Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

How will you make an impact?

The Quality Engineer II will lead investigations, development of investigation plans and assist in development of corrective action plans of quality issues related to customer complaints, corrective action requests and quality improvement requests.  Collaborate with customers regularly to ensure products meet expectations.

What will you do?             

Lead multi-functional team members supporting the Customer Feedback/Complaint Handling Process & CAPA process.Lead multi-functional team members supporting internal investigations (NCM, UD) & CAPA processMonitor product quality improvement to ensure execution of actions including any resulting customer communications/interactions.Complete Risk and Impact AssessmentsInterface directly with customers and internal groups.Develop realistic solutions to meet customer needs and solve problemsStrong Root Cause / Corrective Action skills.Drive product and process changes to improve product quality. The ability to perform independently and as part of a team.  Must be able to influence and negotiate with people and resolve issues.  Communicate recommendations and decisions across the organization. Experience with problem solving tools (8D, 5-whys, cause and effect, etc).Demonstrated ability to lead in a fast-paced technical environment, absorb technical information, review technical information and make technical decisions.

How will you get here?

Bachelor’s degree in Engineering field or 5 years direct Quality Engineering experience.5 years’ experience in medical device, biotech or pharmaceutical industry in an Engineering, Quality or Regulatory related role.Direct experience of working with ISO 13485 or ISO 9001 and 21CFR820

Knowledge, Skills, Abilities

Strong analytical, problem solving, and teamwork skills are required.Experience at effectively communicating complaints, risks, production, process controls, Corrective and Preventive Action (CAPA) and improvements.Ability to analyze and process data and draw the appropriate conclusions.Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies, in-depth understanding of products and processesUnderstanding of plastics- materials, properties, manufacturing processes, and product assembly.Experience prioritizing conflicting demandsExcellent interpersonal, organizational, and influencing skillsAbility to analyze and process data, and draw the appropriate conclusionsExperience working with multi-functional teams and facilitating teams to identify and implement solutions to complex problemsExcellent communication, written and presentation skills. Proficient with Microsoft tools; Word, Excel, Power Point, Visio, Teams; MiniTab.ASQ certification is desired.