Quality Engineer

Job Title:

Quality Engineer

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 position is well suited for a junior‑level engineer with 1–2 years of experience who is 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 a 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.
• Background 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…