Supervisor - Systems Engineer

Role Summary

This position is responsible for supervising core duties and personnel within the Systems Engineering team. This role will oversee equipment verifications in the MI Cancer Seek (FDA) and Caris Assure (CAP/CLIA) laboratories and associated operations including IHC, Digital Pathology, Laboratory Operations, and Research and Development. This supervisor also supports software validation, system administration, project management, and the Cross Correlation Program.

Responsibilities

• Ensure equipment verification record compliance with all applicable regulatory requirements (CLIA, NYS, CAP, ISO, FDA, IVDR, etc.).
• Quality review CMMS work orders and associated documentation generated from all Phoenix sites.
• Oversee use of software tools including the CMMS and electronic logbook platform to provide training, end user support, and quality review.
• Manage the CAP-required Cross Correlation program and associated records.
• Author, review, revise, and implement standard operating procedures (SOPs).
• Participate in internal and external audits with tasks such as audit preparation, answering questions, and providing documentation to auditors.
• Support various projects and initiatives within the System Engineering teams.
• Manage company records in accordance with regulatory requirements and company policies.
• Engage in cross-functional collaborations between Systems Engineering, Laboratory, IT, Software QA, and Quality teams to support program alignment between organizational and regulatory requirements.
• Supervise applicable personnel and tasks as delegated by Systems Engineering Management.

Qualifications

• Required: Bachelor’s degree in engineering, biological science, computer science, or similar field
• Required: Three years of experience working in a regulated environment (CAP, CLIA, NYS, FDA, ISO, etc.).
• Required: A strong knowledge of requirements per CAP/CLIA, ISO 13485, 21 CFR 820, and 21 CFR Part 11.
• Required: Previous experience supervising and/or training other on processes.
• Required: Knowledge of laboratory practices, instrumentation, safety procedures, etc.
• Required: A drive for results (Service, Quality, and Continuous Improvement) in a fast-paced laboratory environment.
• Required: Proficient in Microsoft Office Suite, specifically Word, Excel, Outlook, and general working knowledge of Internet for business use.
• Preferred: Three years of experience working in a quality or engineer role within a regulated laboratory environment with a focus on laboratory instrumentation and equipment.
• Preferred: Experience leading or directly supporting complex projects like process improvement and software implementations.
• Preferred: Master’s degree in biological science, chemistry, engineering, or related field.
• Preferred: Lean Six Sigma Certified

Physical Demands

• Employee must be able to use standard office equipment.
• Employee must have ability to sit and stand for extended periods of time.
• Work is split between a desk/cubicle environment and a laboratory environment. Employee may have exposure to high noise levels, fumes, and biohazardous materials in the laboratory environment.

Training

• All job specific, safety, and compliance training are assigned based on the job functions associated with this employee.

Other

• This position requires some evenings, weekends and/or holidays.