Sr. Quality Engineer, Ops (Wayne, NJ)

Getinge•Wayne, NJ

7d•$115,000 - $120,000•Hybrid

About The Position

The Senior Quality Engineer is responsible for implementation and execution of Quality Engineering functions, ensuring the effective establishment and maintenance of quality systems.

Requirements

Bachelor’s degree in engineering, Science or equivalent is required.
A minimum of five years’ experience in quality assurance, quality engineering or related functions or a M.S. plus 3 years’ experience is required.
Prior experience in an FDA regulated industry or ISO certified organization
Must have demonstrated proficiency in statistical analysis, the ability to analyze and solve complex problems, and the ability to communicate effectively across departments.
Working knowledge of quality systems is required.
Project management and leadership experience is required.
Must demonstrate effective influencing and change management skills and demonstrated achievements in process improvements.
Knowledge of Microsoft Office Products such as Word, Excel or equivalent software applications

Nice To Haves

A Master of Science in Engineering, Science or equivalent is preferred.
CQE (Certified Quality Engineer) or CQA (Certified Quality Auditor) is desirable.
Familiarity with analytical software applications is preferred.
Previous experience supervising technicians and conducting and participating in FDA/customer/corporate audits is preferred.

Responsibilities

Leads quality planning by ensuring assigned quality plans and necessary gap assessment are documented, effective, and completed on time.
Leads Quality management activities, which includes ensuring that corrective and preventive actions are issued as required, properly investigated, documented, effective, and completed on time.
Run the Material Review Board Meeting by providing and/or reviewing data to be presented for escalations of non-conforming material records.
Supports Supplier management, which includes non-conforming material review and supporting incoming material inspection.
Coordinates technical activities regarding validations: including protocol development, synchronization of interdepartmental activities, evaluation, and reporting results.
Leads communications, interacts, and coordinates quality improvement efforts with Manufacturing, QA, R&D, and engineering management regarding product status, deviations, and problems; provides testing and training support to Manufacturing, Engineering and R&D
Reviews and approves product/process qualification/validation and other change control related documentation.
Identifies and leads implementation of new opportunities for improvements to work processes, production, QA testing, and other areas as identified.
Investigates product issues by conducting failure investigations within the NCMR process.
Facilitates the investigation of component issues with Engineering, as needed.
Support the Health and Hazard Evaluation process by gathering required data and performing in-depth analysis prior to sharing the information with the Field Action Committee
Lead and support CAPA related activities.
Provide mentorship and guidance to new Engineers/Interns within the organization.