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 Compliance practices Cardiac Surgery Quality Compliance group.
• Establish credibility and confidence with key internal and external colleagues through regular communication and proven performance.
• Works collaboratively with internal functional departments (Quality Assurance, R&D, Purchasing, Sourcing, and Operations, other) to accomplish business objectives while maintaining compliance with applicable standards, laws and guidance.
• Ensure that the conformity of the devices is appropriately checked, in accordance with the Quality Management System under which the devices are manufactured, before a device is released.(To comply with Article 15 of European Union Medical Device Regulation (EU MDR) (Regulation (EU) 2017/745 of the European Parliament and of the council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC).

Minimum Requirements

• A Bachelor’s Degree in Engineering, Science, or other related field (or related work experience) is required.  A Master’s of Science (or related field) or MBA is a plus. ASQ, CQE, greenbelt or other applicable certifications are a plus.
• A minimum of ten years of experience in quality assurance, quality compliance, or related functions in a FDA regulated industry or ISO certified organization is required.
• A minimum of ten years related experience managing quality systems and implementing Quality Management systems in the medical device or pharmaceutical or related industry is preferred.

• Must have demonstrated presentation aptitude, facilitation skills, and the ability to interact and effectively communicate with senior management and manufacturing staff at all levels.
• Must be able to lead others in the use of critical thinking, problem solving, and analysis.
• Must have effective leadership, problem solving, decision making, influencing, and negotiation skills.
• Must have the ability to assess the impact of quality management strategies on business performance.
• Must have in depth knowledge of all applicable Quality and Regulatory standards.
• Certified Quality Compliance Auditor

The base salary for the position is a minimum of $124,000 and a maximum of $150,000 plus 15 % annual bonus

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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.