Packaging Testing Technician II - Medical Device #4213

The Packaging Testing Technician II supports the development, testing, and validation of medical device packaging systems to ensure product safety, sterility, and regulatory compliance. This role performs hands-on laboratory testing, supports packaging validations, maintains lab equipment, and assists with documentation in accordance with FDA, ISO, and internal quality standards.

What You'll Do

• Hands-On Testing:

Execute packaging testing procedures according to established protocols and methodologies.

Operate testing equipment to assess package integrity, stability testing, performance testing, test methods and other relevant parameters.

Utilize precision measurement tools, gauges, and test equipment to verify compliance with specifications.

• Equipment Set-Up and Calibration:

Set up testing equipment for various packaging tests as directed by the Packaging Engineer.

Verify that calibrated equipment meets required specifications.

Support compliance with internal quality standards and external regulations.

• Data Gathering and Documentation:

Gather data during testing procedures, ensuring accuracy and completeness.

Document testing processes, results, and any observations in accordance with established procedures. The responsibilities described above must be supervised by the Quality engineer in charge.

• Collaboration with Testing Team:

Work closely with the testing team to support ongoing projects and ensure efficient lab operations.

Ensure quality control checkpoints are integrated into testing protocols for medical devices.

• Quality Control Support

Follow procedures for accurate documentation and reporting of test results.

Support daily quality control operations by performing inspections of raw materials, components, and finished medical devices.

Verify that the work orders performed meet established specifications and regulatory requirements before release.

• Training and Development:

Participate in training programs to enhance technical skills and knowledge.

Support the training of new lab personnel in hands-on testing procedures.

Provide guidance and on-the-job training to junior quality technicians and production staff.

Promote a culture of continuous improvement by encouraging staff participation in professional development opportunities.

• Regulatory Compliance Support:

Assist in ensuring the lab's operations comply with industry regulations and standards.

Stay updated on changes in regulatory requirements related to packaging testing.

Follow Good Manufacturing Practices (GMP) and maintain compliance with internal quality policies.

What you will bring

• Associate degree or certification in a relevant field (e.g., Packaging Technology, Laboratory Technology).
• 5-7 years of experience in a packaging, laboratory, or medical device environment
• Hands-on experience with package integrity testing methods
• Familiarity with ISO 11607, ASTM, and FDA QSR requirements
• Strong attention to detail and documentation accuracy
• Familiarity with statistical analysis tools
• Ability to follow test protocols precisely
• Excellent documentation skills
• Strong communication and teamwork abilities
• Ability to manage multiple tasks in a lab environment

Working Conditions and Physical Effort

•  Position may include exposure to loud noises from machines and or alarms.
• Position may require from time to time, physical work; heavy lifting, pushing, or pulling required of objects up to 20-25 pounds.
• Work environment may involve some exposure to hazards or physical risks, which will require following basic safety precautions.
• Work may involve moderate exposure to unusual elements, such as extreme temperatures, dirt, dust, fumes, smoke, and/or unpleasant odors
• All required personal protective equipment (PPE) will be provided to ensure a safe working environment.