Quality Engineer

Katalyst CRO; Tampa (FL); On-site; USD 120,000 - 160,000; Full time

Job summary

Katalyst CRO is seeking a Quality Engineer to develop and maintain quality engineering methodologies and practices across product development and manufacturing. The role acts as a quality representative to drive awareness and alignment with quality goals at multiple organizational levels.

The candidate will lead cross-functional quality initiatives, mentor engineers, and implement CAPA and process controls to ensure compliance with regulatory requirements and customer expectations.

Qualifications

• 5+ years with BS in a related field; 3–4 years with MS.
• Medical device experience is required or preferred.
• Coordination with contract manufacturers and cross-functional teams.
• Experience owning CAPA and post‑market surveillance activities.

Responsibilities

• Develops, establishes and maintains quality engineering methodologies, systems, and practices.
• Provides leadership to champion departmental or cross‑functional engineering initiatives.
• Mentors engineering staff and supports design changes and supplier quality activities.
• Leads investigation of quality issues using systematic problem solving.
• Implements process controls and CAPA systems to meet internal and external requirements.
• Supports quality operations for devices including hepatic artery infusion pump and accessories.

Skills

Quality engineering

Design Assurance

Operations Quality

Software Engineering

CAPA

Root cause analysis

Education

Bachelor's degree

Master's degree

Job description

• Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality engineering support within new product development, operational, or system/services support.
• Functional Engineering Roles include: Design Assurance, Operations Quality, Software Engineering, Supplier Assurance, Product Analysis, Metrology, Microbiologist, Chemist
• Provides leadership role on championing departmental or cross-functional engineering initiatives.
• Provides project direction, coaching, and mentoring for engineering and technical team personnel.
• Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
• Mentor for technical guidance for identifying and resolving quality issues.
• Identifies and implements effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
• Leads in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
• Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Assures the development and execution of streamlined business systems which effectively identify and resolve quality issues.

Summary

• Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality engineering support within new product development, operational, or system/services support.
• Functional Engineering Roles include: Design Assurance, Operations Quality, Software Engineering, Supplier Assurance, Product Analysis, Metrology, Microbiologist, Chemist

Roles & Responsibilities

• Provides leadership role on championing departmental or cross-functional engineering initiatives.
• Provides project direction, coaching, and mentoring for engineering and technical team personnel.
• Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
• Mentor for technical guidance for identifying and resolving quality issues.
• Identifies and implements effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
• Leads in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
• Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Assures the development and execution of streamlined business systems which effectively identify and resolve quality issues.

Requirements

• 5+Years with BS, 3 -4 Years with MS
• Ability to take work direction and work independently
• Medical device experience
• coordination and ownership, communicating with the contract manufacturer and BSC Quality/operations/design teams, supporting design changes activities and supplier corrective records, etc. CAPA Primary work assignments will be involving supporting our Quality systems and Quality operations for our hepatic artery infusion pump and accessories authoring post market surveillance report, periodic document reviews,
• experiencePost market surveillance
• Experience owning CAPA
• Root cause analysis experience