CAPA Engineer

Novozen Healthcare LLC; Utah; On-site; USD 90,000 - 120,000; Full time

Job summary

Novozen Healthcare LLC is seeking a CAPA professional to support medical device CAPA processes and compliance, including completion of outstanding CAPA investigations and reporting. You will own CAPA cases from initiation through closure, accelerate CAPA processing, and support Quality System updates and modifications in a fast-paced manufacturing environment in Utah.

7+ years of medical device quality experience with strong CAPA, RCA, and NCR background are required.

Qualifications

• 7+ years of relevant medical device quality experience, including substantial experience at the Quality Engineer level.
• Strong CAPA, Root Cause Analysis, and NCR experience for interventional medical device and delivery systems manufacturing or Class III (Cardiovascular)

Responsibilities

• CAPA ownership and CAPA processing
• CAPA process acceleration
• Support Quality System updates and modifications

Skills

CAPA

Root Cause Analysis

NCR experience

Job description

CAPA professional needed to support medical device industry CAPA processes and compliance, and completion of outstanding CAPA investigations and reporting

DUTIES & RESPONSIBILITIES

• CAPA ownership and CAPA processing
• CAPA process acceleration
• Support Quality System updates and modifications

QUALIFICATIONS & REQUIREMENTS

• 7+ years of relevant medical device quality experience, including substantial experience at the Quality Engineer level
• Strong CAPA, Root Cause Analysis, and NCR experience for interventional medical device and delivery systems manufacturing or Class III (Cardiovascular)