Associate Quality Engineer, Combination Products

CSL Plasma; Waltham (MA); On-site; USD 94,000 - 111,000; Full time

Job summary

CSL Plasma in the United States is seeking a Quality Engineer to drive design controls, risk management, and DHF maintenance on combination product projects. You will participate in design reviews and ensure compliance with FDA, EU MDR and global regulatory requirements.

You will oversee external development and manufacturing partners, support vendor audits, and help maintain continuous improvement of quality systems.

Qualifications

• Bachelor's degree in mechanical or biomedical engineering, life sciences or relevant discipline.
• 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 design development projects and ensure regulatory compliance.
• Oversee external development and manufacturing partners and participate in audits.
• Maintain and improve quality systems; update SOPs/Forms and train on new processes.
• Identify and communicate quality-related issues and risks.
• Support investigations, CAPAs, nonconformance, and change controls.
• Participate in internal audits and inspection readiness.
• Stay informed on applicable regulations and standards.
• Maintain quality-related systems and databases.

Skills

Quality engineering

Design Controls

Risk management

Regulatory knowledge

Communication

Education

Bachelor's degree in mechanical or biomedical engineering

Job description

Main Responsibilities and Accountabilities

1. 1. 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.
2. 2 . 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.
3. 3 . 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.
4. 4 . Identify and communicate quality-related issues and risks.
5. 5 . Support investigations, CAPAs, nonconformance management, and change controls.
6. 6 . Participate in internal audits and inspection readiness activities.
7. 7 . Stay informed on applicable regulations and standards.
8. 8 . Maintain quality-related systems and databases. Examples may include Applicable Standards List, vendor certificate database, test method validation logEducation & Experience Bachelor's degree in mechanical or biomedical engineering, life sciences or relevant discipline. 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. Effective communication and collaboration skills. Strong organizational and planning skills. Analytical and problem-solving skills. Ability to work independently on routine assignments while seeking guidance on complex issues. Combination product or drug delivery device experience preferred but not required.

The expected base salary range for this position at hiring is $94,000 - $111,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.