Medical Device Compliance & Quality Specialist

Katalyst-Healthcares-; Sunnyvale (CA); On-site; USD 85,000 - 130,000; Full time

Job summary

Fives DyAG Corp. in Sunnyvale, CA seeks a Compliance Specialist to support quality and regulatory activities in the medical device field, interpreting global regulations and aiding the QMS.

You will participate in CAPA and corrective actions, internal/external audits, and cross-functional collaboration with Quality, Regulatory Affairs, Engineering, and Manufacturing to ensure regulatory readiness and continuous improvement.

Qualifications

• 2–3+ years of experience in quality, compliance, regulatory affairs, or related function in medical device industry.
• Strong understanding of QMS and medical device quality processes.
• Bachelor's degree in engineering, Physical Science, Biological Science, Life Sciences, or a related technical field.

Responsibilities

• Support development, implementation, and maintenance of quality and regulatory compliance processes.
• Interpret applicable medical device regulations and provide guidance to teams.
• Assist with CAPA, audit readiness, and continuous improvement activities.
• Collaborate with Quality, Regulatory Affairs, Engineering, Manufacturing, and Operations to ensure compliance.

Education

Bachelor's degree in engineering or related technical field

Equivalent combination of education, training, and relevant experience

Job description

Fives DyAG Corp. in Sunnyvale, CA seeks a Compliance Specialist to support quality and regulatory activities in the medical device field, interpreting global regulations and aiding the QMS.

You will participate in CAPA and corrective actions, internal/external audits, and cross-functional collaboration with Quality, Regulatory Affairs, Engineering, and Manufacturing to ensure regulatory readiness and continuous improvement.