Quality Engineer – Medical Devices & Combination Products

Biopharma Careers; Waltham (MA); On-site; USD 94,000 - 111,000; Full time

Job summary

CSL Behring’s CP/MD QA team seeks an Associate Quality Engineer to support quality activities across global development, manufacturing, and regulatory approval of combination products. You’ll work under senior team guidance to ensure compliance with 21 CFR Part 4, ISO standards, and cross-functional collaboration in a fast-paced, matrix environment.

You will contribute to Design Controls, risk management, DHF maintenance, and CAPA execution while partnering with internal and external partners.

Qualifications

• Minimum 3 years of experience in a quality, engineering, manufacturing, or related technical role within medical device, pharmaceutical, biotechnology, medtech, or combination products industries.
• Working knowledge of 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ISO 14971, and EU MDR.
• Familiarity with Design Controls, risk management, V&V, and design transfer.

Responsibilities

• Serve as Quality Engineer on assigned combination product development projects as a Quality representative.
• Participate in Design Control activities and support risk management, document reviews, verification and validation planning, change management, and DHF maintenance.
• Collaborate with project leaders and both internal and external team members to ensure that all design development work meets applicable FDA, EU MDR and other global regulatory requirements.
• Ensure that design development teams follow the Design Controls process and utilize appropriate quality engineering techniques such as risk analysis, statistical data analysis, sampling plan development, etc.
• Assist with oversight of external development and manufacturing partners.
• Support vendor management activities by participating in the audits; reviewing quality or development agreements; monitoring vendor performance.
• Support maintenance and continuous improvement of combination product quality systems.
• As assigned, propose improvements to the existing processes, update SOPs / WIs / Forms, develop and conduct training on the modified processes.
• Identify and communicate quality-related issues and risks.
• Support investigations, CAPAs, nonconformance management, and change controls.
• Participate in internal audits and inspection readiness activities.
• Stay informed on applicable regulations and standards.
• Maintain quality-related systems and databases.

Skills

Quality engineering

Design Controls

Risk management

Regulatory knowledge

Education

Bachelor’s degree in mechanical or biomedical engineering, life sciences or relevant discipline

Job description

CSL Behring’s CP/MD QA team seeks an Associate Quality Engineer to support quality activities across global development, manufacturing, and regulatory approval of combination products. You’ll work under senior team guidance to ensure compliance with 21 CFR Part 4, ISO standards, and cross-functional collaboration in a fast-paced, matrix environment.

You will contribute to Design Controls, risk management, DHF maintenance, and CAPA execution while partnering with internal and external partners.