Senior Quality Engineer, Allograft Processing

LeMaitre Vascular; Burlington (MA); On-site; USD 100,000 - 150,000; Full time

Job summary

LeMaitre Vascular in Burlington, MA seeks a Quality Assurance Manager to oversee quality control, QA/QMS compliance, and regulatory alignment for allograft processing. You will create and update procedures, manage deviations and CAPAs, and lead risk assessments and audits with cross-functional teams.

The role requires a Bachelor’s degree in a relevant field, 6 years of related experience, and strong knowledge of biologics/tissue processing.

Qualifications

• Bachelor's degree in Biology, Microbiology, Chemistry, Chemical Engineering, Mechanical Engineering, or Biomedical Engineering is required.
• At least 6 years of related experience.
• Knowledge of biologics/tissue processing preferred.
• Proficient with Microsoft Office.
• Fluent in English.

Responsibilities

• Adheres to FDA 1271 part 20 and AATB standards and corporate policies.
• Creates and updates QMS procedures to meet regulatory requirements.
• Completes deviations and CAPAs with root cause and corrective action.
• Analyzes quality data and trends for the quality and processing team.
• Audits QMS and allograft processing for compliance with procedures and regs.
• Updates the quality system based on audit non-conformities.
• Completes product and process validation and re-validation work.
• Trains personnel in aseptic techniques and contamination control.
• Leads product and process risk evaluations.
• Applies statistical techniques to product and process data.
• Devises sampling procedures and data recording forms.
• Reviews supplier quality information to qualify vendors.
• Completes product complaint investigations and corrective actions.
• Manages and improves areas within the QMS including SOPs and work instructions.
• Provides support during QMS audits.
• Adheres to company policies and documentation requirements.
• Treats others with courtesy, sensitivity, and respect.
• Other duties as assigned.

Skills

Fluent English

Education

Bachelor's degree in Biology, Microbiology, Chemistry, Chemical Engineering, Mechanical Engineering, or Biomedical Engineering

Tools

Microsoft Office

Job description

LeMaitre Vascular in Burlington, MA seeks a Quality Assurance Manager to oversee quality control, QA/QMS compliance, and regulatory alignment for allograft processing. You will create and update procedures, manage deviations and CAPAs, and lead risk assessments and audits with cross-functional teams.

The role requires a Bachelor’s degree in a relevant field, 6 years of related experience, and strong knowledge of biologics/tissue processing.