Quality Engineer

Description

We are seeking a dedicated and detail-oriented Quality Engineer to join our team. In this role, you will be responsible for ensuring that our products and processes meet the highest standards of quality and reliability. You will work closely with cross-functional teams to develop and implement quality assurance processes that align with our organizational goals.

Key Responsibilities

Quality Assurance Integration: Collaborate with product development and manufacturing teams to ensure quality standards are integrated into all processes.

Inspection and Testing: Develop and initiate standards and methods for inspection, testing, and evaluation of products.

Document Review and Approval: Review and approve quality-related documents and plans to ensure conformance with quality system requirements.

Risk Assessments: Conduct risk assessments and failure mode effects analysis (FMEA) for new and existing products.

Quality Control Methods: Develop and implement quality control methods, procedures, and performance metrics for product design and manufacturing.

Problem Solving: Lead problem-solving and improvement activities to address quality issues and reduce product and process nonconformities.

Process Audits: Conduct audits of design and manufacturing processes to ensure compliance with quality system requirements and identify opportunities for improvement.

Data Analysis: Compile and analyze statistical data to identify and prioritize areas for quality improvement.

Reporting: Prepare and present reports on product and process quality to management and customers.

Training and Mentoring: Train and mentor staff on quality system requirements, quality tools, and best practices.

Skills

Quality engineering, Medical device, Root cause analysis, Quality management, documentation review

Top Skills Details

Quality engineering,Medical device,Root cause analysis

Additional Skills & Qualifications

Qualifications

Education: Bachelor’s degree in Engineering, Quality Assurance, or a related field.

Experience: 1-3 years of experience in quality assurance or a related role.

Skills:

Strong knowledge of quality assurance methodologies and inspection techniques.

Familiarity with product design and manufacturing processes.

Proficiency in quality tools and statistical analysis.

Excellent analytical and problem-solving skills.

Strong communication and interpersonal skills.

Ability to work collaboratively in a team environment.

Preferred Qualifications

Experience with ISO 13485:2016 and 21 CFR Part 820 standards.

Knowledge of risk management and FMEA.

Experience in conducting process audits and quality control.