Hybrid Senior Quality Engineer, Ops — Quality Leader

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

Job summary

Datascope Corp. is seeking a Senior Quality Engineer to lead quality engineering functions, ensuring robust quality systems and compliant processes. The role focuses on planning, CAPA, investigations, and collaboration with manufacturing, QA, R&D, and engineering teams.

The candidate will drive validations, change controls, and continuous improvements, with emphasis on cross-functional communication and effective problem solving in a fast-paced environment.

Qualifications

• Bachelor’s degree in engineering, science or equivalent is required; a Master of Science is preferred.
• A minimum of five years’ experience in quality assurance/quality engineering or MS + 3 years.
• CQE or CQA certification is desirable.
• Strong proficiency in Statistical analysis and problem solving across departments.
• Working knowledge of quality systems; familiarity with analytical software is preferred.
• Project management and leadership experience; audits experience is a plus.

Responsibilities

• Lead quality planning with documented plans and gap assessments.
• Oversee quality management activities, CAPAs, investigations, and timely closures.
• Run Material Review Board meetings and review non-conforming materials.
• Support supplier management and incoming material inspections.
• Coordinate validations, protocol development, and interdepartmental activities.
• Lead communications with manufacturing, QA, R&D and engineering management on status and issues.

Skills

Statistical analysis

Quality systems

Project management

Cross-functional communication

Microsoft Office

Education

Bachelor’s degree in engineering or science

Master of Science (preferred)

Tools

Microsoft Office

Job description

Datascope Corp. is seeking a Senior Quality Engineer to lead quality engineering functions, ensuring robust quality systems and compliant processes. The role focuses on planning, CAPA, investigations, and collaboration with manufacturing, QA, R&D, and engineering teams.

The candidate will drive validations, change controls, and continuous improvements, with emphasis on cross-functional communication and effective problem solving in a fast-paced environment.