Quality Operation Analyst

eTeam; Greenville (SC); On-site; USD 29,000 - 40,000; Full time

Job summary

eTeam is seeking a Quality Operations Analyst (Medical Devices) to join our Greenville, SC team. You will lead investigations into nonconformances, perform root cause analyses, and prepare audit-ready documentation in a regulated environment.

Responsibilities include driving CAPA, containment actions, and preventive measures in collaboration with Quality and Operations, while maintaining accurate QMS records and monitoring risk and metrics.

Qualifications

• Bachelor's degree in engineering, life sciences, quality or related field.
• 3+ years in manufacturing or quality, preferably in a medical device or regulated environment.

Responsibilities

• Lead investigations of nonconformances (NCRs) and document findings for audit-ready records.
• Perform root cause analysis using structured tools (5 Whys, fishbone, Pareto).
• Recommend containment, corrective and preventive actions with QA and Operations.
• Prepare audit-ready reports and maintain QMS records for traceability.
• Monitor trends, support risk assessments, and drive Lean/Six Sigma improvements.
• Support Quality Inspection as needed.

Skills

Communication skills

MS Office Proficiency

Data analysis

Prioritization

Team oriented

Independent worker

Education

Bachelor's degree in engineering, life sciences, quality

Tools

Microsoft Excel

Minitab

Job description

Job Title: Quality Operations Analyst (Medical Devices)
Location: Greenville, SC
Duration: 12 Months
Pay Rate: $25/hr on W2

Job Description

Join a fast-paced medical device production environment where you will lead the investigation and documentation of nonconformance reports (NCRs). You will collaborate closely with the quality and manufacturing teams to ensure issues are accurately captured, analyzed for root cause, and communicated through audit-ready documentation aligned with applicable regulations and standards.

Responsibilities

• Lead timely investigations of product and process nonconformance events; collect evidence, interview stakeholders, and document findings to create clear, complete NCRs.
• Perform root cause analysis using structured tools (5 Whys, fishbone, Pareto) and recommend containment, correction, and corrective/preventive actions in partnership with Quality and Operations.
• Prepare concise, audit-ready reports; maintain accurate records within the Quality Management System (QMS) to ensure traceability and data integrity.
• Monitor trends and metrics, support risk assessments, and contribute to continuous improvement initiatives using Lean and Six Sigma principles.
• Support Quality Inspection, as needed
• The list of duties and responsibilities is not exhaustive and may include and/or be substituted as necessary with other tasks as defined by management.

Minimum Requirements

• Education: Bachelor's degree in engineering, life sciences, quality, or a related field; or equivalent practical experience.
• Experience: 3+ years in manufacturing or quality, preferably in a medical device or other regulated environment.

Skills

• Energetic, driven, self-guided, team-oriented and operationally focused.
• Ability to prioritize tasks and juggle competing and changing deadlines effectively while remaining calm under pressure.
• Effective interpersonal skills with the ability to work in a team environment and to follow directions.
• Excellent verbal and written communication skills.
• Advanced proficiency in MicrosoftTM Suite (i.e. Word, Excel, and Outlook, etc.).
• Ability to make decisions and work independently.
• Ability to work on multiple tasks at one time.
• Ability to analyze data and present in a logical manner.

Preferred Qualifications

• Working knowledge of ISO standards relevant to medical devices (e.g., ISO 13485), 21 CFR 820, Good Manufacturing Practice (GMP), and Total Quality Management (TQM).
• Hands-on experience with Corrective and Preventive Action (CAPA), nonconformance workflows, and electronic QMS platforms.
• Six Sigma . Belt or equivalent; proficiency with data analysis tools such as Excel or Minitab.

Work Environment

Temperature controlled office and manufacturing environment with large printing and related equipment.

Physical Requirements

Sitting, standing, walking, stooping, bending, climbing stairs and ability to lift 50 pounds. Bachelor's Degree Required