Engineer Tech - QA - SC

Arthrex - Pendleton, SC

Full-time

Pendleton, SC

Miscellaneous Manufacturing

About the position

The Engineer Tech - QA position at Arthrex Inc. is a critical role within the Engineering department, focusing on the lifecycle development of medical devices. This position is responsible for supporting engineers in various capacities, including new product development and the maintenance of existing products. The main objective is to ensure that all engineering processes meet the highest quality standards, thereby contributing to the overall success of the company's medical device offerings. In this role, the engineer will engage in a variety of essential duties and responsibilities. One of the primary tasks includes conducting Root Cause Analysis Investigations and assisting or leading Corrective/Preventive Action Plans (CAPA) investigations. The engineer will also facilitate the completion of manufacturing and supplier-related Nonconformances (NCRs), which involves creating material disposition plans, evaluations, and action plans as assigned. The position requires performing routine Nonconformance and process trending, as well as leading periodic Quality review meetings with the management team. Investigating post-market related manufacturing quality issues is another key responsibility, which includes complaint investigations, complaint trending, and initiating corrective and preventative actions as necessary. The engineer will also initiate and coordinate risk assessment activities in accordance with Quality System requirements. Continuous Improvement projects are a significant aspect of this role, where the engineer will support, initiate, or lead these initiatives. Additionally, the engineer will review drawings for inspectability, manufacturability, and quality of design issues, and will be responsible for creating and reviewing inspection plans for manufacturing and receiving inspection. Collaboration with Metrology is essential, as the engineer will assist in the design and development of inspection methods and gages, as well as train QC Inspectors on inspection techniques and the use of new equipment. The engineer will also support the AMI Engineering Change Management process and lead the internal manufacturing First Article Inspection process, reviewing reports and samples as needed. Other responsibilities include performing Engineering Studies and Design of Experiments (DOE), supporting or leading equipment or process validation (IQ, OQ, PQ), and conducting Measurement System Analysis (Gage R&R) studies. The engineer will work closely with suppliers to enhance quality and assist in supplier RCA and improvement initiatives. Participation in internal and external quality audits as directed by the Quality Assurance Manager is also required, along with supporting Risk Management by leading or participating in cross-functional team pFMEAs and Risk Assessments as needed. Additional duties may be assigned as necessary.

Responsibilities

• Complete Root Cause Analysis Investigations and assist or lead Corrective/Preventive Action Plans (CAPA's) investigations.
• Facilitate completion of manufacturing and supplier related Nonconformances (NCR's) as assigned: material disposition plans, evaluations, and action plans.
• Perform routine Nonconformance and process trending and lead periodic Quality review meetings with the management team as needed.
• Investigate post market related manufacturing quality issues including complaint investigations, complaint trending, and initiating corrective and preventative actions as required.
• Initiate and coordinate risk assessment activities in accordance with Quality System requirements.
• Support, initiate or lead Continuous Improvement projects.
• Responsible for reviewing drawings for inspect-ability, manufacturability, and quality of design issues and subsequent creation and review of inspection plans for manufacturing, receiving inspection.
• Support Metrology with design and development of inspection methods and gages and assist in the training of QC Inspectors on inspection techniques and the use of new equipment.
• Support the AMI Engineering Change Management process by performing tasks as assigned.
• Support or Lead the internal manufacturing First Article Inspection process, review First Article Inspection Reports and samples (internal and/or supplier).
• Perform Engineering Studies and Design of Experiments (DOE) as needed.
• Support or Lead equipment or process validation (IQ, OQ, PQ).
• Support or Lead Metrology with Measurement System Analysis (Gage R&R) studies.
• Work with suppliers to improve quality, and assist, where necessary, supplier RCA and improvement initiatives.
• Participate in Internal and External quality audits as directed by the Quality Assurance Manager.
• Support Risk Management by leading or participating in cross-functional team pFMEA's and Risk Assessments as required.

Requirements

• Experience in quality assurance or engineering roles, preferably in the medical device industry.
• Strong understanding of quality systems and regulatory requirements related to medical devices.
• Proficient in Root Cause Analysis and Corrective/Preventive Action methodologies.
• Experience with Nonconformance and process trending analysis.
• Ability to conduct investigations related to manufacturing quality issues and complaints.
• Familiarity with risk assessment activities and methodologies.
• Experience in Continuous Improvement projects and methodologies.
• Strong analytical skills and attention to detail.
• Excellent communication and interpersonal skills to work effectively with cross-functional teams.

Nice-to-haves

• Experience with Design of Experiments (DOE) and Engineering Studies.
• Knowledge of Metrology and Measurement System Analysis (Gage R&R).
• Familiarity with supplier quality improvement initiatives.
• Experience in conducting internal and external quality audits.