Associate Quality Engineer

HireLifeScience; Johns Creek (GA); On-site; USD 60,000 - 85,000; Full time

Job summary

HireLifeScience seeks an Associate Quality Engineer to maintain quality and control of medical device manufacturing and post-market performance. You will collaborate with internal and external stakeholders, lead root cause investigations, and develop risk-based decisions to resolve issues.

You will ensure compliance with FDA, ISO 13485, and other global regulatory requirements, and represent Quality in cross-functional projects. 0-2 years’ regulated industry experience is expected.

Qualifications

• 0-2 years of experience in Medical Device /Pharmaceutical regulated industry.
• Bachelor's Degree with Engineering or Physical Science Coursework.
• ASQ Certification (e.g. CQA, CQE, CQM) preferred.

Responsibilities

• Develops and executes plans for quality and control to ensure manufacturing continuity and product conformance.
• Leads investigations into production and customer-facing quality issues to identify root cause and implement corrective actions.
• Monitors and analyzes product performance using a statistical and risk-based approach.

Skills

Cross functional communication

Critical thinking

Prioritization

Education

Bachelor's degree in Engineering or Physical Science

ASQ Certification (CQA/CQE/CQM)

Job description

Description: The Associate Quality Engineer is responsible for maintaining quality and control of manufacturing processes and post-market performance of medical devices. Responsibilities include collaborating with internal and external stakeholders to achieve company objectives, leading technical root cause investigations, developing and executing risk-based decisions, resolving and documenting customer complaint and manufacturing investigations, and representing Quality in cross-functional projects.

Job Duties

• Develops and executes plans for quality and control to ensure manufacturing continuity and product conformance.
• Leads investigations into production and customer-facing quality issues to identify root cause, implement corrective and preventative actions, and monitor effectiveness
• Monitors and analyses product performance of medical devices using a statistical and risk-based approach. Considers any quality, compliance, customer, and business risks.
• Performs hands-on troubleshooting of customer returned devices and manufacturing nonconformities and completes associated technical documentation
• Develops tools to communicate complex technical problems and solutions to a variety of audiences within the organization
• Proficient in project management, data analysis, root cause analysis, communication, and risk determination
• Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies as pertaining to medical devices.

Top 3 must-have skill sets

Cross functional communication skills (will be working with all teams), Critical thinking (allows for quick on the spot thinking and ways to navigate unfamiliar issues), prioritization (this position will pull you in all directions so knowing what is important is key)

Years of experience required

0-2 years of experience in Medical Device /Pharmaceutical regulated industry.

Specific education requirements

Minimum - Bachelor's Degree with Engineering or Physical Science Coursework,

Preferred

Preferred - Bachelor's or Master's Degree in Engineering with 0-3 years' experience in Medical Device /Pharmaceutical regulated industry. ASQ Certification (e .g. CQA, CQE, CQM )

Custom Fields

• System Access Required: Yes
• Invoice Type: USA-ARL-Staffing-USD
• Supervisory Org: Quality Operations(Chris Rodriguez)-60004997
• Work Desk Phone Number Required: No
• Badge ID Required: Yes
• Workspace: None
• Worker Time Type: Full Time
• Remote Worker: No