Quality Engineer

Quality Engineer Job Description

The Quality Engineer will support the Quality organization by leading CAPA investigations, managing non-conformance processes, and driving key quality-related projects within a regulated manufacturing environment. This is an excellent position for those eager to grow in an FDA-regulated industry such as medical devices or pharmaceuticals. The role offers the opportunity to take ownership of critical quality activities, collaborate with cross-functional teams, and contribute to process improvements and QMS enhancements.

• Lead and manage CAPA (Corrective and Preventive Action) investigations from initiation through closure, ensuring thorough root cause analysis and effective corrective actions.
• Handle non-conformance processing and reporting, including documentation, tracking, and resolution of issues.
• Collaborate cross-functionally with Quality teams, Manufacturing, Manufacturing Sciences, and leadership stakeholders to resolve quality issues and support continuous improvement.
• Support and coordinate quality-related projects, including QMS system transitions, process improvement initiatives, and the development of new workflows and procedures.
• Facilitate meetings related to quality activities, including preparing agendas, taking detailed notes, and distributing action items and status updates.
• Maintain daily and weekly quality operations, including accurate and timely documentation in quality systems and databases.
• Apply quality engineering tools and methodologies such as FMEA, capability studies, measuring and test equipment studies, product validation, and reliability testing to assess and mitigate process-related risks.
• Support internal and external auditing activities by preparing documentation, participating in audits, and following up on findings.
• Progressively take on more independent ownership of CAPA, non-conformance, and assigned quality projects as onboarding and training milestones are achieved.
• Participate in internal training and shadowing of QA engineers during the initial ramp‑up period to gain familiarity with processes, systems, and regulatory expectations.

• 1+ years of related experience in an FDA-regulated environment such as medical device, pharmaceutical, or closely related industry, with real-world experience beyond internships.
• Hands‑on experience leading CAPA investigations, including responsibility for driving the process and investigations, not only participating as a team member.
• Experience with non-conformance management, including documentation, investigation, and resolution activities.
• Experience in quality engineering with practical use of root cause analysis tools and methodologies.
• Exposure to manufacturing environments with an understanding of production pace, priorities, and operations.
• Familiarity with FDA regulations and ISO standards relevant to medical device or pharmaceutical industries.
• Bachelor’s degree preferred in engineering or life sciences; an associate degree may be considered, but a completed degree is required for long-term conversion.
• Strong documentation skills with attention to detail and the ability to maintain accurate, compliant records.
• Ability to collaborate effectively with cross-functional teams and communicate clearly in both written and verbal forms.
• Capability to manage multiple tasks and projects in a structured and organized manner.

• Experience with project management, including planning, organizing, and tracking quality-related initiatives.
• Familiarity with Smart Soft‑QMS or similar electronic Quality Management Systems.
• Experience with assessment of process-related risks, including FMEA, capability studies, measuring and test equipment studies, product validation, and reliability testing.
• Auditing experience, including participation in internal or external audits and support of audit readiness activities.
• Knowledge of ISO 13485 and related quality system requirements, with certifications in ISO 13485 considered a plus.
• Experience in medical device or pharmaceutical manufacturing environments, including knowledge of industry-specific quality and…