Quality Engineer I - Manufacturing Operations

Quality Engineer I – Manufacturing Operations

Bachelor’s Degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or related field.
Strong foundation in mechanical engineering principles.
Problem-solving skills.
Commitment to continuous improvement.

Support the development, validation, and maintenance of manufacturing equipment and tooling to meet quality and regulatory requirements.
Conduct root cause analysis and implement corrective and preventive actions (CAPAs) for process deviations and non-conformances.
Collaborate with cross-functional teams, including manufacturing, R&D, and regulatory affairs, to enhance product quality and process efficiency.
Assist in designing and executing test methods for mechanical components and systems to ensure compliance with Medtronic’s quality standards.
Participate in risk management activities, such as Failure Modes and Effects Analysis (FMEA) for equipment and tooling.
Support equipment qualification and validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Ensure adherence to FDA, ISO 13485, and other relevant regulatory and quality system requirements.
Document and analyze quality data to drive process improvements and operational excellence.

Internship or co-op experience in a medical device, pharmaceutical, or manufacturing environment.
Familiarity with CAD software for tooling and equipment design.
Knowledge of Six Sigma, Lean Manufacturing, and process improvement methodologies.
Experience with Good Manufacturing Practices (GMP) and regulatory compliance.
Strong analytical and problem-solving skills.
Ability to work collaboratively in a team environment.
Basic knowledge of quality systems, statistical analysis, and process validation.
Effective communication skills for documentation, reporting, and cross-functional collaboration.