Quality Inspector - Longmont, CO

The Quality Control Inspector is responsible for ensuring that our Class II and Class III medical devices meet all quality standards and regulations throughout the manufacturing process. This person will work closely with the production team and engineers to conduct inspections, ...

Job description

The Quality Control Inspector is responsible for ensuring that our Class II and Class III medical devices meet all quality standards and regulations throughout the manufacturing process. This person will work closely with the production team and engineers to conduct inspections, identify defects, maintain accurate records, and provide feedback for quality improvements.

Organizational Competencies & Cultural Values:

The mission of every employee at Osypka Medtec is dedication to serving, supporting, and improving the lives of our patients and customers by adding value through innovative quality medical devices and services.

Our vision is to be a leading medical company in the development, production, sale, and marketing of permanent and temporary devices and services around the world.

General Competencies:

• Knowledge of quality standards, inspection techniques, and metrology
• Attention to detail
• Read engineering drawings
• Documentation and record keeping
• Problem-solving and time-management
• Excellent communication skills

All employees are expected to provide customer service, communicate in an effective manner both verbally and in writing, display professionalism and integrity, as well as work efficiently, effectively and accurately. Employees should take initiative, solve problems, display good judgment, and take ownership for delivering a high quality product or service.

Essential Job Functions:

• Conduct visual and functional inspections of components and medical devices at various stages of the manufacturing process.
• Use precision measuring equipment and tools – such as calipers, micrometers, gage blocks/pins, measuring microscope, height gage, etc. – to perform detailed measurements and tests on components and finished products.
• Follow established inspection procedures and standards to ensure compliance with regulatory requirements and company specifications.
• Identify and document defects or non-conformities and work with the production team to address and resolve them.
• Perform final inspections and quality checks before products are released for shipment.
• Maintain accurate and detailed records of all inspections and testing results.
• Assist in root cause analysis and participate in corrective and preventive actions when necessary.
• Collaborate with cross-functional teams, including manufacturing, engineering, and quality assurance, to improve product quality and processes.
• Assist with training other personnel on quality procedures and processes.

Education and Experience:

• High school diploma/GED preferred.
• Minimum of 2 years of experience as a quality inspector, medical device or pharmaceutical manufacturing environment, required.
• Strong understanding of FDA regulations and ISO standards for medical devices (ISO 13485:2016).
• Proficiency with precision measuring equipment and tools, such as calipers, micrometers, measuring microscopes, and gauges.
• Proficiency in reading and understanding engineering drawings.
• Excellent attention to detail and ability to identify defects and non-conformities following procedures, work instructions, and other inspections guidelines.
• Knowledge of statistical process control and quality control methodologies.
• Strong communication and interpersonal skills to work effectively with cross-functional teams.
• Ability to work independently and efficiently in a fast-paced and dynamic environment.

Physical Demands:

• Ability to sit or stand for long periods of time.
• Fine motor skills (ability to handle small, delicate items).
• Ability to lift, bend or move up to 20 pounds.

Compensation:

• $22-26 hourly starting salary, depending upon experience
• Paid Vacation
• Paid Holidays
• Paid Sick Leave
• Partial Payment by Company of Group Health, Dental, and Vision Insurance
• 401(k) with limited company matching