POSITION SUMMARY:

We are seeking a self-driven, detail-oriented Quality Associate with a strong quality mindset to support supplier quality and distribution systems. This role works closely with internal teams and external suppliers to address quality gaps, analyze data, and implement effective solutions. The ideal candidate has experience in manufacturing environments, data analytics, and a solid understanding of quality systems. Blueprint reading skills are a plus.

QUALIFICATIONS & SKILLS:

• Bachelor’s degree in Engineering or related field.
• Minimum 3 years of relevant quality experience.
• Strong knowledge of risk management standards (e.g., ISO 14971).
• Experience with quality tools/methodologies such as QFD, Six Sigma, Lean.
• Familiarity with ISO 13485 or ISO 9001 quality systems.
• Preferred: ASQ certification and experience in FDA-regulated environments.
• Ability to read and interpret technical drawings, schematics, and process documentation.
• Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook) and general PC skills.
• Excellent analytical, organizational, and communication skills.
• Ability to work independently and in cross-functional teams, managing multiple priorities.
• Proactive, adaptable, and detail-oriented mindset.

• Collaborate with supplier quality teams to identify and close gaps in supplier quality and distribution processes.
• Analyze quality data to identify trends, issues, and opportunities for improvement.
• Partner with Engineering and Manufacturing to define acceptance criteria for production processes.
• Investigate product issues, perform root cause analysis, and recommend corrective and preventive actions (CAPA).
• Assist in developing, updating, and implementing quality management system (QMS) procedures.
• Review and disposition nonconforming materials and process deviations.
• Support manufacturing process creation, validation, and quality alerts.
• Conduct internal audits of production processes and present findings.
• Participate in external regulatory and customer audits.
• Provide quality-related input for tenders and sales efforts.