ENGINEER (Quality)

Job Summary

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.

Requirements

• B.S. Degree in Engineering (Mechanical, Electrical, Biomedical preferred).
• Proficiency with Microsoft Word, Power Point, Excel.
• 0-3 Years experience in the Medical Device or Pharmaceutical industry preferred.
• Knowledge of Lean Manufacturing, Six Sigma and Project Management principles a plus.
• Knowledge of Quality System 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.
• Excellent written and verbal communication skills.
• 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 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, citizenship, immigration status, disabilities, or protected veteran status.