Manager Quality Compliance CS/VI (Wayne, NJ)

 

 

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 Manager, Quality Compliance is responsible for leading the Cardiac Surgery/VI Quality Compliance group. This position will have a responsibility for providing support for maintenance of quality systems, Internal audit program, CAPA process, management of 3rd party audits (FDA, ISO, other), FDA inspection response to 483 observations and periodic updates. This position partners with Quality leaders as well as representatives/leaders from the other cross functional groups on Quality Management System improvements. Develops and manages the department to assess and ensure compliance to the FDA Quality System Regulations CFR Part 820, ISO 13485 Quality System Standard, MDD, CMDR, WHLW, ANVISA, JPAL and other applicable regulations. The position will lead the quality compliance team and coordinates efforts to effectively maintain quality system to the applicable regulations and standards.

The position reports to the Wayne Getinge Headquarters upto 4 days a week.

 

Job Responsibilities and Essential Duties

• Direct the development, maintenance, and rolling review of compliance and Quality Management systems. 
• Responsible for assuring the business functions operate in compliance with applicable domestic and international requirements, laws, and guidance. 
• Provide quality review and approval, as appropriate, for change notices. 
• Assists with third party quality systems inspections and audits (i.e. FDA, ISO, corporate, etc.)
  Responsible for directing all day to day compliance activities in support of business objectives:
  • CAPA Process Management 
    • Ensure adequate follow-up through the implementation of corrective and preventive actions as appropriate.
  • Internal Audit Management 
    • Responsible for internal audit activities in accordance with 21 CFR 820.22.
  • Management Review and Monthly Metrics Meetings 
    • Manage the process for QMS monitoring, review, and follow-up activities to ensure early visibility for potential patient and compliance risks.
  • Quality Planning 
    • Manage the process for Quality Planning to ensure implementation.
  • Process Non-conformity
    • Own and manage the Process Non-Conformity activities
• Management of compliance to applicable External Standards and worldwide regulations.  Maintain compliance with 21 CFR 820, 803, 806, ISO 13485, ISO14971, and other applicable standards. 
• Write and coordinate responses to External Audits (i.e. FDA Inspection, Corporate Audits, Notified Body, etc.) 
• Manage departmental costs and spending in support of business objectives. 
• Develop and maintain a competent and accountable organization which is positioned to support and accomplish business objectives while maintaining compliance with applicable standards, laws, and guidance. 
• Ensure that all Quality Management Systems are in compliance with external and internal GMP requirements and actively provide strategic direction to support the customer needs and business targets. 
• Strengthen quality awareness, support technical services, and process improvements.
• Responsible for investigating, identifying, and implementing best in-class Quality Complian