Quality Engineer

Job Title:

Quality Engineer I – 1st Shift

Location:

Covington, GA

Contract Term: 5+ Months | Weekly 40.00 Hours (Mon – Fri)

This position is responsible for working in the Bard Complaint Laboratory to perform product testing, as well as planning, organizing, and tracking work activities to ensure quality results and integrity of Bard complaint investigations. The Quality Engineer serves as a subject‑matter resource for Engineering, Operations, Sterilization, and outside suppliers.

• Create investigation files in the BARD Global complaint system (Trackwise).
• Perform complaint investigations for all BMD and OEM manufactured products.
• Manage completion of assigned complaint investigation files and work with manufacturing sites or suppliers to complete investigations in a timely manner.
• Provide support to Project Teams and Quality Department.
• Create, review, and approve Quality System Documents (SOP, CAPA, Audits, SPAs, and R002s).
• Set up, safely operate, and maintain laboratory equipment and testing instruments.
• Be responsible for all product testing in the Complaint Laboratory in accordance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
• Develop and maintain working knowledge of BMD policies, procedures, ISO and FDA requirements and ensure compliance with Department and Division procedures.
• Maintain accurate data, analyze and summarize conclusions from investigations and product analysis; may present findings to peers, engineering, and management staff.
• Work in a biohazard environment and comply with safety policies and procedures outlined by Bard policies.
• Perform tasks accurately with great attention to detail.
• Write technical documentation and provide timely notifications to FA specialists to meet FDA reporting requirements.
• Represent the Corporation, Division, and Quality Department in a professional manner.

• Perform engineering work of a broad nature with little or no direction from Quality Management.
• Basic knowledge of medical device regulation, industry or international standards.
• Broad knowledge of Medical Device complaint reporting requirements.
• Good laboratory skills and working knowledge of laboratory bench methods and associated equipment.
• Understanding of laboratory instrumentation.
• Good understanding of OSHA requirements, Quality Systems Regulations (QSR), GLP, ISO, AAMI, and FDA Guidelines.
• Broad knowledge of manufacturing processes.
• Excellent communication skills (verbal, written, and presentation); understand how to present information depending on the audience.
• Understand Fundamentals of Engineering Principles.
• Effectively manage time and priorities to meet deadlines.
• Handle multiple task assignments.
• Interpret Corporate, Division, and Department Procedures.
• Work with minimal supervision.
• Work in a team.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Prior laboratory experience desirable.
• B.S. in Engineering, Engineering Technology, Science, or a minimum.
• American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.) preferred.
• Experience with Access databases, Excel (PIVOT tables and charts), and complaint handling software (Trackwise or Pilgram).
• Minimum 1 to 3 years of experience in a regulated industry, including co‑op/internship experience.