Quality Engineer, Quality Systems

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.
Essential Duties and Responsibilities of this job

Technical Product Quality Complaints


* 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 Control / Training


* 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.
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