Principal Engineer, Quality

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

The Principal Quality Engineer provides leadership and technical support for the quality compliance, quality assurance, process control, and engineering functions for the CS business unit. Provides directions in new product development activities related to product design, design validation, design verification, and testing required. Ensures company's design processes are observed. Helps in resolution of issues where precedent may not exist. Leads or is a key contributor to cross functional process improvement and problem-solving teams. Supports the remediation or routine production activities of existing CS product portfolio. This position is an onsite position of 4-5 days in Wayne, NJ.

Job Responsibilities and Essential Duties

• Supports new product design development by providing assistance in the area of Test Method Validation (TMV), design verification and validation, Inspection plan and method, Equipment Installation Qualification, etc.
• Participates in design issues resolution meetings.
• Creates, Reviews, approves product design/process qualification/validation, Design/process remediation, and other change control related documentation.
• Coordinates technical activities regarding validations: including protocol development, synchronization of interdepartmental activities, evaluation and reporting results.
• Supports Quality Control by providing assistance in the area of Equipment Installation Qualification, Test Method Validation, software updates.
• Supports Quality management by ensuring that Corrective and Preventive actions issued are properly investigated, documented, effective, and completed on time.
• Supports Quality management by presenting Non-conforming material data at Monthly Metrics and Quarterly Management Reviews; participating in third party audits; performing Health Hazard Evaluation, reviewing and dispositioning of Non-conforming products.
• Supports Quality Compliance in the performance of internal audits, as needed.
• Supports manufacturing on day-to-day activities.
• Provides support to Supplier Engineering by reviewing First Article documentation.
• Investigates or reviews investigations of equipment Out of Tolerance.
• Identifies and leads implementation of new opportunities for improvements to work processes, production, QA testing, and other areas as identified.
• Communicates, interacts and coordinates quality improvement efforts with Manufacturing, QA, R&D, and Engineering management.
• Provides training to lesser experienced Quality Engineers as needed.

Minimum Requirements

• A Bachelors degree in Engineering, Science or equivalent is required. A Master's of Science in Engineering, Science or equivalent is preferred. CQE (Certified Quality Engineer) or CQA (Certified Quality Auditor) is desirable.
• A minimum of 7 years experience in quality assurance, quality engineering or related functions in an FDA regulated manufacturing environment or a M.S. plus 5 years experience is required.
• 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. Familiarity with analytical software applications is preferred.
• Project management and leadership experience is required. Previous experience supervising technicians and conducting and participating in FDA/customer/corporate audits is preferred.
• Must demonstrate effective influencing and change management skills and demonstrated achievements in process improvements.
• Ability to use Microsoft Office Products such as Word and Excel or equivalent software applications is preferred.

Environmental/Safety/Physical Work Conditions

• Ensures environmental consciousness and safe practices are exhibited in decisions.
• Use of computer and telephone equipment and other related office accessories/devices to complete assignments.
• May work extended hours during peak business cycles.

The base salary for the position is a minimum of $140,000 and a maximum of $150,000 plus annual bonus of 15%

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.