Careers at Masis Staffing Solutions

Job Title: Quality Engineer II

Position Summary

The Quality Engineer II is responsible for supporting and improving quality systems and manufacturing processes within a regulated medical device manufacturing environment. This role focuses on process validation, supplier quality, risk management, and continuous improvement to ensure products meet regulatory, quality, and performance requirements. The position is an individual contributor and works cross-functionally with Engineering, Manufacturing, and Quality teams.

Essential Responsibilities

• Create, revise, and implement quality standards and procedures, including Standard Operating Procedures (SOPs), in alignment with established quality systems.
• Implement and evaluate improvements to existing manufacturing processes to enhance product quality, productivity, and overall equipment efficiency.
• Develop and maintain clear, accurate process documentation to ensure consistency and understanding across manufacturing teams.
• Provide technical support to manufacturing operations, including troubleshooting production issues, improving yield and throughput, reducing costs, and enhancing part quality.
• Independently start up, operate, and shut down process-related manufacturing equipment; support new process development and existing process optimization.
• Monitor tooling performance and recommend refurbishment or replacement based on cycle counts, process capability, and tooling history.
• Collaborate with internal stakeholders to resolve quality and manufacturing issues and provide project updates.
• Apply statistical tools and methodologies to support cost, quality, and delivery objectives.
• Support internal and external supplier quality activities, including evaluations, audits, and performance monitoring.
• Author and maintain validation documentation and protocols, including IQ, OQ, and PQ.
• Support design control activities, including verification and validation.
• Develop and review test methods to ensure compliance with specifications and standards.
• Conduct risk management activities, including FMEA, in accordance with ISO 14971 and related standards.
• Work with design documentation, including drawings, specifications, and records.
• Collaborate cross-functionally to support product transfers, regulatory compliance, and quality integration.
• Establish and evaluate supplier controls, including initial assessments and annual performance reviews.
• Review testing methodologies, equipment, and documentation to confirm suitability and compliance.
• Investigate product and system failures, perform root cause analysis, and implement corrective and preventive actions (CAPA).
• Verify implementation and effectiveness of quality improvements.
• Perform other duties as assigned.

Supervisory Responsibility

This position is an individual contributor with no direct supervisory responsibilities.

Work Environment

This role operates in both office and manufacturing environments and regularly uses standard office equipment. The position also involves interaction with manufacturing machinery and production equipment on the shop floor.

Physical Demands

The role requires standing, walking, stooping, and using hands and arms for handling and reaching. The employee must be able to lift and carry up to 20 pounds. Verbal communication and hearing are required regularly.

Position Type and Schedule

• Full-time position
• Standard schedule: Monday through Friday, daytime hours
• Occasional evening or weekend work may be required based on business needs

Travel

No routine travel required.

Required Education and Experience

• Bachelor’s degree in Engineering, Science, or a related discipline.
• 3–5 years of experience in quality control or quality assurance within a medical device manufacturing environment.
• Hands-on experience with injection molding and secondary processes such as bonding, printing, joining, laser welding, assembly, and packaging.
• Experience supporting and executing process validations (IQ, OQ, PQ).
• Working knowledge of FDA QSR, cGMP, ISO standards, and applicable international regulations.
• Familiarity with medical device sterilization processes (e.g., EO/EtO) is preferred.
• Strong understanding of manufacturing processes, tooling, equipment, materials, and quality systems.
• Knowledge of regulatory requirements including FDA, ISO, CE, and EU MDR/MDD.
• Lean Six Sigma Green Belt and/or ASQ certification preferred.

Skills and Competencies

• Strong verbal and written communication skills.
• Ability to communicate complex technical information across all organizational levels.
• Experience with quality systems auditing and regulatory compliance.
• Proficiency in MS Office and exposure to electronic quality management systems.
• High attention to detail and ability to produce accurate work in a fast-paced environment.
• Ability to handle confidential information professionally.
• Strong problem-solving and analytical skills.
• Results-driven with a continuous improvement mindset.

Masis Staffing is committed to providing a workplace free of discrimination, harassment, and retaliation. We are an equal opportunity employer. Applicants, employees, and former employees are protected from employment discrimination based on race, color, religion, sex (including pregnancy, sexual orientation or transgender status), national origin, aids (40 or older), veteran status, disability and genetic information (including family medical history).