Quality Engineer

Top Quality Recruitment (TQR); Kennesaw (GA); On-site; USD 75,000 - 105,000; Full time

Job summary

Top Quality Recruitment (TQR) is seeking a Quality Engineer to support product development through commercialization and sustainment, collaborating with cross-functional teams to ensure quality and regulatory compliance.

The role involves developing PFMEA, verification/validation plans, and reports, and reviewing designs for manufacturability and reliability. Candidates should have 2+ years in medical device quality and Lean/Six Sigma experience.

Qualifications

• BS in Engineering or Life Sciences; related field and manufacturing/medical device quality experience preferred.
• Minimum of 2+ years of medical device experience preferred.
• Experience with Lean and Six Sigma methodologies.
• Knowledge of regulatory requirements (FDA, Notified Bodies) and risk management standards.

Responsibilities

• Support product life cycle from development to commercialization and sustaining changes.
• Assist in PFMEA development and validation activities.
• Oversee verification and validation test plans, protocols, and reports.
• Ensure compliance with regulatory authorities including FDA and Notified Body.
• Review product designs for manufacturability, reliability, and testability.
• Participate in cross-functional teams to develop risk management files (DFMEA and risk reports).
• Manage multiple projects with detailed tasks and schedules.

Skills

Verbal communication

Written communication

Cross-functional collaboration

Risk management

Education

BS in Engineering or Life Sciences

Associate's degree in Engineering Technology

Tools

ISO 14971

DOE

SPC

IQ/OQ/PQ

Job description

The Quality Engineer is responsible for supporting all quality engineering activities to support the product life cycle, from development of new products (NPD) from concept through commercialization, through sustaining changes, as part of a cross-functional development team.

Key Activities

• Ensure successful transfer of new products to the production facility by assisting in the development of process validation requirements (PFMEA, IQ, OQ, PQ) using appropriate statistical tools and techniques.
• Assist in the creation of verification and validation test plans, protocols, and reports. Oversee testing and analysis for standards and product requirements compliance.
• Ensure that product development projects and changes to existing products are conducted in compliance with regulatory authorities including but not limited to the FDA and Notified Body.
• Review new and modified product designs for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.
• Participate in cross-functional teams to develop product risk management file (risk management plan, risk assessments, dFMEA, and risk management report).
• Ability to manage multiple projects simultaneously without much supervision. This includes creating detailed and accurate project tasks and schedules, interfacing with project team members and other support personnel and solving project-related conflicts and issues.

Preferred Skills

• Good verbal and written communication skills, including protocol / report development and technical presentations.
• Experience in Risk Management ISO 14971
• Experience of Process Validation (IQ, OQ, PQ), DOE, SPC and capability analysis.
• Experience of verification/validation test plan development and root cause failure analysis.

Educations & Experience

• BS in Engineering or Life Sciences or related field. Candidates with an Associate's degree in Engineering Technology or a related technical discipline, combined with relevant manufacturing or medical device quality experience, will also be considered.
• Minimum of 2+ years of medical device experience preferred.
• Experience in Lean and Six Sigma methodologies.

TQR is an equal-opportunity employer that encourages diversity. We will consider all applications.

Accommodation for applicants with disabilities is available upon request.