Director, Infection Control Consumables

At Getinge we have the passion to perform

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge, our passion is to secure that every person and community have access to the best possible care, offering hospitals and life science institutions products and solutions that aim to improve clinical results and optimize workflows. Every day we collaborate to make a true difference for our customers – and to save more lives.

Are you looking for an inspiring career? You just found it.

At Getinge, we exist to make life-saving technology accessible for more people. To meet future expectations and perform at our best, we need Team players, Forward thinkers and Game changers. Getinge offers a generous benefit package (including access to health insurance, time off accruals and 401k participation - day of hire), a robust PTO program and fully supports the "work/life balance" philosophy.

Job Function Summary:
The purpose of this position is to oversee, drive and support the product segment “Infection Control (IC) Consumables” within the Business Area Surgical Workflows (SW) in its operation and to liaise with the SW Central Quality & Regulatory Compliance (QRC) Function as well as with the Global Quality Compliance, Regulatory and Medical Affairs (QcRM) function so that the Global QMS Directives/Procedures and applicable standards and regulations are implemented and followed. In addition, the position will be responsible for the Post Market Integration to ensure the best possible QMS setup within the SW product segment of IC Consumables. 

Special Features/Conditions:
The position will be remote and is preferred to be based in the Michagan area. It will support Getinge Operations in Michigan, Colorado, Florida and France.

The role requires domestic and international travel. Travel anticipated to average 20% annually but may vary depending on project needs.

Job Functions:
•    Liaise with people at all levels in the organization in a proactive manner
•    Develop and implement the SW QRC strategy in this product segment, aligning with organizational goals.
•    Oversee the product lifecycle, ensuring products meet quality standards, regulatory requirements, and customer expectations
•    Collaborate with cross-functional teams to drive product development and launch activities
•    Establish a structure and quality culture which help Getinge to meet all applicable regulations and standards, such as but not limited to FDA QSR, EU MDR 2017/745, ISO 13485, and ISO 9001
•    Be a proactive and collaborative member of the SW QRC Management Team 
•    Provide updates on QRC related issues and achievements and identify new requirements and customer needs to align the SW QRC agenda and strategy
•    Collaborate with business leaders in the Business Area SW and Global QcRM to assess processes, services and solutions and identify process improvements
•    Support colleagues by following up on designated metrics and plans related to QRC strategies, policies, procedures, compliance, complaints, licenses, training, and audits
•    Secure a high performing team by recruiting, developing, coaching, and leading people
•    Provide direction and feedback to individuals and team to support organizational developmental efforts necessary to execute the strategy
•    Foster a culture of innovation, collaboration, and continuous improvement

Required Knowledge, Skills and Abilities:
•    Broad knowledge of Quality Management Systems (ISO 13485 and ISO 9001)
•    Knowledge in regulations, such as FDA 21CFR820 and EU MDR 2017/245
•    Good understanding and experience of Global Regulatory Agencies (competent authorities and notified bodies) requirements and practices
•    Knowledge of the product lifecycle (i.e., product development and design change process)
•    Good analytical and problem-solving skills  
•    High level of attention to detail and accuracy 
•    Demonstrated ability to interact effectively at all levels of an organization on QRC related issues and practices
•    Ability to work and lead in a matrix organization
•    Demonstrated consultative skills
•    Intermediate to advanced skills in Microsoft Office package (e.g., Microsoft Word, Excel, PowerPoint) other relevant office IT tools.

Experience and Education Requirements:
•    Minimum Bachelor´s Degree in Science, quality, or related discipline; advanced degree preferred
•    A minimum of 5+ years related Quality and Regulatory Management experience in an FDA regulated environment (medical device experience highly preferred)
•    Proven experience in a Quality leadership role and goal-oriented management style with capability to manage in a matrix organization with international business partners
•    Experience with risk management, usability, corrective action, and complaints
•    Experience in driving a “Quality Culture” in the work environment

Permissions:
Permissions/Authorities according to Getinge Quality System

Supervision/Management of Others:
Responsible for the development and management of direct reports

Internal and External Contacts/Relationships:
•    Managing Directors of the respective IC Consumables product segment, SW QRC Management team, Global QRC, SW Operations, SW Finance and SW Research & Development.
•    Internal and external stakeholders (authorities, notified bodies, customers)

Disclaimer: 
The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.

The salary range for this position is a minimum of $171,000 and a maximum of $214,000 plus a 30% annual bonus

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About us 

Getinge is on an exciting transformation journey constantly looking for new ways to innovate together with our customers to meet the healthcare challenges of the future. We are committed to diversity, equity and inclusion and to sustainability with a goal to be CO2 neutral by 2025. We believe in giving our employees the flexibility they need and make every effort to foster a learning culture that supports their personal development and creativity. Our passionate people hold our brand promise ‘Passion for Life’ close to heart. 

If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application and resume. We hope you will join us on our journey to become the world’s most respected and trusted medtech company.