Quality Engineer Lead
About The Position
The Quality Engineer Lead is an junior-level role responsible for supporting day-to-day quality assurance activities at LifeSync, with a primary focus on Non-Conformance Reports (NCRs), complaint investigations, deviations, and Supplier Corrective Action Reports (SCARs). This role provides hands-on support across general quality functions, working under the guidance of senior quality engineering staff to help ensure products meet applicable regulatory and quality requirements. This position supports the day-to-day execution of quality processes, including documentation, investigation support, and cross-functional coordination with manufacturing, engineering, and supply chain. The Quality Engineer Lead gains exposure to core quality systems and regulatory requirements while building foundational skills in root cause analysis, corrective action, and quality documentation. This role also provides an opportunity to develop a working knowledge of LEAN principles and LifeSync’s Quality Management System (QMS), building the foundation needed to take on increasing responsibility within the Quality organization over time. Through consistent, detail-oriented support and cross-functional collaboration, the Quality Engineer Lead contributes to the team’s ability to maintain compliance, resolve quality issues efficiently, and continuously improve LifeSync’s Quality Management System.
Requirements
- Strong attention to detail and organizational skills.
- Good written and verbal communication skills.
- Ability to follow established procedures and work effectively under supervision.
- Basic analytical and problem-solving skills.
- Proficiency with Microsoft Office; experience with quality systems software is a plus.
- 100% on-site is required. Occasional remote days acceptable with planning and coordination.
Nice To Haves
- Experience with test method validations and equipment/tooling calibrations, required to support manufacturing and test transfers and engineering support projects is preferred.
- Medical device or pharmaceutical industry experience is preferred, ensuring familiarity with applicable FDA requirements.
- Experience leading QC inspectors or managing incoming inspection is preferred; this role is expected to take on oversight of inspection activities over time.
Responsibilities
- Process Non-Conformance Reports (NCRs), including documentation and investigation, tracking dispositions through closure.
- Execute complaint investigations, gathering relevant data, coordinating with cross-functional teams, and documenting findings.
- Execute the deviation process, including documentation, tracking, and follow-up on corrective actions.
- Support Corrective and Preventive Action (CAPA) activities, including documentation, tracking, and follow-up through closure.
- Execute the Supplier Corrective Action Report (SCAR) process, coordinating with suppliers on root cause analysis and verifying corrective action effectiveness.
- Assist with root cause analysis for nonconformances, complaints, and deviations under the guidance of senior quality staff.
- Execute Material Review Board (MRB) activities, including documentation and disposition tracking.
- Help maintain and update quality metrics, reports, and dashboards.
- Support internal audits and inspection readiness activities as assigned.
- Assist with calibration and preventive maintenance tracking for quality-related tools and equipment.
- Support test method validation activities to enable manufacturing and test transfers and engineering support projects.
- Provide guidance and coordination for QC inspectors and incoming inspection activities, with growing responsibility for oversight over time.
- Support the creation, review, and maintenance of quality system procedures, work instructions, and related documentation.
- Collaborate with manufacturing, engineering, and supply chain teams to help resolve quality issues and support continuous improvement initiatives.
- Perform other general quality support tasks and activities as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
