Quality Engineer, Technical Complaints

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, Technical Complaints will provide assistance with all quality system functions with a focus on technical product quality complaint management.  This will include complaint intake, data processing, case tracking, complaint returns, quality investigations, case closeout and customer responses. This role will also support the company quality training system which includes document lifecycle management (SOP creation, review, approval), helping departments author SOPs and understand the training process, tracking employee training completion and follow-up with managers about overdue training. This role will support quality systems for both the USA and Canada.

Essential Duties and Responsibilities of this Job

• 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.

Education & Certifications

• Bachelor’s degree in a Physical Science or Engineering, or equivalent experience is required.

Professional Experience

• 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.
• A quality certification such as ASQ Certified Quality Engineer is considered an asset.

Knowledge, skills & abilities

• 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.

• Prior experience working with electronic quality management systems such as JIRA, MasterControl, TrackWise, Veeva, etc., is considered an asset.

• Experience with quality systems records: CAPA, Deviation, Change Control and prior experience for complaint han