Design and Sustaining Quality Engineer

How will you make an impact?

The Quality Engineer supports the design and development of NP Medical products and processes, sustaining quality engineering activities, and ensuring compliance to quality systems. Develops and implements quality plans, programs, and procedures using quality control statistics, lean manufacturing concepts, and analyzes. Ensures that performance and product quality conform to established company, customer and regulatory requirements. Reviews, analyzes and reports on quality discrepancies related to design and process.

Leads investigation of problems and develops dispositions, modifications, and corrective actions for recurring or non-recurring discrepancies. Interfaces with manufacturing, engineering, customer, vendor and subcontractor representatives to ensure requirements are met. Has primary responsibility for planning and implementing the positions key responsibilities as they apply to new product introduction and sustaining engineering.

• Leads the development, modification, and maintenance of quality evaluation and control plans and protocols for processing materials into partially finished or finished products.
• Leads the development and implementation of methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
• Leads the design and analysis of inspection and testing processes, mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine responsibility for, products or materials that do not meet required standards and specifications.
• Audits quality systems for deficiency identification and correction.
• Leads the process for ensuring that corrective actions (CAPA) are completed in accordance with relevant ISO requirements (ISO 13485), Problem-Solving methods, and that documentation is complete and compliant with requirements.
• May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
• May provide direction and mentoring to less experienced Quality Associates.
• Demonstrated competence in Quality Engineering body of knowledge.
• Writes, reviews, approves process validations/qualifications in accordance with NP Medical and customer requirements.
• Support plant Quality System software validation as needed.
• May manage internal and external (Customer, Notified Body and FDA) quality audits.
• Support all company safety and quality programs and initiatives.
• May perform other duties and responsibilities as assigned.

• Bachelor’s degree in Mechanical, Industrial, Electrical, Biomedical Engineering, or a related field, and/or equivalent combination of education, training and experience.
• 8+ years in Quality, New Product Development, Process or Manufacturing Engineering, in the Medical Device Industry.
• Proficiency in use of computers, Microsoft Office products (Excel, Word and PowerPoint) and e-mail skills required.
• Data skills:
  Excel/Sheets power-user plus basics in a BI tool (Power BI/Tableau/Looker) and the use and development of Pivot tables / charts.
• Root Cause Analysis / Investigation (connected to CAPA and Complaints).
• Ability to influence cross-functional teams and stakeholders using data-driven insights to drive process changes and improvements.
• Hands-on mindset and teamwork orientation, with a willingness to cross train and support different quality areas as needed.
• Demonstrated leadership with teams and projects – with application of strategic planning and accountability of outcome.
• Knowledge / experience in Six Sigma methodologies (DMADV & DMAIC) desired.
• Certifications:
  
  Green belt, Black belt, CQE, certified auditor (ISO 13485) a plus!