Regional Lead Quality Engineer - Medical Devices/Combo

CSL Vifor; Waltham (MA); On-site; USD 143,000 - 169,000; Full time

Job summary

CSL Vifor in Waltham, MA seeks a Regional Lead Quality Engineer CP/MD to steer product development compliance with 21 CFR Part 4 and ISO standards, guiding CP/MD staff and coordinating with global functions.

The role emphasizes design controls, risk management, and V&V across the product lifecycle, with travel as needed and collaboration with internal and external teams to ensure high quality medical device products.

Qualifications

• Minimum 5 years in quality, packaging, engineering or manufacturing in medical devices or combination products.
• Strong knowledge of FDA 21 CFR Part 4, ISO 13485, ISO 14971 and EU MDR.
• Experience with design controls, risk management (FMEA) and V&V.
• Excellent communication and stakeholder influence abilities.

Responsibilities

• Provide clear Quality guidance to CP/MD development projects and ensure alignment with regulatory requirements.
• Oversee external partners with audits and quality agreements; monitor vendor performance.
• Report progress and escalate risks to Quality management and stakeholders.
• Drive improvements to quality systems, update SOPs/WIs and train staff.

Skills

Quality management

Design controls

Risk analysis

Statistical methods

Vendor audits

Six Sigma

Education

Bachelor's degree in mechanical or biomedical engineering

Tools

QMS software

Statistical software (e.g., Minitab)

Job description

CSL Vifor in Waltham, MA seeks a Regional Lead Quality Engineer CP/MD to steer product development compliance with 21 CFR Part 4 and ISO standards, guiding CP/MD staff and coordinating with global functions.

The role emphasizes design controls, risk management, and V&V across the product lifecycle, with travel as needed and collaboration with internal and external teams to ensure high quality medical device products.