New

Quality Engineer

Fresenius Kabi USA, LLC
$70,000.00 to $75,000.00 Per Year
life insurance, 401(k)
United States, Pennsylvania, Warrendale
770 Commonwealth Drive (Show on map)
Oct 22, 2025
Job Summary This position does not support employment visa sponsorship now or in the future. Applicants who currently hold or will require sponsorship (including upon expiration of their current authorization) are not eligible for this role. This is an ON-SITE role, and does not provide remote or hybrid work capability. Salary Range: $70,000.00 to $75,000.00 Per Year Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, abilities and working shift. Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision. This position will analyze and execute processes to ensure product quality in the Production Unit (PU). This position will support core quality system processes to ensure compliance with applicable medical device regulations and standards (FDA, EU, Health Canada, ISO 13485) by providing operations assistance, tracking quality metrics, reviewing and approving quality system records, and analyzing data. Requires working in a cross-functional team environment. Applies engineering principles to resolve difficult problems. Responsibilities Provides Quality support for the organization's product development initiatives and manufacturing operations by performing the following: ensuring design transfer compliance through active team membership, managing the change order process, and providing quality engineering support for device manufacturing. Initiates and manages CAPA records, collaborates with other departments and cross-functional teams to support investigations and root cause analyses, and provides well-documented corrective and preventive action plans for identified issues. Supports and/or participates in internal and external audits, including scheduling, planning, execution, reporting, and response review in a timely manner. Supports in-depth audits of Quality System elements against internal and external requirements, including regulatory requirements, industry standards, regulatory guidance documents, corporate policies, standard operating procedures, and local procedures. Compiles, reviews, analyzes, and distributes various quality metrics, including CAPA, change order, and other quality system processes to identify trends and potential process improvements. Provides support for regulatory compliance processes, such as Field Corrective Action assessments and execution. Collaborates with other departments and cross-functional teams on daily tasks and projects. Ensures compliance to regulatory requirements, upholds the Quality Management System (QMS). Utilizes project management skills to coordinate activities for multiple projects to ensure timely completion in support of corporate, plant, and/or departmental goals. Performs all other duties as assigned. All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities. REQUIREMENTS B.S. degree in Engineering (Mechanical, Electrical, Biomedical preferred). Proficiency with Microsoft Word, Excel, and PowerPoint. 0-3 years of experience in the medical device or pharmaceutical industry preferred (quality engineering and/or product development experience a plus). 1 year experience preferred. Knowledge of lean manufacturing, Six Sigma, and Project Management principles a plus. Knowledge of quality systems requirements (e.g. 21 CFR Part 820, ISO 13485, etc.) a plus. Knowledge of quality control processes and statistical techniques. Strong analytical problem-solving skills. Strong attention to detail. Excellent verbal and written communication skills. Strong interpersonal skills and the ability to work with cross-functional teams. Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness 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, citizenship, immigration status, disabilities, or protected veteran status.