Work Schedule

First Shift (Days)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, high vis vest, ear plugs etc.)

Job Description
Technical Responsibilities
•    Responsible for implementing and maintaining the efficiency of the quality system.
•    Perform in-process quality inspections during manufacturing to resolve products are meeting approved requirements.
•    Identify and address in-process quality concerns in a timely manner to mitigate failures.
•    Record in-process quality inspections to determine acceptance of materials from manufacturing.
•    Track the number of defects identified during the inspection.
•    Collaborate with Quality Assurance and Operations to find opportunities for continual improvement based upon data collected.
•    Partner with manufacturing personnel for line opening and line closing activities.
•    Document nonconformances in the quality management system and participate as needed in the investigations.
•    An alternate work schedule may be required to accommodate manufacturing changes, including occasional weekend work.
•    Off-shift work is required
•    Carry out and facilitate additional duties as assigned.

Other Responsibilities
•    Trains inspection employees on procedures and operations as needed.
•    Work with the MQC Team to identify issues, resource needs and improvement opportunities. Collaborate to offer suggestions for resolution/improvements.
•    Provide corrective actions when needed.
•    Continuously monitor work area for unsafe conditions and take immediate action to address unsafe conditions.
Key Responsibilities
•    Inspection: Conduct inspections of finished products to ensure they meet predetermined quality standards and specifications.
•    Identify and record any defects or non-conformances.
•    Schedule and perform inspections alongside our customer. 
•    Documentation and Reporting: Maintain accurate and detailed records of inspections.
•    Record and non-conformances
•    Compliance and Standards: Ensure all quality control activities align with ISO 13485 and other relevant regulatory standards.

Collaboration and Communication
•    Work closely with production teams to address and resolve quality issues.
•    Work closely with warehouse teams to address and resolve quality issues.
•    Communicate effectively with other departments to ensure quality standards are understood and met.
Continuous Improvement
•    Participate in continuous improvement initiatives to improve product quality and production efficiency.
•    Find opportunities for process improvements and contribute to the development and implementation of quality control processes.
Safety and Environmental Compliance
•    Follow all safety and environmental regulations and standards.
•    Promote a safe working environment by following safety protocols and reporting any hazards.

Qualifications
•    High school diploma or equivalent.
•    Minimum of 2 years of experience in quality control, preferably in a manufacturing environment that adheres to ISO 13485 standards or other similar quality standard.
•    Solid understanding of quality control principles, regulatory requirements, and ISO 13485 standards.
•    Excellent attention to detail and problem-solving skills.
•    Strong time management skills and the ability to multitask effectively
•    Effective and collaborative communication abilities.
•    Ability to work independently and as part of a team.
•    Strong written and verbal communication skills.
Physical Requirements
•    Ability to walk and stand for prolonged periods at various times.
•    Ability to handle objects weighing up to 40 pounds.
•    Ability to perform repetitive tasks.
Work Environment
•    The job is performed on the production floor, and warehouse area which may involve exposure to noise, dust, and varying temperatures.
•    Personal protective equipment (PPE) will be required.

Why Join Us?
•    At Thermo Fisher, we provide competitive compensation, comprehensive benefits, and opportunities for professional growth.