Engineer II, Quality - 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

Partner with Production Engineers, in ensuring compliance to FDA, ISO and other medical device regulations. Reviews current procedures and work instructions to determine compliance by ensuring clarity, accuracy, proper sequencing, and manufacturability.

Job Responsibilities

• Supports Quality management, which includes ensuring that corrective and preventive actions and internal audits findings issued to the department, are properly investigated, documented, effective, and completed on time,
• Communicates, interacts, and coordinates quality improvement efforts for the QCRI Department with QA, R&D, and engineering management.
• Facilitates and consults with corrective action teams in implementing changes to ensure compliance with all applicable QSR / ISO / MDD / CMDR / MDR requirements.
• Supports the creation and maintenance of QCRI-related Standard Operations Procedures and Work Instructions within the Document Management System, including but not limited to Collagen in-process and final QC related procedures.
• Reviews and approves product / process qualification / validation and other change control related documentation.
• Support the Quality Control Receiving Inspection department with day-to-day activities; solve problems, answer questions.
• Maintain department metrology equipment, coordinate monthly equipment submission to the Calibration Lab, procure new equipment as required.
• Purchase requisitions and sample submission activities in support of Collagen in-process testing with 3rd party labs.
• Creation and approval of Certificate of Conformance packages for Collagen customer orders.
• Maintenance and oversight of the Dock to Stock program for approved material.
• Coordinates technical activities regarding validations : including protocol development, synchronization of interdepartmental activities, evaluation, and reporting results
• Supports Supplier management, which includes non-conforming material review and supporting incoming material inspection.
• Supports quality planning by ensuring assigned quality plans and necessary gap assessments are documented, effective, and completed on time.

Minimum Requirements

• Bachelor’s degree in Manufacturing / Industrial, Mechanical, or Biomedical Engineering.
• 2-4 years in manufacturing and / or process engineering required. Experience in the medical device or other FDA regulated industry is preferred.
• Previous working knowledge in some of the following areas is required : continuous improvement processes, Kanban, equipment design, re-tooling, re-engineering and automation of production processes, manufacturing process support, and process development

Salary range : $88k - $98k

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.

Benefits at Getinge :

At Getinge, we offer a comprehensive benefits package, which includes :

• Health, Dental, and Vision insurance benefits
• 401k plan with company match
• Paid Time Off
• Wellness initiative & Health Assistance Resources
• Life Insurance
• Short and Long Term Disability Benefits
• Health and Dependent Care Flexible Spending Accounts
• Commuter Benefits
• Parental and Caregiver Leave
• Tuition Reimbursement

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.

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