Quality Engineer

Position: Quality Engineer 2
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.

Responsibilities

* 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.

Essential Skills

* 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.

* 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.

Additional

Skills & Qualifications

* 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 (Failure Modes and Effects Analysis), 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 regulatory expectations.

* Demonstrated ability to support QMS system transitions and contribute to the development of new workflows and procedures.

* Strong organizational and time-management skills, with the ability to prioritize tasks in a fast-paced environment.

* Motivation to grow within a regulated industry and take on increasing responsibility over time.

Work Environment

This is a full-time, onsite role with standard hours of 8:00 a.m. to 5:00 p.m., Monday through Friday. The position is primarily desk-based with a heavy focus on documentation, investigations, and coordination activities. You will work closely with Quality, Manufacturing, and Manufacturing Sciences teams in a regulated manufacturing setting that follows FDA and ISO…