Description

Splintek is a Lenexa based, made in the USA manufacturing company in the business of providing high-quality healthcare products to Retailers, Professionals and direct to consumers since 1996. Innovation, team-based, high energy, casual business environment. Splintek’s mission is to enhance the quality of life globally by innovating healthcare products for better sleep, more comfort, and overall health. Please visit our website at www.sleepright.com

PRIMARY OBJECTIVE OF POSITION

Execute and aid company departments on a current Quality Control Protocol and ensure its annual update and approval according to government regulations. Evaluate existing procedures, recommend revisions, and conduct internal audits to ensure compliance with GMP regulations. Provide support for new product projects and coordinate with development and production teams. Test and trouble shoot new product development materials and methods and spearhead compliance issues.

DUTIES AND RESPONSIBILITIES / ESSENTIAL FUNCTIONS

• Execute a Quality Control Protocol and ensure it’s annual update and approval according to government regulations.
• Provide Support for new projects and coordinate with the production team and personnel to trouble shoot licensing or compliance issues. 
• Evaluate existing procedures, recommend revisions, and conduct internal audits to ensure compliance with regulations.
• Conduct risk assessment and corrective action solutions. 
• Perform routine testing to ensure quality and adherence to regulations and standards. 
• Participate in process reviews to inform development of product issues and resolutions.
• Improve Quality, ensure safety improvements in product specification.
• Maintain and disseminate quality manuals and other documentation. 
• Work with other members of the organization in the design and development of new products.
• Develop and maintain quality control processes. 
• Perform and coordinate inspections and determine quality assurance testing models of raw materials and finished products.
• Verify logs, databases, and other data to track and flag quality concerns and improvements.
• Organize and facilitate quarterly Managers Meetings.
• Support the development and implementation of improved quality reporting measures. 
• Carry out annual product reviews. 
• Support quality related customer complaint investigation and trending activities. 
• Supervise and review analytical work, research projects, and production formulations and products 
• Adhere to all GMP/GLP requirements.
• Maintain calibration program for lab instruments and production scales 
• Ensure company compliance with EPA, FDA, and OSHA regulations 
• Perform Quality Control testing on raw materials, intermediate, and finished products using established analytical procedures and methods 
• Make safety a priority consideration with all actions taken and ensure that safe work practices are followed and adhered to

Requirements

EDUCATION

REQUIRED:

• Bachelor’s degree in Polymer Chemistry, Plastics Technology or related field 

EXPERIENCE AND SKILL

REQUIRED:

• Good working knowledge of plastics technology and processing
• Familiarity with thermoplastic polymers and polymer chemistry and injection molding 
• Excellent oral and written communication skills 
• Proficient in spoken and written English 
• Microsoft Office Suite and web research

PREFERED:

• 3 years of laboratory or quality assurance experience 
• GMP Compliance 
• Internal Audit 
• Quality Assurance 
• Writing maintaining Procedure & Documentation 
• Familiarity with thermoplastic polymers and polymer chemistry and injection molding 
• Familiarity with ICH guidelines and cGMP and GLP regulations 
• Familiarity with FDA regulations for medical devices. 

WORK ENVIRONMENT AND PHYSICAL DEMANDS

Vision: Use vision to read, write, type, operate office, electronic, and manufacturing equipment, and make fine adjustments.

Speaking/Hearing: Give and receive information through speaking and hearing.

Motor Coordination: Requires hands to operate equipment.

Lift/Carry: Regularly lift, push, and move up to 50lbs.

Environment: Office and warehouse environments are new and clean and well lit. Facility complies with all safety standards and is climate controlled.