Fresenius Kabi is a global health care company that specializes in lifesaving medicines and medical technologies for infusion, transfusion and clinical nutrition. Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients. We are part of Fresenius SE, a health care group with more than 100 years of experience in pharmaceuticals, medical devices and life sciences. Our employees – more than 30,000 worldwide – develop and deliver injectable pharmaceuticals and infusion systems; blood collection, transfusion and cell technologies; and essential nutrients for parenteral nutrition.
Whether you work for us, buy from us, partner with us, or invest in us, you will come to know that caring is at the core of everything we do. Our purpose is to put lifesaving medicines and technologies in the hands of people who care for patients, and to find answers to the challenges they face every day.
We currently have an opportunity for a Quality Engineer in our Warrendale, PA manufacturing facility who will support core quality system processes to ensure compliance with applicable medical device regulations (FDA, EU, Health Canada, ISO 13485) by providing operations support, tracking quality metrics, facilitating training programs, reviewing quality system records, and analyzing data.
- Supports the CAPA, Internal Audit, document control, complaint investigation, and other quality system processes to ensure conformance to applicable regulations, standards, and corporate policies.
- Leads and/or participates in internal audits including scheduling, planning, execution, reporting, and response review and management in a timely manner
- Conducts in-depth audits of Quality System elements against internal and external requirements including regulatory requirements, industry standards, regulatory guidance documents, corporate policies and standard operating procedures, and local procedures, documents, and records
- Provide support for regulatory compliance processes such as Product Field Action assessments and execution.
- Collaborates with other departments and cross-functional teams on daily tasks and projects, such as CAPA records complaint investigations, and internal audit reports/ responses.
- Initiate and manage CAPA records and facilitate board meetings to ensure on-time completion & escalation as needed.
- Work cross-functionally to lead investigations teams and root cause analyses and provide well-documented corrective and preventive action plans for identified issues
- Compiles, reviews, analyzes, and distributes monthly metric reports for CAPA, Internal Audit, Complaint Investigation , and other quality system processes to identify trends and potential process improvements.
- Ensures effective communication of audit activities, status and metrics to leadership throughout the organization
- Supports preparation for and hosting of external audits by regulatory agencies and notified bodies
- Ensuring that change initiators/reviewers have identified the appropriate employees for process training, and that training is conducted timely and documented appropriately.
- Bachelor degree in science or engineering field.
- A minimum of 3 years in a Quality role.
- Proficiency with Microsoft Word, Excel, and Power Point
- 5 years' experience in medical device, pharmaceutical industry preferred.
- ASQ Certified Quality Auditor, Certified Biomedical Auditor and/or ISO 13485 Lead Auditor certification preferred.
- Knowledge of quality systems requirements (e.g. 21 CFR Part 820, ISO 13485, MDD, etc.).
- Good verbal and written communication skills.
- Basic analytical, trouble-shooting, and problem solving skills.