Quality Engineer I

Job Purpose:

Support and maintain compliance of the medical device Quality Management System (QMS) by performing quality engineering activities under guidance. Ensure all medical devices are manufactured in accordance with FDA regulations, ISO 13485:2016, and internal quality and safety standards.

Essential Duties and Responsibilities:

• Ensure compliance with FDA 21 CFR Part 820, ISO 13485:2016, and other applicable regulatory and quality standards for medical device manufacturing.
• Support and maintain quality system processes including CAPA, Nonconformance (NC), Complaint Handling, Document Control, Risk Management, and Supplier Quality.
• Act as a key user of the Electronic Quality Management System (iQMS), ensuring accurate data entry, reporting, and system maintenance for quality-related activities.
• Understand and assist with incoming, in-process, and final product inspections, including sampling plans, inspection methods, and measurement system analysis to support production.
• Participate in internal audits and assist in external (regulatory, notified body, customer, and supplier) audits.
• Assist in preparation and execution of Management Review by compiling and analyzing quality metrics and system performance data.
• Collaborate with Manufacturing, R&D, and Engineering to address quality issues and implement effective corrective and preventive actions (CAPAs).
• Support product and process validation activities including protocol development, execution, and reporting for IQ/OQ/PQ.
• Contribute to sterilization validation activities and routine revalidations in accordance with ISO 11135/11137 or other applicable standards.
• Participate in continuous improvement initiatives (Lean, Six Sigma, Kaizen, 5S) aimed at enhancing product quality and process efficiency.
• Assist in authoring and reviewing Standard Operating Procedures (SOPs), Work Instructions, Quality Plans, and Validation Protocols/Reports.
• Monitor and report on Key Performance Indicators (KPIs) to support the effectiveness and improvement of the QMS.
• Assist with calibration and maintenance of critical measurement equipment used in product inspection and validation.
• Conduct supplier audits and performance evaluations and act as Supplier Quality Representative when needed.
• Participate in risk management activities and support the development and maintenance of Design and Process FMEAs.
• Maintain compliance with cleanroom (ISO Class 8) protocols and environmental monitoring requirements.
• Work as a functional team member with other production engineers on Value Stream Team activities, improving first pass yields, reducing scrap, complaint investigations.

Competencies:

• Regulatory Knowledge – Basic understanding of FDA QSR, ISO 13485, and quality system requirements for medical devices.
• Attention to Detail – Accurate data entry, document review, and inspection results with minimal oversight.
• Problem Solving – Applies structured methods (e.g., 5 Whys) to support root cause analysis and basic CAPA tasks.
• Technical Writing – Capable of writing SOPs, work instructions, protocols, and quality records with guidance.
• Collaboration – Works effectively in cross-functional teams with Manufacturing, Engineering, and Quality.
• Inspection & Measurement – Proficient with basic inspection tools, gages, and methods; comfortable working in cleanroom environments.
• Time Management – Manages assigned tasks and deadlines reliably, balances routine duties and project work.

Qualifications:

Required:

• Bachelor’s Degree in Engineering (Mechanical, Biomedical, Industrial, or related technical field).
• Minimum of 2 years’ experience in a regulated industry (preferably medical devices or pharmaceuticals).
• Understanding of quality system regulations (FDA QSR, ISO 13485).
• Ability to read and interpret engineering drawings and specifications.
• Strong attention to detail and organizational skills.
• Effective communication and interpersonal skills.
• Proficiency in Microsoft Office and familiarity with iQMS platforms.
• Willingness to work in controlled manufacturing environments (e.g., cleanrooms).
• Ability to interpret and comply with quality and regulatory requirements.

Preferred:

• Prior experience in medical device manufacturing or regulated industry.
• Knowledge of risk management principles (ISO 14971), sterilization validation (ISO 11135/11137), and cleanroom practices.
• Experience with statistical tools (SPC, Minitab), data analysis, and measurement systems.
• Lean Six Sigma Green Belt or higher.
• Familiarity with GD&T, precision measurement tools (e.g., CMM, optical comparators, vision systems).
• Experience working with suppliers and supporting supplier quality initiatives.
• ISO 13485 lead auditor certification

Working Conditions:

• Approximately 50% of time spent at a desk or computer; 50% on the production floor or in cleanroom environments.
• Must wear appropriate cleanroom attire when required.
• May involve occasional travel for supplier audits or training.