Senior Manager Quality Logistics (East Windsor, NJ)

Getinge • East Windsor, NJ

149d • $173,000 - $200,000 • Remote

About The Position

The Senior Manager Quality, Logistics is responsible for leading the Quality and Compliance to international, federal and state regulations for all products managed at the North American Logistics Center. This includes products manufactured at 22 Getinge global facilities, spare parts, accessories and disposables that are distributed globally from the site. The Sr Manager is also responsible for Quality oversite of the for the Reverse Logistics activities including customer returns, product from customer complaints and field actions. The position will be part of the site leadership team and will be responsible for establishing, administering and maintaining the Logistics Quality Management System that meets all FDA and ISO13485 requirements. This position will lead a team of Quality Specialists at the site and work closely with site Operations and Planning to assure Getinge customer needs and expectations are consistently met.

Requirements

• Bachelor's degree in engineering or Life Science related field or equivalent.
• A minimum of 10 years hands-on experience in Quality Assurance within an FDA regulated company.
• Progressive leadership experience including hands on advanced quality system strategy.
• Excellent knowledge of FDA and EU regulatory compliance for medical devices.
• Knowledge of Technique Audits (QSIT) and experience as an ISO13485 internal auditor.
• Demonstrated knowledge of Quality System Regulation (QSR) and Quality System Inspection.
• Strong influencing skills and the ability to build strong interpersonal relationships.
• Excellent communication skills including public speaking and strong written skills.
• Demonstrated leadership within a cross-functional environment.
• Advanced skills in MS Office applications (Word/Excel) are required.
• Bilingual in Spanish and English.

Responsibilities

• Provide strategic and tactical leadership of Quality at the Global Logistics Operations at the East Windsor, NJ Distribution Center.
• Develop and implement an effective and compliant Quality Management System including the development of electronic processes and record management.
• Develop a competent and accountable Quality organization that is positioned to support and accomplish business objectives while maintaining compliance with applicable standards, laws and guidance.
• Ensure that the quality management system is effectively defined, documented, implemented, and maintained.
• Report to top management on the performance of the quality management system.
• Act on behalf of senior management during audits (internal and external).
• Place products or processes on hold.
• Manage quality audit functions.
• Contribute to corrective and preventive action activities, handling of nonconformance product.
• Perform the role of North American Distribution Management Representative.
• Perform the role of Board of Pharmacy Designated Representative for all US states.
• Oversee third party quality systems inspections and audits, (i.e. FDA, ISO13485, corporate, etc.).
• Lead preparation of third-party audit responses.
• Work with cross functional teams to establish quality metrics that align to the corporate goals and develop and implement Quality Plans to assure the goals are met.
• Develop a Quality program which drives personal accountability for accuracy, consistency, and completeness for Logistics.
• Partner with Global Logistics and Quality teams to effectively create and support process and quality enhancement initiatives to create and maintain an environment of excellence and continuous improvement across all Getinge Logistics sites, globally.
• Develop and implement a bilingual training program to assure production employees job competence.

Benefits

• Base salary of $173,000 to $200,000 plus 25% annual bonus.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Wholesale Trade Agents and Brokers
• Education Level: Bachelor's degree