Quality Engineer

JMD Technologies Inc.; Bethel (CT); On-site; USD 62,000 - 69,000; Full time

Job summary

JMD Technologies Inc. in Bethel, CT seeks a Quality Engineer III for a 6+ month contract to support new product introductions, risk management, and validations in a medical device manufacturing environment.

You will apply quality tools, lead root cause investigations, and develop test methods for equipment and process qualifications, with ISO 13485 and FDA 21 CFR 820 awareness required.

Qualifications

• Bachelor's degree in engineering or a related field.
• 2+ years in a quality engineering role in medical device manufacturing or startup.
• Familiar with ISO 13485 standards and FDA 21 CFR 820 regulations.
• Proven experience creating quality documentation.

Responsibilities

• Quality engineering and process improvement.
• Lead risk management and mitigation activities.
• Root cause analysis and corrective actions.
• Develop and qualify tests for equipment, processes, and products.
• Support validation activities.
• Maintain compliance documentation.

Skills

Quality engineering

Root cause analysis

Documentation

Risk management

Process improvement

Education

Bachelor's degree in engineering

Job description

Title: Quality Engineer III (3 Openings)

Location: Bethel, CT

Employment Type: Contract (6+ months, with strong potential to extend or convert)

Status: Accepting Candidates

About the Role

We are seeking a Quality Engineer III to support new product and process introductions, risk management, root cause investigations, and equipment, process, and product qualifications and validations within a medical device manufacturing environment.

Key Responsibilities

• Quality Engineering and Process Improvement
• Apply various tools and methods to identify and support new product or process introductions and business improvements.
• Lead and contribute to the development and application of innovative risk management and risk mitigation practices.
• Root Cause Analysis and Corrective Actions
• Lead and contribute to root cause investigations using various problem-solving techniques and tools.
• Assess the effectiveness of corrective actions.
• Testing, Qualification, and Validation
• Lead, conduct, and support the development of test methods for equipment, process, and product qualifications and validations.

Qualifications

• Bachelor's degree in Engineering or a similar field.
• 2+ years of experience in a Quality Engineering role within a medical device manufacturer or start-up company, or equivalent engineering experience.
• Familiarity with ISO 13485 standards and FDA 21 CFR 820 regulations.
• Proven experience creating job-related documentation for quality purposes.

Compensation

• Pay Rate: $45-$50/hour
• Location: Bethel, CT
• Duration: 6+ months, with strong potential to extend or convert