Senior QA Engineer - QMS Remediation (Medical Devices)

Mykelly; North Billerica (MA); Vor Ort; USD 76.000 - 117.000; Vollzeit

Zusammenfassung

Kelly Science is seeking a Senior Quality Assurance Engineer for a contract-to-hire opportunity with a leading medical diagnostics company in Billerica, MA. This role emphasizes hands-on QMS remediation, regulatory compliance, risk management, and quality systems improvement within a highly regulated medical device environment, with a path to Design Assurance and NPD as remediation progresses.

The position requires onsite work 4-5 days per week and collaboration across Quality, Regulatory

Qualifikationen

• Bachelor's degree required in engineering, science, or related technical field.
• Minimum of 4 years of Quality Engineering experience in FDA-regulated medical device manufacturing.
• Hands-on experience with QMS remediation, quality system improvements, and regulatory compliance initiatives.

Aufgaben

• Lead QMS remediation initiatives, identify compliance gaps, implement corrective actions, and ensure sustainable audit findings resolutions.
• Assess, revise, and improve quality processes to ensure FDA and ISO compliance.
• Support internal/external/regulatory audits including responses and CAPA effectiveness verification.
• Drive CAPA, nonconformance management, change control, document control, and risk management process improvements.
• Perform risk management activities including FMEAs and risk analyses.
• Collaborate with Quality, Regulatory, R&D, Manufacturing, and Operations to close quality gaps.
• Review and improve quality documentation within a paper-based QMS environment.
• Support root-cause investigations and CPAs.
• Provide Design Assurance support for product development and changes.

Kenntnisse

QMS remediation

Regulatory compliance

CAPA & investigations

Design Controls

Risk management

FDA compliance

Documentation skills

Cross-functional collaboration

Ausbildung

Bachelor's degree in Engineering or related field

Tools

MS Office Suite

Jobbeschreibung

Kelly Science is seeking a Senior Quality Assurance Engineer for a contract-to-hire opportunity with a leading medical diagnostics company in Billerica, MA. This role emphasizes hands-on QMS remediation, regulatory compliance, risk management, and quality systems improvement within a highly regulated medical device environment, with a path to Design Assurance and NPD as remediation progresses.

The position requires onsite work 4-5 days per week and collaboration across Quality, Regulatory