Senior Quality Assurance Engineer

1 month ago


Wauwatosa, Wisconsin, United States Agiliti Health, Inc. Full time
Job Summary:

The Senior Supplier Quality Engineer will be responsible for developing and maintaining supplier quality management practices that meet Agiliti's requirements. This role will participate in all applicable Quality Management System (QMS) activities, including document change management, records management, training, non-conforming material reports, and corrective and preventive actions.

Key Responsibilities:

Participate in QMS activities, including document change management and records management.
Develop and maintain supplier quality management practices that meet Agiliti's requirements.
Participate in supplier new product qualification and supplier development processes.
Execute tasks associated with continuous improvement activities.
Provide data for predefined metrics for supplier monitoring.
Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
Ensure compliance with internal and external regulatory agencies.
Facilitate accurate and timely completion of customer and quality records.
Ensure that supplier corrective measures meet acceptable standards.
Apply statistical methodologies to assess and resolve potential product and quality system issues.

Requirements:

Bachelor's degree in Engineering or life sciences required.
Minimum 8 years Quality Engineering experience or advanced degree with 5 years of applicable experience.
Experience with ISO 13485, 21 CFR Part 820, and Medical Device Good Documentation Practices.
Experience guiding and coaching others.
3+ years of experience leading supplier quality management and new product development projects.
Experience improving and maintaining an effective Quality Management System.

Preferred Skills:

Proficient computer skills in MS Office Suite.
Comprehensive understanding of quality system requirements as stated within 21 CFR Part 820 and ISO 13485.
Strong analytical skills, including application of statistical techniques.
Strict attention to detail.
Strong technical writing skills and effective communication skills.
Strong presentation, facilitation, and project management skills.

Agiliti Health, Inc. is an equal opportunity employer and provides reasonable accommodations to employees and applicants consistent with state and federal law.

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