping.

You will develop and enforce internal systems to meet ISO and FDA quality regulations, design inspection/validation steps, and implement new inspection equipment. Strong emphasis on SPC, CAPA, and continuous improvement in a manufacturing setting.