Quality Engineer II

Top 3 technical skills that are required for the role:

1. Experience working in a clean room or regulated manufacturing environment.

2. 3+ years of experience in the medical device industry, with a strong background in Non -Conforming Materials Reports (NCMR), CAPA, or product quality management.

3. Excellent problem-solving and analytical skills, with the ability to identify root causes and implement effective corrective actions

Education Required & Years’ Experience Required:

Requires a University Degree and minimum of 3 years of experience.

Quality Specialist – Medical Device Industry

Seeking a professional with 3+ years’ experience in medical device quality management, including NCMR, CAPA, and process validation. Requires strong knowledge of FDA (21 CFR Part 820), ISO 13485, EU MDR, and related regulations. Proven ability to lead NCMR and CAPA processes.

Day-to-Day Responsibilities:

• Partner with Manufacturing Engineering and Supervisors to assess and determine routes for non-conformances (NCs) and potential NCs
• Conduct quality line walks to ensure compliance and audit readiness
• Own and collaborate on Quality Management System (QMS) and Process change orders
• Represent Quality in process improvement projects
• Collaborate with cross-functional teams to resolve quality issues
• Ensure corrective actions and documentation meet regulatory and internal standards

TECHNICAL SKILLS
Must Have

• 3+ years of experience in the medical device industry, with a strong background in Non -Conforming Materials Reports (NCMR), CAPA, or product quality management.
• Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, EU MDR, and other relevant medical device regulations.
• Proven experience leading NCMR and CAPA processes, ideally within a medical device or regulated industry.
• Strong project management skills, with the ability to manage multiple priorities and deadlines.
• Excellent problem-solving and analytical skills, with the ability to identify root causes and implement effective corrective actions.
• Outstanding communication and interpersonal skills, capable of effectively working with cross-functional teams and external stakeholders.
• Proficiency in Microsoft Office Suite and quality management systems (QMS).
• Strong technical writing capability. Experience in Process Validation.
• Experience working in a clean room or regulated manufacturing environment.

Nice To Have

• DMAIC, process mapping, 5 Whys, Is/Is Not analysis - scientific problem-solving methodologies
• Experience with Agile Map change control systems
• Familiarity with SAP ERP manufacturing systems and electronic manufacturing execution systems (MES)