Company Description:

BASIC PURPOSE OF POSITION:
 
The Sr. Quality Engineer supports Solar Gard with tasks associated in evaluating the quality of company products, processes and the effectiveness of the SOLAR GARD quality management system. Provide expertise in the areas of Quality Assurance, Healthcare Compliance, Design Controls, and Risk Management. The Sr. Quality Engineer must be able to work with limited supervision and effectively complete projects associated with the evaluation of product and process quality.  Responsibilities include the resolution of customer and supplier quality problems,  routine quality lab functions, understanding of ISO 9001:2015, product and customer quality audits, completion of MRB tasks, and the timely generation of all required customer certifications.  The Sr. Quality Engineer must be able to apply detailed statistical analysis of data, TQM, design and execute DOEs and MSAs and establish sampling methodologies. Methods include Six Sigma tools to improve internal and external processes at SOLAR GARD, its suppliers, and customers.  The Sr. Quality Engineer must communicate effectively within the company as well as with customers and suppliers.  Facilitate in a team environment to solve problems while working in a multi-task environment. Mentor the quality engineers assisting them to achieve key deliverables for their role.
 
ESSENTIAL FUNCTIONS OF THE POSITION:
 

1. Facilitate internal, customer, and supplier audits including ISO 9001:2015 audits.
2. Participates in the Material Review Board functions.
3. Audits quality tests performed within the company to ensure accuracy and consistency.
4. Acts as a liaison between the company and customers or suppliers to ensure that clear specifications and quality standards are defined and understood. 
5. Coaches and trains SOLAR GARD employees, suppliers and customers on effective and appropriate Total Quality Management methods, execution of Quality Plans and product specifications.
6. Lead problem solving investigations for product failures encountered during standard production or in new product development.
7. Ensures Quality Engineering support and analysis of customer complaint investigations as required.
8. Perform tests and or review data submitted by others to generate Certificates of Conformance for Solar Gard products.
9. Assists in the planning and utilization of Quality Department resources to complete tasks such as lab testing or the support of new raw material qualifications.
10. Train company employees to perform quality tests and evaluate test results.
11. Writes procedures or documents as directed by the Quality Manager.
12. Understands ISO 9001:2015 procedural requirements.
13. Supports process improvement actions utilizing TQM methods and Six Sigma tools.
14. Reviews ECN’s to ensure compliance to the Solar Gard Quality System, and International requirements for New Product Development (NPD).
15. Provide authoritative guidance about Six Sigma principles (sampling, acceptance criteria, DOE, SPC, root cause analysis, FMEA, control charts, capability analysis) as well as guidance on design control elements to NPD team members and production personnel.
16. Advise on the development and execution of verification/validation plans and protocols associated with product/process quality according to Solar Gard Stage Gate and Solar Gard SOPs.
17. Able to lead DFMEA and PFMEA sessions as required
18. Support design control and process validation activities for new and qualification efforts.
19. Effective and efficient use of Quality Engineering techniques such as risk analysis, test method development, statistical data analysis.

 
 
ESSENTIAL REQUIREMENTS FOR THE POSITION:
 

1. Solid understanding of Quality planning, control, assurance, and improvement.
2. Strong coaching / facilitating skills with individuals and teams.
3. Written and verbal skills including the ability to read and write specifications, tests and procedures in English and legible handwriting are required.
4. Computer literacy in MS Word, PowerPoint, and Excel to include Vlookup and Pivot Tables. Database management, SAP and Minitab usage is a plus
5. This position may require shifts that include weekend or second/third shift assignments as well as travel.
6. Capable of presenting results and conclusions to senior management of SOLAR GARD, customer and suppliers.
7. BS required preferred in Chemical Eng., Mechanical Eng., Industrial Eng. or Material Science and eight years of Quality Engineering or related experience.
8. 5+ years of experience on web handling, mixing, coating, drying, metalizing and slitting processes preferred
9. 5+ years of experience applying lean Manufacturing and Six Sigma Principles with process validation/process capability
10. ASQ CQE preferred with demonstrated experience in resolving significant business problems.
11. Utilizes advance project management tools to keep track of activities, delivering frequent updates and requesting assistance when needed.
12. Vision equal to or correctable to 20/20 with no color-blindness is required.
13. 4 years of work experience in FDA regulated industry for Medical Devices, Biologics, or Pharmaceuticals is required with 2 of those years in a Quality Engineering role is preferred
14. New product development experience is preferred.