Duties:

· Use appropriate measuring tools and equipment to verify dimensional and functional requirements during product qualification and throughout the manufacturing process.

· Ensure monitoring and measuring equipment is calibrated and schedule recalibration services.

· Control and investigate potential quality defects, including conducting root cause analysis and providing written reports.

· Facilitate the implementation of corrective actions and preventive actions.

· Provide support to the Manufacturing Engineer and Biomechanical Engineer during validation activities.

· Provide support to Manufacturing and Engineering for improvements to processes and product evaluations.

· Ensure procedures, templates, and records are maintained, accurate, controlled, and updated when necessary.

· Collect and report data specific to process and product monitoring.

· Assist with internal and external audit support.

· Other Quality related duties as assigned.

Education/Experience:

· High school diploma; Associates Degree in a Quality or Manufacturing field preferred.

· Minimum of two years of Quality experience in a manufacturing setting.

Qualifications/Skills/Knowledge

· Proficient in Microsoft Office programs, Word, Excel, PowerPoint, Outlook.

· Effective written and oral communication skills.

· Excellent attention to detail and ability to keep accurate records and files.

· General knowledge in use of standard inspection equipment and basic hand tools, such as: calipers, micrometers, pin gages, go and no/go gages, and vision equipment.

· General familiarity with ISO 13485, FDA Quality System Regulations, and current Good Manufacturing Practices (cGMP) or Good Laboratory Practices (GLP).

· General knowledge in problem solving and decision-making skills, and the ability to think independently.

· Ability to collaborate and work well with others.

Job Type: Full-time

Pay: $50,000.00 - $55,000.00 per year

Benefits:

• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Retirement plan
• Vision insurance

Experience level:

• 2 years

Schedule:

• 8 hour shift
• Holidays
• Monday to Friday

Work setting:

• In-person
• Manufacturing facility

Work Location: In person