Quality Engineer, Technical Complaints

Step into the future with us at Merz Therapeutics where our family roots meet a bold new vision. Together were 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 youre looking to immerse yourself in a passionate team rooted in community connection and camaraderie then were 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

• Bachelors 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 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.

Travel Requirements

Travel is minimal for this role. There may be an occasional travel opportunity for a training conference or visit to the Canadian site once in a while.

Recruitment Note: Merz Therapeutics only sends emails from verified addresses and never asks for sensitive personal information or money. If you have any doubts about the authenticity of any type of communication from or on behalf of Merz Therapeutics please contact

Required Experience:

IC