Associate Quality Engineer, Combination Products

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

Job summary

CSL Vifor in United States, Massachusetts, seeks a Quality Engineer to serve as the QA representative on combination product development projects. You will participate in Design Controls, support risk management, reviews, V&V planning, change control, and DHF maintenance, ensuring compliance with FDA, EU MDR and other global regulations.

The role requires at least 3 years in quality, engineering, manufacturing, or related technical work within medical devices or biotechnology, with working

Qualifications

• Bachelor’s degree in mechanical or biomedical engineering, life sciences, or a related discipline.
• Minimum 3 years of experience in quality, engineering, manufacturing, or related technical role within medical device, pharmaceutical, biotechnology, medtech, or combination products.
• 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 abilities.
• Ability to work independently on routine assignments while seeking guidance on complex issues.

Responsibilities

• Serve as Quality Engineer on assigned combination product development projects as a Quality representative.
• Participate in Design Controls activities and support risk management, document reviews, verification and validation planning, change management, and DHF maintenance.
• Collaborate with project leaders and internal/external team members to ensure design development work meets regulatory requirements.
• Ensure design development teams follow Design Controls and utilize quality techniques such as risk analysis and sampling.
• Assist with oversight of external development and manufacturing partners; participate in audits and review QA agreements.
• Support maintenance and improvement of quality systems; update SOPs/WI; train on 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 (vendor certificates, test method validation log).

Skills

Quality engineering

Regulatory compliance

Design Controls

Risk management

Documentation reviews

V&V planning

Change management

Analytical skills

Cross-functional collaboration

Independent work

Education

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

Job description

This role reports to:

Regional Product Development Quality Lead

Positions reporting into this role:

This role has no direct reports

Main Responsibilities and Accountabilities:

• 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. 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. 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. Identify and communicate quality-related issues and risks.
• 5. Support investigations, CAPAs, nonconformance management, and change controls.
• 6. Participate in internal audits and inspection readiness activities.
• 7. Stay informed on applicable regulations and standards.
• 8. Maintain quality-related systems and databases. Examples may include Applicable Standards List, vendor certificate database, test method validation log

Education & Experience

• Bachelor’sdegreein mechanical orbiomedical engineering,lifesciences 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.