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Quality Engineer

5 months ago

Raleigh, United States Merz Therapeutics Full time
This role is based in our Raleigh, North Carolina Corporate Office

Who We Are: Harvesting Hope with a Growing Family

At Merz Therapeutics, we take a nurturing approach to our organization - treating colleagues like family, embracing our whole selves and creating a company culture that encourages growth and decisive action. We are committed to caring for whole communities by focusing on individuals suffering from movement disorders and neurological conditions and the healthcare providers dedicated to helping them, while simultaneously bolstering our team members in a united effort to make a difference.

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.

The Quality Engineer 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.

The role will also provide assistance with document control, records control and training including facilitating change control and training.

If you're looking to immerse yourself in a passionate team rooted in community, connection and camaraderie, then we're looking for YOU #IAmMerzTx

Are you ready to galvanize a team around a culture of care, putting patients first to spark change?

Core Duties

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.
  • Complaints trending activities, monitoring metrics
Training
  • Creation and Implementation of the Merz Therapeutics Quality System Training Program and ensuring all training is completed on time
  • Tracking employee training completion and following-up with managers about overdue training.
Document Control
  • Preparing and implementing Quality Assurance policies and procedures
  • Document lifecycle management (SOP creation, review, approval), helping departments author SOPs and understand the training process
Nonconformances
  • Drive the operation of the Quality System process related to Corrective/Preventive actions and nonconformance control, including capturing data associated with product deviations, nonconformances, CAPAs and complaints and analyzing the data for the reasons of Quality Improvement and reporting
Process Improvement
  • Promote Quality Improvement processes
Inspections
  • Assist with all related Quality System Inspections
Compliance
  • Assist with adherence to all Federal, State and Local Regulations controlling the manufacture of medical device and drugs
  • Provide support within the Quality department and to other Merz Therapeutics departments as directed by Quality Management.
Education

Bachelor's degree in a Physical Science or Engineering, or equivalent experience is Required

Professional experience
  • Minimum 5 years Quality Assurance Pharmaceutical, Medical Device and/or other regulated industry or similar experience is Preferred
  • ASQ Certification as a Quality Engineer is Preferred
  • Experience working in and with different people and organizational cultures, supporting people with diverse backgrounds, attitudes and cultural difference is Preferred


Don't meet every single requirement? Studies have shown that women and people of color are less likely to apply to jobs unless they meet every single qualification. At Merz Therapeutics we are dedicated to building a diverse, inclusive, and authentic workplace, so if you're excited about this role but your past experience doesn't align perfectly with every qualification in the job description, we encourage you to apply anyways. You may be just the right candidate for this or other roles.

Recruitment Note:Merz Therapeutics only sends emails from verified "merz.com" 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 Therapeutics.HR@merz.com

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)