Merz Therapeutics · 14 hours ago
Quality Engineer, Technical Complaints
Raleigh, North Carolina, United States
Full-time
Onsite
Mid Level
3+ years expMerz Therapeutics is a private, family-owned company focused on making a difference through quality healthcare products. The Quality Engineer, Technical Complaints will manage technical product quality complaints, document control, and quality improvement processes while ensuring compliance with quality systems for both the USA and Canada.
Biotechnology
Responsibilities
Technical Product Quality Complaints: Complaint intake, data processing, case tracking, complaint returns a product replacements/credits, conducting Technical Complaint Investigations, case closeout and customer responses
Document Control: Document lifecycle management (SOP creation, review, approval), helping departments author SOPs and understand the training process, tracking employee training completion and following-up with managers about overdue training, preparing and implementing Quality Assurance policies and procedures
Deviations, CAPAs: drive the operation of the Quality System process related to capturing data associated with deviations, Corrective actions/preventive action tracking and implementation
Process Improvement: Promote Quality Improvement processes
Inspections and internal audits: Assist with all related Quality System Inspections and internal audits
Quality Assurance Diligence: adhering to QA key performance indicators (staying on top of deviation investigations and closure, CAPA actions and closure, Change Control actions and closure, etc.), authoring/reviewing SOPs, contributing to Quality Management Reviews and quality team meetings, collaborating with local and global quality, safety, regulatory teams, participating in cross-functional projects, driving quality improvement activities, building a company culture of quality through training and quality initiatives, maintaining compliance with Global Therapeutics Quality Management System
Additional responsibilities as assigned: supporting local leadership in any quality objectives as applicable, staying up to date on SOP reading/training requirements, notifying manager of regulatory compliance questions and issues, backup to team members as needed, etc
Adhering to company adverse event and complaint reporting requirements
Qualification
Required
Bachelor's degree in a Physical Science or Engineering, or equivalent experience is required
Minimum 3 years of experience in the pharmaceutical industry is required, preferrably in a quality assurance function
Experience working in and with different people and organizational cultures, supporting people with diverse backgrounds, attitudes and cultural differences
Working knowledge of GMP, GDP, and Canadian Food And Drug Regulations
Ability to communicate with Regulatory and Quality personnel
Must be proficient in Microsoft Office applications including Word, Excel and PowerPoint
Experience with quality systems records: CAPA, Deviation, Change Control and prior experience for complaint handling
Strong interpersonal, collaborative, organizational skills and ability to multi-task
Fluency in English and excellent verbal and written communication skills
Commitment to quality practices and principles
Preferred
A quality certification such as ASQ Certified Quality Engineer is considered an asset
Prior experience working with electronic quality management systems such as JIRA, MasterControl, TrackWise, Veeva, etc., is considered an asset
Company
Merz Therapeutics
Merz Therapeutics GmbH is dedicated to delivering better outcomes for more patients.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Philip Burchard
Chief Executive Officer
Recent News
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