Job Description

THIS ROLE

• You will be part of a team that is changing the way we think about delivering care in dermatology
• We have a high growth strategy that could lead to advancement opportunities for the right person
• While we are a small organization, we are well-respected by the dermatologists who are aware of our product

RESPONSIBILITIES AND DUTIES

• Define, specify, and implement quality standards and procedures 
• Support the Control of Nonconforming Product and CAPA processes by performing investigations and root cause analysis, determining action plans, and driving the actions to closure
• Prepare corrective action responses, problem solving for permanent corrective actions, and lead problem solving activities
• Responsible for supplier and internal quality system audits as a means of evaluating the effectiveness of the established Quality System and Good Manufacturing Practices
• Track supplier performance relative to quality and delivery issues
• Review and modifies on appropriates device assembly plans including quality checks
• Modifies methodologies and procedures, ensuring continuous improvement of desired outcomes.
• Provides input to management review process 
• Provides technical advice and counsel to cross-functional teams assigned to process improvement projects
• Complete Quality Engineering assignments with minimal supervision.
• Responsible for process validation 
• May perform other duties as required

EDUCATION AND EXPERIENCE

• Electrical or Mechanical engineering bachelor’s degree
• Excellent written and verbal communication skills in English and the ability to interact with members across the organization
• A minimum of 5 -10 years of successful work experience in the medical device field
• Knowledgeable of FDA, QSR cGMP
• Experience in program or project leadership and the associated communication, presentation, team facilitation, and influence management skills
• Strong knowledge of CAD modeling, drawings and machine design with experience in design analyses. Experience with SolidWorks is a plus
• Experience in vendor auditing
• Experience with design and Process Failure Mode and Effects Analysis (PFMA)
• Knowledge, understanding and implementation experience with medical device quality systems, manufacturing operations, supplier quality, and regulatory requirements
• Ability to present, organize and convey problems or issues