JOB TITLE: Quality Engineer Lead
SUMMARY:
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.
DUTIES AND 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.
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.
SUPERVISORY RESPONSIBILITIES: Not required.
EDUCATION AND/OR EXPERIENCE: ·
Bachelor’s degree in Science, Engineering, or a related field, or equivalent combination of education and experience. 3 years of experience in Change Controls, Work Instruction (WI)/Quality System Procedure (QSP) authoring, deviations, and NCRs is required.· 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. PHYSICAL DEMAND:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Sit, Stand, Move, Bending, Talk/Hear, Vision, Lift up to 15 lbs.
WORK ENVIRONMENT:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
TRAVEL REQUIREMENT:
Not required. The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. LifeSync provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. The Age Discrimination in Employment Act (ADEA) forbids age discrimination against people who are age 40 or older. It does not protect workers under the age of 40, although some states have laws that protect younger workers from age discrimination. It is not illegal for an employer or other covered entity to favor an older worker over a younger one, even if both workers are age 40 or older. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
