Sr. Engineer, Quality - Allografts

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

Overview

Plans and conducts activities concerned with quality control, quality assurance and compliance of allograft processing.

Responsibilities

• Adheres to Good Tissue Practices established by FDA 1271 part 20, AATB Standards, EU GMP Annex I as well as quality/company objectives (goals) and corporate policies.


• Creates and updates procedures for the Allograft QMS that meet regulatory requirements.


• Completes deviations and CAPAs by providing a report that includes root cause, correction and corrective action.


• Analyzes and reports quality system and product specific data (trending) to the quality and processing team.


• Audits QMS and allograft processing to confirm compliance with procedures used and regulatory requirements.


• Updates the quality system based on non-conformities found during internal and external audits.


• Completes product and process validation, re-validation work which includes equipment and aseptic processing.


• Trains personnel to aseptic techniques and contamination control.


• Leads product and process risk evaluations.


• Applies statistical techniques to product and process.


• Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data.


• Performs review and evaluation of supplier quality information to qualify the vendors.


• Completes product complaint investigation and initiation of any corrections or corrective actions.


• Manages and improves assigned areas within the Quality Management System (QMS) including SOPs, work instructions, inspections.


• Provides support during QMS audits.


• Adheres to company policies, procedures, and documentation requirements.


• Treats others with courtesy, sensitivity, and respect at all times.


• Other duties as assigned.

Qualifications

Bachelors’ degree in either Biology, Microbiology, Chemistry, Chemical Engineering, Mechanical Engineering, or Biomedical Engineering required

6 years’ related experience

Knowledge of biologics/tissue processing preferred

Microsoft Office.

Fluent in English.

EEO Statement

In order to provide equal employment and advancement opportunities to all individuals, employment decisions at LeMaitre Vascular will be based on merit, qualifications, and abilities. LeMaitre Vascular does not discriminate in employment opportunities or practices on the basis of race, color, religion, sex, national origin, age, disability, sexual orientation, gender identity, breastfeeding or related medical conditions, religious dress, military or veteran status or any other characteristic protected by law.

This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination, and access to benefits and training.

Applicants with disabilities may contact LeMaitre HR coordinators via telephone, fax, e-mail, and other means to request and arrange for accommodations. If you need assistance to accommodate a disability, you may request an accommodation at any time. Please contact LeMaitre HR at [e-mail].