Senior Quality Engineer (Wayne, NJ) Defined Term

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 effective establishment and maintenance of quality systems. Leads efforts to sustain and enhance Quality Compliance, maintenance of quality systems, preparation/revision of QMS Procedures to sustain compliance.

This position is a Defined Term position for a period of one year.

Work location is Wayne, NJ where the position is 4 days a week onsite.

Job Responsibilities and Essential Duties

• Review Quality Manual to identify potential gaps in documented quality processes (including outsourced processes), procedures to ensure compliance to ISO13485:2016, MDSAP, and FDA Medical Device Regulations as applicable to CAHW, CADI, and Collagen businesses.
• Organize existing QMS procedures per QMS documentation hierarchy and ISO 13485:2016 Clause classifications to identify gaps and redundancies, as appropriate.
• Understand existing Quality Management System processes and procedures, identify improvement/simplification opportunities, and revise quality process / procedures to improve QMS effectiveness and efficiency.
• Compare and assess QMS procedures for similar processes in CAHW, CADI, and Collagen businesses and identify opportunity to synergize/integrate associated QMS procedures with goal to create effective and unified Quality Management System for Cardiac Assist Business
• Collaborate with Corporate Quality Team to understand expectation and plan to align with GETQMS initiative.
• Revise (create, modify, combine, obsolete) Quality Manual, QMS procedures to create an effective, efficient, and lean set of Quality Management System procedures addressing CADI, CAHW, and Collagen businesses.
• Review Quality System documents and records storage and archival practices (adobe signed documents and localized archival practices) to identify potential compliance gaps and make necessary changes to ensure compliance with ISO 13485 Document Control and retention requirements.
• Communicate, interact and coordinate quality improvement efforts with Manufacturing, QA, R&D, and engineering management.
• Identify and lead implementation of new opportunities for improvements to work processes, and other areas as identified.

Required Knowledge, Skills and Abilities

• A 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 5 years with specific hand on experience in creation/sustenance of ISO13495 certified Quality Management Systems along with experience in quality assurance, quality engineering or related functions or a M.S. plus 3 years of above-mentioned experience is required.
• Prior experience working in an FDA regulated medical device organization or ISO 13485 certified organization.

• Must have demonstrated proficiency in working with ISO 13485 or 21CFR820 based M Quality Management Systems and Medical Device Regulations.
• Project management and leadership experience is required.   Previous experience supervising technicians and conducting and participating in FDA/customer/corporate audits is preferred.
• Excellent oral and technical writing skills with the ability to interface effectively and professionally across departments and at all reporting levels.
• Must demonstrate effective influencing and change management skills and demonstrated achievements in process improvements.
• Experience in 6σ Methodologies (Lean 6σ, DMAIC, DMADV) with be strong plus.
• Knowledge of Microsoft Office Products such as Word, Excel or equivalent software applications is preferred.
• Working knowledge of statistical analysis, the ability to analyze and solve complex problems, and the ability to communicate effectively across departments. Familiarity with analytical software applications is preferred.

The base salary for this position is a minumum of $100,000 and a maximum of $115,000 a year

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.