Senior Director Quality & Regulatory Compliance Position Available In Passaic, New Jersey

Company Name:

Datascope Corp.

Job Location:

45 Barbour Pond Drive, Wayne, NJ 07470. Employer will allow remote/telecommuting throughout the U.S.

Job title:

Senior Director Quality & Regulatory ComplianceMinimum Salary:

$231,120 – $346,680 per year

Education:

Master’s degree in Engineering, Life Science, or a related field.

SOC Code:

11-3051.01

SOC Occupation Title:

Quality Control Systems ManagersDuration:

Regular Hire Work week:

Full-timeSupervision Required:

Yes – position will supervise employee(s)

Travel Required:

International travel twice a year to company sites in Sweden, Germany, Turkey, France, Spain, or China. Each trip lasting 5 business days. Possible domestic trips to company sites in Merrimack NH, Denver CO, Alanta GA, Columbus OH, Miami FL, Fraser MI, Phoenix AZ, or Des Moines IA.

Experience:

15 years of Quality Assurance experience. Requires skills and experience in the following: 5 years of senior-level experience (Director or above). Proven leadership in advanced quality system strategy development. Experience in engineering disciplines, including Production and Design Quality Engineering, CAPA, and Non-Conformance management. Experience in a medical device manufacturing environment. Familiarity with

ISO 13485

certified and FDA QSR compliant Quality Systems. In-depth knowledge of FDA and EU regulatory compliance for medical devices. Strong understanding of Quality System Regulation (QSR) and Quality System Inspection Technique (QSIT) audits. Proficient in MS Office applications (Word, Excel). Expertise in the Sterile Class III and Electromechanical medical devices and familiarity with the product line in operations and manufacturing environments.

Job duties: Plan, direct, and coordinate quality assurance programs. Formulate quality control policies and control quality of laboratory and production efforts. Lead the Quality and Compliance teams at the New Jersey sites (Wayne, Mahwah, and Fairfield) supporting Cardiac Assist (CAHW & CADI). Responsible for overseeing all Quality functions at these sites, including managing teams at locations under Consent Decree/warning letters. As a member of the leadership team, this role provides strategic direction for Quality Systems across New Jersey, ensuring compliance with applicable standards and regulations. Key responsibilities include developing and managing a competent Quality organization, ensuring the Quality Management System is defined, implemented, and maintained, and reporting on system performance to top management. The role also includes leading audits, managing nonconformance products, and prioritizing Quality Engineering and Control activities. Provide technical expertise in risk management, design controls, and production controls. Responsible for regulatory compliance, managing third-party inspections and audits, and overseeing audit responses. Work closely with cross-functional teams to meet quality metrics, support process improvements, and manage departmental costs. Lead the quality leadership team, mentoring staff, and ensuring compliance with external and internal standards.

Apply @ https://careers.getinge.com