Quality Engineer, Quality Systems

Merz Therapeutics•Raleigh, NC

10h•Onsite

About The Position

Step into the future with us at Merz Therapeutics, where our family roots meet a bold new vision. Together, we’re embarking on a transformative journey, blending time-honored traditions with exciting new products. As a private, family-owned company, we have the liberty and support to make decisions for ourselves, our customers and the patients we serve. We pride ourselves on building an inclusive culture where there is room to celebrate individual growth with the ability to contribute to a common good as a collaborative team. Our mission is grounded in a long-term view of making a difference for the common good, while growing together as a family. If you‘re looking to immerse yourself in a passionate team rooted in community, connection and camaraderie, then we’re looking for YOU! #IAmMerz Are you ready to galvanize a team around a culture of care, putting patients first to spark change? The Quality Engineer, Quality Systems will provide support for quality system functions with a focus on technical product quality complaint management. Responsibilities include complaint intake, data processing, case tracking, complaint returns, investigations, case closeout, and customer responses. This role will also support the company's quality training and document control systems, including document lifecycle management, employee training administration, and assistance to departments in authoring and maintaining controlled documents.

Requirements

Minimum 3 years of experience in the pharmaceutical industry is required, preferably within a Quality Assurance or Quality Systems 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, including CAPA, Deviations, Change Controls and 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.

Nice To Haves

A quality certification such as ASQ Certified Quality Engineer is considered an asset.
Experience creating and maintaining quality metrics dashboards, analyzing trends, and communicating performance data through graphical presentations using tools such as Power BI, Tableau, Excel, or equivalent business intelligence platforms is considered an asset.
Prior experience working with electronic quality management systems such as JIRA, MasterControl, TrackWise, Veeva, etc., is considered an asset.

Responsibilities

Complaint intake
Data processing
Case tracking
Complaint returns and product replacements or credits
Complaint investigations for local products
Case closeout and customer responses.
Perform monthly reconciliations of complaint data received from external partners and internal stakeholders to ensure the completeness, accuracy, and regulatory compliance of complaint records and associated quality system documentation.
Monitor the Quality Complaint Inbox daily.
Assist with the preparation and implementation of Quality Assurance policies and procedures.
Complaints trending and metrics reporting.
Communicate with patients, customers, and other relevant parties to obtain and document information necessary to support technical product quality complaint investigations and ensure complete and accurate complaint records.
Document lifecycle management (SOP creation, review, approval)
Assist departments with authoring SOPs, understanding document and training processes, monitoring training assignments, and following up on overdue training.
Assist with preparing and implementing Quality Assurance policies and procedures.
Track employee training completion and follow up with managers regarding overdue training, training assignments, and document routing activities.
Monitor the Document Control Inbox daily.
Serve as a liaison between Merz Tx and the Global Team, facilitating effective communication, collaboration, and alignment on quality system activities and initiatives.
Support the administration of Quality System processes related to deviations, CAPAs, and associated tracking and implementation activities.
Support Quality System processes and initiatives to maintain compliance with company procedures and applicable regulatory requirements.
Assist with quality metrics, trend analysis, and Quality Management Review activities.
Participate in continuous improvement projects and quality system enhancement initiatives.
Assist with Quality System inspections, regulatory audits, and internal audits.
Support adherence to Quality Assurance performance indicators and quality system requirements.
Participate in quality team meetings and Quality Management Review activities.
Collaborate with Quality, Regulatory Affairs, Safety, and other cross-functional teams.
Participate in quality improvement initiatives and cross-functional projects.
Maintain compliance with the Global Therapeutics Quality Management System.
Support Merz Therapeutics U.S. and Canadian product recall activities, including process execution, communications, and reporting requirements.
Supporting local leadership in any quality objectives as applicable, staying up to date on SOP reading/training requirements and notifying manager of regulatory compliance about overdue training.