Quality Engineer

POSITION SUMMARY

The Quality Engineer II provides technical expertise and quality support for manufacturing process improvements and product lifecycle activities within the tissue banking and medical device industry. This position independently leads quality projects requiring validation or equipment qualification, ensuring compliance with FDA, AATB, and ISO 13485 regulations, and drives continuous improvement initiatives. The Quality Engineer II applies risk management, data analysis, and validation principles to enhance product quality, process robustness, and system effectiveness.

KEY RESPONSIBILITIES

The essential functions include, but are not limited to the following:

• Leads and performs software/process validations and equipment qualifications with guidance/support from Quality Engineering Management.

• Performs Quality review of data generated from software/process validations and equipment qualifications.

• Supports calibration and corrective/preventative maintenance programs for production equipment, test equipment, analytical equipment, and the facility within the eQMS.

• Support commissioning new equipment and decommissioning existing equipment inclusive of tag out activities required per procedure.

• Supports the change control system through performance of Validation assessments.

• Performs Validation reassessments and requalifies critical equipment based on established frequencies.

• Own and facilitate the execution and maintenance of environmental continuous monitoring system.

• Lead and document 3rd party execution for Cleanroom recertification activities.

• Develop or revise Quality System procedures, Standard Operation procedures, Work Instructions and Forms.

• Perform and document investigations for deviations and CAPA as applicable in a timely manner in accordance with Quality System procedures.

• Leads or participates in corporate or quality projects for continuous improvement and to identify potential quality issues.

• Supports product development and operations departments to ensure successful transition of products and processes from design to production by applying quality tools and methods.

• Perform statistical analysis and design experiments to support processing development, process control, and process improvement.

• Collect, analyze, and prepare key performance report data to management as applicable.

• Supports risk management activities in accordance with ISO 14971 and design control requirements.

• Support internal and external audits (FDA, ISO, AATB) and ensure compliance with quality and regulatory standards.

REQUIRED QUALIFICATIONS

• Bachelor's degree in a technical/relevant field, with at least five (5) years of Quality Assurance and related Validation experience in a pharmaceutical, medical device, biologic, or tissue banking FDA regulated facility; or an appropriate combination of education, certification and work experience

• Knowledge and understanding of regulatory requirements, including but not limited to 21 CFR 1271, AATB, ISO 13485, cGTP, cGMP, 21 CFR 820, 21 CFR 210 & 211, and other applicable state and federal regulations.

• Knowledge of IEC 62304 (FDA Software Validation), FDA quality systems regulation, and FDA 21 CFR part 11.

• Software/equipment/process/test method validation experience.

• Ability to support the regulatory team in writing, validating, and testing requirements.

• Experience with analytical and software validations and qualifications.

• Ability to represent Quality and Regulatory on multiple concurrent projects.

• Ability to identify Quality Management System (QMS) needs.

• Ability to support production and the production team.

PREFERRED QUALIFICATIONS

• Experience in ISO 13485

• ASQ Certification preferred

• Greenbelt (or higher) in Lean Six Sigma