Associate Quality Engineer, Combination Products

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

Job summary

CSL Plasma is seeking a Quality Engineer to join our combination product development projects as a quality representative. You will participate in Design Controls, support risk management, verification/validation planning, change management, and DHF maintenance, ensuring compliance with FDA, EU MDR and other global requirements.

Collaborate with project leaders and internal/external teams to ensure development work meets regulatory standards; apply quality engineering techniques such as risk

Qualifications

• Bachelor’s degree in mechanical or biomedical engineering or life sciences.
• Minimum 3 years in quality, engineering, manufacturing, or related technical roles in medical device or combination products.
• Working knowledge of 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ISO 14971 and EU MDR.

Responsibilities

• Serve as Quality Engineer on combination product development projects and participate in Design Control activities.
• Assist with oversight of external development and manufacturing partners and vendor audits.
• Support maintenance and continuous improvement of quality systems and SOPs.
• Identify and communicate quality issues and risks.
• Support investigations, CAPAs, nonconformance management, and change controls.
• Participate in internal audits and inspection readiness.
• Stay informed on applicable regulations and standards.
• Maintain quality-related systems and databases.

Education

Bachelor’s degree in mechanical or biomedical engineering

Job description

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’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.

Salary and Compensation

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.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement. CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please click here.

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