Senior Quality Engineer

Job Description

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! This role will be responsible for management and oversight of their respective products to ensure compliance with regulatory standards and customer and company specifications. The Senior Quality Engineer will be able to effectively assist in troubleshooting issues related to the manufacture of their 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 their products
• Responsible for reviewing and approving investigations for their products 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 their 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.

• Bachelors 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.
• Working in an operational environment
• Experience with investigations, deviations, Non-conformances, CAPAs

The expected compensation range for this position represents a good faith estimate. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate’s relevant knowledge, training, skills, work location, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental, & Vision, Health Savings Accounts, Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences, and 401k Benefits, etc.).

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.