Quality Systems Engineer — CAPA & Audit Lead

Regulatory Jobs; Andover (MA); In loco; USD 70.000 - 110.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical with Health Reimbursement

Dental

Vision

Flexible Spending Account

Dependent Care Flexible Spending

Short Term Disability

Long Term Disability

401K Plan

Pet insurance

Employee Stock Purchase Plan

Descrizione del lavoro

TransMedics is seeking a dynamic QA professional to join the Quality team, focusing on Quality Systems, CAPA, internal audits, metrics reporting, and process improvement. The ideal candidate has medical device or IVD experience and a solid background in QMS.

This four-month assignment supports CAPA activities, audits, data analysis, and cross-functional quality initiatives. You will help maintain compliance with 21 CFR Part 820, ISO 13485, and EU MDR while driving efficiency and continuous

Competenze

• Bachelor’s degree in Engineering, Biomedical Science, or related field with 5–7 years in medical devices.
• Knowledge of QMS standards (21 CFR Part 820, ISO 13485, EU MDR).
• Ability to multi-task and manage shifting priorities in a fast-paced environment.
• Experience creating and documenting procedures and processes.
• Results-driven with sense of urgency and strong analytical skills.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint, Access).

Mansioni

• Support QMS processes, CAPA, and audits; manage records and metrics.
• Coordinate CAPA activities, provide input to investigations and trending.
• Support Risk Management, FMEA, and quality plans.
• Develop and manage Quality Control/Quality System improvements.
• Provide training on quality processes across the organization.
• Prepare data for monthly metrics meetings and Management Reviews.
• Assist with external audits and inspections.

Conoscenze

Quality Systems

CAPA

Internal Audit

Quality Metrics

Formazione

Bachelor’s Degree in Engineering, Biomedical Science, or related field

Strumenti

Microsoft Office

Descrizione del lavoro

TransMedics is seeking a dynamic QA professional to join the Quality team, focusing on Quality Systems, CAPA, internal audits, metrics reporting, and process improvement. The ideal candidate has medical device or IVD experience and a solid background in QMS.

This four-month assignment supports CAPA activities, audits, data analysis, and cross-functional quality initiatives. You will help maintain compliance with 21 CFR Part 820, ISO 13485, and EU MDR while driving efficiency and continuous