Sr. Quality Engineer (Wayne, NJ)

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

Job Overview

Provides leadership and technical support for Quality Assurance with an emphasis on providing technical support for the quality assurance team with an emphasis on managing and facilitating monthly Product Quality Data Reviews and quarterly Management Reviews. Leads or is a key contributor to cross functional product/process improvements and problem-solving teams. 

This position reports to the Wayne, NJ headquarters 4 days a week.

Job Responsibilities and Essential Duties

• Supports Quality Management by collecting data for Monthly Metrics and Management Reviews, which includes ensuring that reviews are properly conducted and documented.

• Develops, implements, and monitors various reporting systems concerning product performance and quality to assist top management in problem resolution and decision making.

• Develops, implements, monitors methods and procedures to continuously monitor customer satisfaction, product quality, and compliance with QMS.

• Performs trend analysis and establishes corrective/preventive actions as required.

• May assist Procurement team to develop and implement Supplier Quality metrics.

• May support quality initiatives for improvements to Quality processes, Quality testing, and other areas as identified.

• May investigate product/component issues by conducting failure investigations, complaint trending, and Product Inquiries.

• Other Quality Assurance product/process analysis related duties as assigned.

Required Knowledge, Skills and Abilities

• A Bachelor’s degree in Engineering, Science or equivalent is required.

• A Master of Science Engineering, Science or equivalent is preferred.
• CQE (Certified Quality Engineer) or CSSBB (Certified Six Sigma Black Belt) is preferred.

• A minimum of five years’ experience in quality assurance, quality engineering or related functions or a M.S. plus 3 years’ experience with respect to CAPA process management is required.

• Prior experience in an FDA regulated industry or ISO certified organization.

• Knowledge of quality systems is required. Familiarity with analytical software (i.e., Minitab, etc.) applications is preferred.

• Must be proficient in statistical analysis and have the ability to analyze and solve complex problems.

• Project management and leadership experience is required.

• Excellent oral and technical writing skills with the ability to interface effectively and professionally across departments and at all reporting levels.

• Experience with analytical software (i.e., Minitab) applications is preferred.

• Minimum intermediate skill level ability to use Microsoft Office tools (i.e., Word, Excel, Power Point, or equivalent software applications) is required.

The base salary for the position is a minimum of $100,000 and a maximum of $120,000 plus 10% of base salary in annual bonus

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About us 

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.  

Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.