Job Description

As a leader in the dental industry, Whip Mix is committed to leveraging its technical expertise and manufacturing excellence into practical solutions for dental professionals. Our love for the customer creates a relationship-driven business model that ensures the success of all of our global partners.

Today, more people like you are looking to work for a company that offers real opportunities for personal and professional growth. We invite you to take a closer look at Whip Mix, a leader in the dental industry and a long time champion of employee career paths.

Whip Mix is headquartered in Louisville KY, with a manufacturing facility located in Fort Collins, CO.

Whip Mix Corporation

Louisville, KY

We are seeking a Quality Assurance (QA) Specialist

Pay Range:  $65k - 75k

 

Working under the direction of the Quality Assurance/Regulatory Manager, provide support to establish and maintain the Quality Management System for a medical device manufacturer. Performs internal auditing and follows up on CAPA activity.  Supports quality assurance training and development of quality system documentation and records maintenance.  Administers the Change Control system and monitors production processes for process control and analysis to identify nonconformities and persistent quality issues.

 

Whip Mix team members communicate, act and conduct themselves in a professional and respectful manner that supports the Whip Mix Team First Philosophy and our Values of Loyalty, Passion, Integrity and Versatility.  Within our team approach, team members are encouraged to initiate, cooperate and/or participate fully and as appropriate when solving problems and suggesting improvements that enable the company to live up to its mission and vision.  As part of our team, you will develop a sense of dependability and responsibility amongst your co-workers, operating with enthusiasm and leading by example.  You will make certain that your own assigned tasks are completed satisfactorily and to the standards that are set for the team.  Lean tools, methods and philosophy will be learned, utilized and embraced.  Communication will be given and received freely, frequently, consistently, accurately and professionally.  The priorities of safety 1st, quality 2nd, & production 3rd will be accepted & required. 

 

The job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the team member. Duties, responsibilities and activities may change, or new ones may be assigned at any time with or without notice.

 

 1.  Quality Management System Documentation Develop & update quality management system documentation & records keeping ensuring compliance with the Quality Manual.  Support development of quality procedures such as SOP’s and Work Instructions when required. Aid Quality Assurance/Regulatory Manager in the transition to new standards as they develop. Establish and maintain records as evidence of compliance to quality management system requirements. 20%
2.  Change Management Administers the change management system.  Ensures validation of changes & associated risk analysis are completed and documented. 20%
3.  Corrective and Preventive Action (CAPA) Takes an active role in facilitating the Corrective Action process. Takes initiative in problem-solving for continuous quality improvement relative to raw materials, product testing and product performance. Communicates continuous improvement suggestions to management regarding quality issues and concerns of customers. Submits quarterly CAPA report to management.  20%
4.  Technical Writing – Helps develop technical documentation quality procedures, work instructions, calibration procedures, quality plans and quality related forms. 20%
5.  Process Control – Plans, conducts and oversees test and inspections of materials and products (ex: sampling) to ensure quality is maintained. 10%
6.  Quality System Auditing Leads internal audits, documents findings and works with departments to provide effective corrective action.  Participates in external audits.10%
7.  Performs other functions or duties as assigned.  0%

 

 

 

1.       Proficient in MS Office, as well as demonstrated knowledge of ISO 13485 and Quality Management Systems (QMS). 

2.       Excellent technical writing skills and attention to detail.

3.       Communication skills necessary to interact successfully within a team framework.

4.       Ability to run statistical analysis and prepare charts and graphs (using statistical and graphics packages), sampling methods, metrology and calibration programs, ERP systems and the internet. 

5.       Able to read and understand manufacturing orders and complex work instructions, and material handling documents. 

6.       Must be an organized self-starter with very strong decision making ability. Able to prioritize work and meet deadlines.

 

Typical laboratory setting with daily exposure to the potential hazards of working with chemicals and chemical by-products, especially the daily use of silica and nuisance dust-containing products.

Daily exposure to the noise levels and potential dangers of tools and equipment in a typical machine shop environment.