Process Engineering Supervisor - Diagnostics Manufacturing

RXinsider LTD.; Scarborough (ME); On-site; USD 78,000 - 156,000; Full time

Job summary

Abbott Rapid Diagnostics is seeking an Engineering Supervisor Process Engineering in Scarborough, ME. Lead a team of process engineers to support manufacturing, with focus on quality, process validation, and continuous improvement.

You will drive CAPA activities, collaborate with Quality and Operations, and ensure documentation accuracy across SOPs and records in a regulated environment.

Qualifications

• Bachelor’s degree in Engineering required.
• 5+ years of manufacturing/process engineering within a regulated industry.
• Knowledge of FDA, ISO 13485, GMP and quality systems.
• Proven leadership, mentoring and team performance driving experience.
• Experience with process validation (IQ/OQ/TMV/PQ) and equipment qualification.

Responsibilities

• Lead and develop a team of process engineers and technicians to support daily manufacturing operations.
• Set priorities, monitor performance, and align with production goals and quality standards.
• Coach and mentor for continuous skill development within the team.
• Design, control, and improve manufacturing processes for diagnostic product production.
• Ensure validation documentation meets FDA/ISO requirements and maintains state of control.

Skills

Leadership

Team Development

Problem Solving

Cross-functional Collaboration

Data-driven Decisions

Quality Compliance

Communication

Process Validation

Lean Six Sigma

Education

Bachelor’s degree in Engineering

Tools

Minitab

JMP

DOE

Job description

Abbott Rapid Diagnostics is seeking an Engineering Supervisor Process Engineering in Scarborough, ME. Lead a team of process engineers to support manufacturing, with focus on quality, process validation, and continuous improvement.

You will drive CAPA activities, collaborate with Quality and Operations, and ensure documentation accuracy across SOPs and records in a regulated environment.