Responsibilities:

Support new product development in design control activities such as:

• Execute and document design characterization testing
• Specification development
• Test Method development
• V&V Testing (Write protocols, execute testing, write reports)
• Risk Management
• Change impact assessments
• Maintenance of technical documentation files (e.g., DHF)

Support ongoing Quality System activities

• Lead and document failure analysis investigations (Complaints, product returns and non-conformances raised during manufacturing)
• Perform review of documents for accuracy and correctness.
• Execute CAPA/SCAR investigations, reports and associated actions.
• Internal and external audit support
• Research and qualify new suppliers and vendors
• Conduct training sessions on quality control activities.
• Develop and improve supplier, and in process inspection activities.
• Support documentation requests for product approval in international regions.

Qualifications:

• Advanced Technical Degree or equivalent experience
• 2 years’ related work experience
• Engineering background preferred.
• Experience in testing and failure analysis
• Experience in start-up environment preferred
• Excellent written communication skills