Quality Engineer II — CAPA, Compliance & Process QA

VIVA USA Inc; Saint Paul (MN); On-site; USD 85,000 - 120,000; Full time

Job summary

VIVA USA Inc. seeks a Quality Engineer II to assure products, processes and quality records meet quality standards and client quality system compliance. You will protect patient safety, collaborate with multifunctional teams, and support regulatory communications.

Responsibilities include nonconformance handling, CAPA and complaint investigations, data trend analysis, and QA procedure enhancements while navigating FDA and ISO requirements. On-site Plymouth, with occasional travel.

Qualifications

• Bachelor’s degree in Engineering, Technical Field, or equivalent.
• 2-5 years technical experience in QA/engineering.
• Experience with quality tools and methodologies.
• Strong communication and interpersonal skills.

Responsibilities

• Follows regulations and standards for quality, EHS&E, and client governance areas.
• Implements and maintains the Quality System effectiveness.
• Identifies risk related to internal and external compliance requirements.
• Completes Non-conformance, CAPA and complaint investigations with clear options and tradeoffs.
• Influences partners to develop QA procedures, forms, and systems.
• Leads QA system information meetings and updates.

Skills

Communication skills

Teamwork

Data analysis

Problem solving

Attention to detail

Multitasking

Education

Bachelor’s degree in Engineering/Technical Field

Advanced degree preferred

Tools

Excel

Statistical software

Quality tools/methodologies

Job description

VIVA USA Inc. seeks a Quality Engineer II to assure products, processes and quality records meet quality standards and client quality system compliance. You will protect patient safety, collaborate with multifunctional teams, and support regulatory communications.

Responsibilities include nonconformance handling, CAPA and complaint investigations, data trend analysis, and QA procedure enhancements while navigating FDA and ISO requirements. On-site Plymouth, with occasional travel.