Senior Quality Engineer

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

This is an exciting opportunity to join the Kindeva team as a Senior Quality Engineer! The role will be responsible for management and oversight of its products to ensure compliance with regulatory standards and customer and company specifications. A Senior Quality Engineer will assist in troubleshooting issues related to the manufacture of products and drive continuous improvement to the defined processes.

The role involves liaison with Value Stream Engineers, Production Managers, External Customers, Regulatory and Project Teams to provide expert advice on matters relating to the product and manufacturing processes.

• Primary Quality Contact for its products
• Responsible for reviewing and approving investigations and, collaborating 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.; effectively identify, troubleshoot and resolve non-routine problems.
• Participate in New Product Introduction (NPI) activities for its respective customer/product.
• Provide direction and support to Quality Improvement programs using Six Sigma principles.
• Interact with Customers through technical interfaces and audits; be available to discuss quality issues with Customers, in compliance with Quality Agreements and to present Kindeva position.
• Participate in inspection readiness activities and regulatory inspections.
• Review and approval of SOPs, Protocols, Technical Reports, Deviations, CAPAs, planned deviations, change controls, customer complaints, validation and other GMP documentation.

• 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

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.