Senior Quality Engineer

Required :

• A Bachelor’s degree in Engineering, Biology, Science, Chemistry, or related technical field is required.
• Minimum of 4 years work experience in a regulated industry (medical device, biopharmaceutical, or pharmaceutical).
• Fundamental understanding of the Quality Systems Regulations (QSR), including Design Control, and Good Manufacturing Practices (GMP).
• Strong verbal and written communication skills are required including ability to develop and present to leadership.
• Applied experience with documentation and technical writing skills, in a regulated compliance environment.
• Strong collaboration and teaming skills in a diverse team environment is essential.
• Demonstrated high initiative and self-starter

Preferred

• Advanced Degree
• Prior experience in a Quality / Quality Engineering role.
• Fundamental understanding of the pharmaceutical GMPs.
• Experience in statistical analysis and statistical analysis tools such as Minitab is preferred.
• Experience in applying various risk management and risk mitigation tools.
• Experience with Test Method Validations, Root Cause Analysis, CAPA & Non-Conformance Management, and Process Validations.

Location : Somerset County, New Jersey.

Candidate should be available to work from the site for at least three days.

Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.