Senior Quality Engineer - Life-Saving Ops, Hybrid

Getinge; Wayne (NJ); Hybrid; USD 115,000 - 120,000; Full time

Benefits offered by this job

Annual bonus 10%

Hybrid work model

Health benefits

Job summary

Getinge in Wayne, NJ is seeking a Senior Quality Engineer responsible for implementing and executing Quality Engineering functions, ensuring quality systems are established and maintained.

You will lead quality planning, CAPA, supplier management, validations, and risk assessments while collaborating with Manufacturing, QA, R&D, and Engineering.

This role requires extensive QA experience in regulated industries, strong statistical skills, and mentorship to junior engineers; hybrid work model.

Qualifications

• Bachelor's degree in engineering or science, MS preferred.
• Minimum five years in quality assurance/engineering or MS with 3 years.
• FDA-regulated or ISO-certified experience preferred.
• Strong statistical analysis and problem-solving skills.
• Proficient in MS Office and quality systems knowledge.
• Experience leading CAPA, audits, and cross-functional teams.

Responsibilities

• Lead quality planning and ensure timely documentation of gap assessments.
• Drive CAPA activities and corrective actions; ensure effectiveness.
• Run Material Review Board and review non-conforming material.
• Support supplier management and incoming material inspection.
• Coordinate validations and protocol development across departments.
• Lead communications with Manufacturing, QA, R&D and engineering.
• Review and approve qualification/validation documents.
• Identify opportunities to improve processes and work flows.
• Investigate product issues via NCMR; coordinate with Engineering.
• Mentor engineers and interns.

Skills

Quality assurance

Quality engineering

Statistical analysis

Cross-functional collaboration

Problem solving

Project management

Audit & CAPA

Education

Bachelor's degree in engineering, Science or equivalent

Master of Science in Engineering, Science or equivalent

CQE or CQA certification desirable

Job description

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

Job Responsibilities and Essential Duties

• 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.

Required Knowledge, Skills, and Abilities

• Bachelor's degree in engineering, Science or equivalent is required. A Master of Science in Engineering, Science or equivalent is preferred. CQE (Certified Quality Engineer) or CQA (Certified Quality Auditor) is desirable.


• 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. 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.


• Knowledge of Microsoft Office Products such as Word, Excel or equivalent software applications

The base salary for the position is a minimum of $115, 000 and a maximum of 120,000 plus an annual bonus of 10%

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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.