CAPA Engineer

Redbock - an NES Fircroft company; Utah; On-site; USD 90,000 - 120,000; Full time

Job summary

Redbock - an NES Fircroft company is seeking a CAPA professional to support the medical device CAPA processes and compliance, and to complete outstanding CAPA investigations and reporting.

Responsibilities include CAPA ownership, process acceleration, and supporting Quality System updates. The role requires extensive experience in CAPA, RCA, NCR, and a strong understanding of regulatory requirements in the medical device industry.

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 manufacture.
• CAPA ownership experience, and experience guiding and coaching others in CAPA procedures and process.
• Strong understanding of medical device industry Quality Systems, quality and regulatory requirements and guidelines.
• Excellent written, verbal, and interpersonal communication skills, including strong technical writing ability.

Responsibilities

• CAPA ownership and CAPA processing.
• CAPA process acceleration.
• Support Quality System updates and modification.

Skills

CAPA ownership

Root Cause Analysis

NCR experience

Medical device quality

Regulatory knowledge

Technical writing

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 modification

QUALIFICATIONS & REQUIREMENT

• 7+ years of relevant medical device quality experience, including substantial experience at the Quality Engineer lev
• Strong CAPA, Root Cause Analysis, and NCR experience for interventional medical device and delivery systems manufacture
• CAPA ownership experience, and experience guiding and coaching others in CAPA procedures and process
• Strong understanding of medical device industry Quality Systems, Quality and Regulatory requirements and guidelines
• Excellent written, verbal, and interpersonal communication skills, including strong technical writing ability

LOCATION: Work will be performed onsite in the greater Salt Lake City a