Quality Engineer

Pentangle Tech Services | P5 Group; Minneapolis (MN); On-site; USD 90,000 - 130,000; Full time

Job summary

Pentangle Tech Services | P5 Group is seeking a seasoned Quality Management professional in the United States to advance medical device quality programs. You will apply CAPA, TMV, and process validation to ensure compliance and robust product quality across manufacturing processes.

You will collaborate with cross-functional teams, lead risk analyses and design controls, and ensure adherence to FDA and ISO standards while communicating findings and improvements clearly.

Qualifications

• Knowledge of medical procedures and corresponding medical equipment.
• Experience in CAPA execution and write-ups.
• Experience in Test Method Validation (TMV).
• Experience in Process Validation.
• Knowledge of medical equipment manufacturing processes.
• Knowledge of Quality Management and its tools & techniques.
• Knowledge of FDA, ISO 13485, ISO 14971 and compliance regulations.
• Knowledge of NC and audit processes.
• Knowledge in statistics, risk management and design controls.
• Excellent verbal and written communication; familiar with project management, problem solving and presentations.
• Minimum 5+ years of quality management experience in the medical device industry.

Skills

CAPA execution

TMV

Process Validation

Quality Management

FDA compliance

ISO 13485

ISO 14971

Risk management

Design controls

communication skills

project management

problem solving

presentation skills

statistics

data analysis

Tools

NCR process

AFMEA

DFMEA

PFMEA

validation protocols

CAPA tools

Statistical tools

Job description

Job Description

• Knowledge of Medical procedure and corresponding Medical Equipment
• Good experience in CAPA execution, CAPA write-up
• Good experience in Test Method Validation (TMV)
• Good experience in Process Validation.
• Knowledge of Medical Equipment manufacturing processes
• Knowledge on Quality Management and its tools & techniques
• Knowledge about FDA, ISO 13485, ISO 14971 and compliance regulations
• Knowledge on NC, Audit processes
• Knowledge in Statistic, Risk Management and Design control
• Must possess good communication skills (verbal and written), familiar with project management methodology, problem solving, and presentation skills
• A minimum with 5+ years of related experience Quality Management in Medical Device Industry.

Desirable Skills

• Working with other functional groups, including R&D and Operations in support of new product development, engineering projects, quality assurance activities, and lifecycle management.
• Utilizing Quality Engineering tools/processes in development and implementation of practices for the effective and efficient development.
• Non-Conformance Report (NCR) process for Sterilmed business unit.
• Develop and establish effective quality control and support associated risk management plans, AFMEA, DFMEA and PFMEA.
• Write, review and/or approve process and product validation protocols and reports, engineering change orders.
• Use statistical tools to analyze data, make acceptance decisions, and improve process capability, Design Controls, Design of Experiments
• Technical problem solving, failure analysis, and root cause determination.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Strong communication skills