Associate Quality Engineer, Combination Products

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

Job summary

CSL Behring in Waltham, MA seeks an Associate Quality Engineer to support CP/MD development and regulatory activities, ensuring compliance with FDA and EU MDR standards. You will work with global teams to maintain quality systems and DHF/DSF documentation.

Under supervision, you will participate in Design Controls, risk management, and V&V, assist audits, CAPAs, and supplier oversight, and contribute to continuous improvement of quality processes across sites.

Qualifications

• 3+ years in quality, engineering, manufacturing, or related role in medical devices or combination products.
• Knowledge of 21 CFR Part 820, Part 4, ISO 13485, ISO 14971 and EU MDR.
• Experience with Design Controls, risk management, V&V, and design transfer.
• Strong communication and collaboration skills; able to work cross-functionally.

Responsibilities

• Serve as Quality Engineer on CP/MD development projects and ensure regulatory compliance.
• Support audits, vendor management, and QMS maintenance.
• Assist in CAPAs, nonconformances, change controls, and investigations.
• Maintain DHF, quality systems, and related databases.
• Participate in internal audits and inspection readiness.
• Stay updated on applicable regulations and standards.
• Collaborate with cross-functional teams across sites.

Skills

Design Controls

Risk Analysis

Verification & Validation

CAPA

Audit Readiness

Vendor Management

Regulatory Compliance

Education

Bachelor's degree in mechanical or biomedical engineering

Job description

As a part of the Quality for Combination Products and Medical Devices (CP/MD QA) department, the Associate Quality Engineer will support Quality activities in global teams involved in the design, development, manufacture and regulatory approval of CSL Behring combination products. Under the guidance of senior Quality team members, this role supports quality oversight for combination product development activities to ensure compliance with applicable quality system requirements, including 21 CFR Part 4. The role collaborates with cross-functional teams and manufacturing sites to support compliant product development and maintenance activities. This role reports to: Regional Product Development Quality LeadPositions reporting into this role: This role has no direct reports Main Responsibilities and Accountabilities:

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 log

Education & 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.