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Senior Quality Engineer (Wayne, NJ) Defined Term

Senior Quality Engineer (Wayne, NJ) Defined Term

GetingeWayne, NJ, US
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Senior Quality Engineer (Wayne, NJ) Defined Term

Date : May 24, 2025

Location : Wayne, NJ, US

Company : Datascope Corp.

Remote Work : 1-2 days at home (site based)

Salary Range : Defined Term 1 year - $100,000 and a maximum of $115,000

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, and preparation / revision of QMS Procedures to ensure compliance.

This position is a Defined Term position for one year, located in Wayne, NJ, with 4 days onsite per week.

Job Responsibilities and Essential Duties

  • Review Quality Manual to identify potential gaps in documented quality processes, procedures, and outsourced processes to ensure compliance with ISO 13485 : 2016, MDSAP, and FDA Medical Device Regulations applicable to CAHW, CADI, and Collagen businesses.
  • Organize existing QMS procedures per documentation hierarchy and ISO 13485 : 2016 classifications to identify gaps and redundancies.
  • Understand current Quality Management System processes, identify improvement opportunities, and revise procedures to improve effectiveness and efficiency.
  • Compare and assess QMS procedures across different business units and identify opportunities to unify and streamline the Quality Management System for the Cardiac Assist Business.
  • Collaborate with Corporate Quality Team to align with GETQMS initiatives.
  • Revise or create Quality Manual and QMS procedures to address multiple business units effectively.
  • Review document storage and archival practices for compliance with ISO 13485 requirements and implement necessary changes.
  • Communicate and coordinate quality improvement efforts across manufacturing, QA, R&D, and engineering teams.
  • Identify and lead implementation of improvements to work processes and other areas as needed.

Required Knowledge, Skills, and Abilities

  • Bachelor's degree in engineering, science, or equivalent; Master's preferred. CQE or CQA certification desired.
  • Minimum 5 years of experience in ISO 13485 certified Quality Management Systems, with experience in quality assurance, engineering, or related fields; 3 additional years if holding a Master's degree.
  • Experience working in an FDA-regulated medical device organization or ISO 13485 certified organization.
  • Proficiency in working with ISO 13485 or 21 CFR 820 regulations.
  • Project management and leadership experience, including supervising technicians and participating in audits.
  • Excellent communication skills, both oral and written.
  • Effective influencing and change management skills, with a record of process improvements.
  • Knowledge of Lean Six Sigma methodologies is a plus.
  • Proficiency with Microsoft Office applications and statistical analysis tools.

    • The salary range for this position is from $100,000 to $115,000 annually.

    About us

    Getinge is committed to providing access to quality care through innovative products and solutions for healthcare and life sciences. Employing over 12,000 people worldwide, our products are sold in more than 135 countries.

    We are an equal opportunity employer, and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, veteran status, or any other protected characteristic. Reasonable accommodations are available upon request during the application process.

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    Senior Quality Engineer • Wayne, NJ, US