Quality Control Technician

Philips•Bedford, MA

1d•Onsite

About The Position

The Quality Control Technician is responsible for supporting highly complex quality control tasks to address manufacturing abnormalities, and coordinates quality control protocols while ensuring adherence to Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP). Your role: Supports the development of laboratory hygiene programs and regulatory documentation, acts as a mentor for junior technicians, and contributes to validation protocols and equipment maintenance. Coordinates the implementation of quality control procedures and protocols, ensuring adherence to good laboratory practices (GLP) and good manufacturing practices (GMP). Participates in developing and implementing the laboratory chemical hygiene program and coordinates the documentation of regulatory requirements for good manufacturing controls for medical devices as outlined in quality control plans. Acts as a specialized resource for quality control department with in-depth understanding of organization's tools and processes, providing guidance and support to junior technicians. Contributes to the development and execution of validation protocols and testing methods for new products and processes to ensure they meet quality standards. Coordinates the thorough maintenance of laboratory equipment to ensure accuracy and reliability of test results, adhering to regulatory standards and quality control measures. Participate in continuous quality improvement initiatives, such as Kaizen events and Lean manufacturing projects, to enhance operational excellence and product quality. Adheres to all safety protocols and guidelines, including the proper handling and disposal of hazardous materials, to maintain a safe working environment for oneself and others. Understands implications of work, makes recommendations for solutions, and utilizes experience and in-depth knowledge to complete a wide range of tasks in resourceful and effective ways.

Requirements

Minimum of 2+ years’ experience in FDA/ISO 13485 regulated Medical Device manufacturing quality environments, with a focus on production controls, supporting validations, administering calibration, quality records, incoming/in-process/final Inspection, using hand tools and optical inspection systems.
Proven experience working in a clean room environment, ensuring adherence to Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
Experience with laboratory hygiene programs and lab equipment maintenance, to ensure accuracy and reliability of test results, adhering to regulatory standards and quality control measures.
Minimum of a High School Diploma (REQUIRED) or Vocational Education.
Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

Responsibilities

Supports the development of laboratory hygiene programs and regulatory documentation.
Acts as a mentor for junior technicians.
Contributes to validation protocols and equipment maintenance.
Coordinates the implementation of quality control procedures and protocols, ensuring adherence to good laboratory practices (GLP) and good manufacturing practices (GMP).
Participates in developing and implementing the laboratory chemical hygiene program.
Coordinates the documentation of regulatory requirements for good manufacturing controls for medical devices as outlined in quality control plans.
Acts as a specialized resource for quality control department with in-depth understanding of organization's tools and processes, providing guidance and support to junior technicians.
Contributes to the development and execution of validation protocols and testing methods for new products and processes to ensure they meet quality standards.
Coordinates the thorough maintenance of laboratory equipment to ensure accuracy and reliability of test results, adhering to regulatory standards and quality control measures.
Participate in continuous quality improvement initiatives, such as Kaizen events and Lean manufacturing projects, to enhance operational excellence and product quality.
Adheres to all safety protocols and guidelines, including the proper handling and disposal of hazardous materials, to maintain a safe working environment for oneself and others.
Understands implications of work, makes recommendations for solutions, and utilizes experience and in-depth knowledge to complete a wide range of tasks in resourceful and effective ways.