Senior Quality Engineer

The Role

This is an exciting opportunity to join the Kindeva team as a Senior Quality Engineer. The Senior Quality Engineer will manage and oversee the products to ensure compliance with regulatory standards and customer and company specifications. They will assist in troubleshooting issues related to the manufacture of products and drive continuous improvement to defined processes.

Role Responsibilities

• Primary Quality Contact for their products
• Review and approve investigations for their products and collaborate with key stakeholders and customers to ensure investigations are closed in a timely manner
• Lead effective root cause analysis / corrective action through use of cause mapping, process mapping, fishbone diagrams, etc.
• Identify, troubleshoot, and resolve non-routine problems
• Participate in New Product Introduction (NPI) activities for their respective customer/product
• Provide direction and support to Quality Improvement programs using Six Sigma principles
• Interact with Customers through technical interfaces and audits
• Discuss quality issues with Customers in compliance with Quality Agreements and present Kindeva position
• Participate in Inspection readiness activities and Regulatory Inspections
• Review and approve SOPs, Protocols, Technical Reports, Deviations, CAPAs, planned deviations, change controls, customer complaints, validation and other GMP documentation

Qualifications

• Bachelor's degree or higher in a science or engineering discipline
• Minimum 5 years' experience within the pharmaceutical or medical device industry
• Ability to work independently, with little or no guidance
• Experience working in an operational environment
• Experience with investigations, deviations, Non-conformances, CAPAs

Benefits

• Medical, Dental, & Vision coverage
• Health Savings Accounts
• Flexible Spending Accounts
• Disability Benefits
• Life Insurance
• Voluntary Benefits
• Paid Absences
• 401(k) Benefits

Equal Opportunity Employer

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.