Sr. Director, Quality Assurance( (Wayne, NJ)

Davita Inc.; Wayne (NJ); Remote; USD 231,000 - 347,000; Full time

Job summary

A leading company in life-saving technology is seeking a Senior Director for Quality & Regulatory Compliance in Wayne, NJ. In this pivotal role, you will oversee quality assurance programs and ensure compliance across multiple production sites. You will guide a competent team, manage audits, and drive process improvements while maintaining regulatory standards. Ideal candidates will hold a Master’s degree in Engineering or Life Science with extensive experience in quality assurance within medical device environments.

Qualifications

• Requires 15 years of Quality Assurance experience.
• Proven leadership in advanced quality system strategy development.
• Experience in medical device manufacturing and compliance.

Responsibilities

• Plan, direct, and coordinate quality assurance programs.
• Lead audits, manage nonconformance, and prioritize quality activities.
• Ensure compliance with standards and regulations.

Skills

Leadership

Quality Assurance

Regulatory Compliance

Risk Management

Quality Engineering

Education

Master's degree in Engineering or Life Science

Tools

MS Office

Job description

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 title: Senior Director Quality & Regulatory Compliance

Job Location: 45 Barbour Pond Dr, Wayne, NJ 07470

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.

Requirements: Requires a Master's degree in Engineering, Life Science, or a related field plus 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.

Position will supervise employee(s). Employer will allow remote/telecommuting throughout the U.S. 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.

Salary $231,120 - $346,680 / annual. Standard employe benefits.

To Apply: https://careers.getinge.com/job-invite/35118/

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.