Senior Quality Engineer

Senior Quality Engineer Kindeva Drug Delivery Careers - 2.0 Los Angeles, CA Job Details Full-time $113,500 - $125,000 a year 1 hour ago Benefits Health savings account Health insurance Dental insurance 401(k) Flexible spending account Vision insurance Life insurance Qualifications Quality control corrective actions Regulatory inspections 5 years Pharmaceutical regulatory compliance Engineering Six Sigma methodology implementation Corrective and preventive actions (CAPA) GMP Bachelor's degree in engineering Bachelor's degree Continuous improvement Quality audits Quality assurance within manufacturing Manufacturing Root cause analysis Senior level Regulatory audits Manufacturing company experience Regulatory compliance management Documentation reviews Full Job Description Our Work Matters At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. The Impact You Will Make 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.

ROLE RESPONSIBILITIES

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.

BASIC QUALIFICATIONS

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 #LI-Onsite California residents should review our Notice for California Employees and Applicants before applying. 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 does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees—regardless of format—without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.

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. Do you see yourself as part of the Kindeva mission? Click Today!