Quality Assurance Specialist

Quality Assurance Specialist II

Lohmann Therapy Systems North America is seeking a talented Quality Assurance Specialist who will play a crucial role in ensuring the integrity of our quality systems and processes. Your responsibilities will include reviewing operations documentation, managing non-conformance and CAPA systems, and supporting various quality assurance functions.

This is a full-time, on-site role located in West St. Paul, MN.

Shift hours 9:30am-6:00pm (some flexibility); Monday - Friday

Review batch records, operations documentation, and other relevant documents to ensure compliance with cGMP, ISO 13485, EU, FDA regulations, LTS procedures, and customer needs.

Investigate and resolve discrepancies in manufacturing documentation.

Communicate with customers to address their concerns and ensure timely product release. (Complaint investigations).

Implement and manage LTS's Non-conformance and CAPA system.

Support the Material Review Board in resolving non-conformances, customer complaints, and implementing corrective actions.

Provide cross-functional support to Quality, Engineering, Operations, and Purchasing on investigations and corrective action reports.

Initiate and write investigation reports for MRRs and Incidents.

Utilize effective CAPA and Root Cause Analysis tools during investigations.

Provide training and support to colleagues on quality assurance procedures and systems.

Back up other Quality Assurance Specialists and Documentation Specialists as needed.

Author/revise SOPs related to Quality Assurance processes.

Participate in various projects to meet LTS and customer quality requirements.

2-year technical degree required; 4-year technical degree preferred.

2-5 years of Quality Assurance/Quality Control experience in a manufacturing environment, preferably in the medical device or pharmaceutical industry.

2-5 years of experience working in a cGMP regulated environment.

2+ years experience handling complaint investigations

Strong ability to work independently and manage multiple projects simultaneously.

Excellent attention to detail and accuracy.

Knowledge of cGMP, 21 CFR 210, 211, 820, ISO 13485, and other FDA regulations.

Proficiency in MS Office Suite and applicable QMS software.

Effective written and verbal communication skills.

Ability to train and coach others.

Strong problem-solving and analytical skills.

Competitive compensation and benefits package

Opportunities for professional growth and development

A collaborative and supportive work environment

The chance to contribute to improving patient lives

LTS is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.