Quality Engineer 2, Quality Operations - Clinical Laboratory # 4790

Responsibilities:

• Leads engineering analyses of inspection and production data to assess product performance, identify quality issues, and recommend actions within defined procedures.

• Conducts quality investigations, including root cause analysis, documentation, and assisting in the development and implementation of corrective and preventive actions.

• Develops or updates qualification and inspection criteria, quality procedures, and documentation in alignment with established quality assurance standards and engineering requirements.

• Collaborates with technicians and cross-functional partners to ensure inspection activities and product evaluations align with specifications, drawings, and quality expectations.

• Evaluates nonconforming materials by reviewing defect information, assessing potential impact, and coordinating disposition activities with quality or engineering personnel.

• Responsible for supplier quality activities by reviewing incoming inspection results, documenting issues, and supporting supplier corrective action processes.

• Prepares technical reports, data summaries, and quality records to support audits, internal reviews, and ongoing compliance with company methods and regulatory requirements.

• Makes decisions for quality planning and continuous improvement efforts by identifying trends, providing input on process enhancements, and applying quality tools and analytical methods.

• May participate in internal, external or supplier audit activities.

• These responsibilities summarize the role’s primary responsibilities and are not an exhaustive list. They may change at the company’s discretion.

Required Qualifications:

• Bachelor’s degree in Engineering, Quality, Manufacturing, or related technical discipline.

• 2–5 years of relevant quality, manufacturing, or engineering experience; Master’s degree with 0–2 years of experience acceptable.

• Demonstrated level of knowledge regarding applicable regulatory standards commensurate with the position's complexity and scope, contributing to organizational regulatory compliance. Minimal applicable standards for this position include:  

• GMP quality management systems (e.g. ISO 13485)

• Risk assessment frameworks (e.g. ISO 14971)

• Clinical laboratory regulations (e.g. CAP, CLIA, NYSDOH, ISO 15189)

• Operations within the regulated medical device environment (e.g. IVDD, IVDR, FDA 21 CFR 800 series, FDA 21 CFR Part 11)

• Solid knowledge of quality engineering principles, standards, and regulatory requirements.

• Proficiency in root cause analysis, CAPA, and data-driven problem solving.

• Ability to interpret engineering drawings, specifications, and GD&T.

• Familiarity with quality management systems (QMS) and regulatory compliance frameworks (ISO, GMP, FDA, etc.).

• Strong communication and technical writing skills.

Preferred Qualifications:

• Effective project and time management abilities.

• Skilled in the use of statistical analysis and quality tools (SPC, Minitab, or similar).

• Ability to work independently and collaboratively in a team environment.

Physical Demands and Work Environment

• Work is performed in office, laboratory, and manufacturing environments.

• Regular interaction with production floor operations for quality reviews and troubleshooting.

• Use of precision measurement and inspection equipment as needed.

• Potential exposure to manufacturing noise, equipment, and regulated materials.

• PPE required when performing inspections or working in controlled environments.

• Standard business schedule with occasional overtime or travel to supplier sites or customer locations.