Job SummaryThis position will support core quality system processes to ensure compliance with applicable medical device regulations (FDA, ISO 13485) at Warrendale production unit by providing operations support, tracking quality metrics, supporting quality system activities, and analyzing data.
- Support the CAPA, Internal Audit, document control, complaint investigation, and other quality system processes to ensure conformance to applicable regulations, standards, and corporate policies.
- Lead and/or participate in internal audits including scheduling, planning, execution, reporting, and response review and management in a timely manner
- Support 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
- Collaborate 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 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
- Compile, review, analyze, and distribute monthly metric reports for CAPA, Internal Audit, Complaint Investigation, and other quality system processes to identify trends and potential process improvements.
- Ensure effective communication of audit activities, status and metrics to leadership throughout the organization
- Support preparation for and hosting of external audits by regulatory agencies and notified bodies
- Bachelor’s Degree in science or engineering field
- Proficiency with Microsoft Word, Excel, and Power Point.
- Internship or co-op experience in a medical device, pharmaceutical industry preferred.
- Knowledge of quality systems requirements (e.g. 21 CFR Part 820, ISO 13485, MDD, etc.).
- Good verbal and written communication skills.
- Basic analytical, troubleshooting, and problem-solving skills.
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.