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Dir Continuous Improvement ACT QA & RA

Getinge | Wayne, NJ, US, 07470

Salary Range:$94,000 – $139,000 Salary range estimated by Zippia

Posted 38 minutes ago


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Description

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.

Getinge is a global company that designs and manufactures medical devices and life science equipment. We impact the environment in various ways during a products life cycle so we have a goal to be CO2 neutral by 2025 and we are also engaged in achieving the Paris Agreement goal of limiting global warming to 1.5C above pre-industrial levels.

We are focused on the pride and passion we have in belonging to Getinge and how our employees can share a passion to be part of a company with the central purpose of saving lives. We are looking for individuals who share this passion to join our team.

We currently have an opening for a Director, Continuous Improvement, Quality & Regulatory within our global Acute Care Therapy business area. The role will have responsibility for providing leadership and support for the Continuous Improvement program and role is key in establishing programs across the different Product Areas and manufacturing sites to drive quality and regulatory improvements. Other responsibilities include leading and tracking of the Quality & Regulatory Continuous Improvement program, increasing level of problem-solving capabilities, driving horizontal deployment of best practices, and ensuring alignment with best practices and strategies across Getinge.

Job Responsibilities:

  • Provide strategic and project leadership for the ACT Quality & Regulatory organization through pro-active, clear, and robust communication of requirements, risks, and milestones. This role will be accountable for all deliverables and objectives for the ACT Quality & Regulatory organization and will drive implementation and execution of the strategy.
  • Lead, grow, mentor, and coach to develop a strong a continuous improvement mindset to support the business today and in the future.
  • Drive efficiencies, lessons learned, and solutions across the ACT product areas.
  • Collaborate with other Continuous Improvement leaders across Getinge to drive and grow a pro-active, efficient, and effective outcomes that support the deployment of Continuous Improvement tools.
  • Benchmarks internal and external organizations, identifies, implements, leverages, and transfers best practices knowledge to ACT.
  • Establishes tracking mechanisms that record measurable results of Continuous Improvement in terms of process efficiency, customer satisfaction, financial, and non-financial.
  • Develops and maintains an overall dashboard to track Continuous Improvement program project progress and develops other communication mechanisms to demonstrate and track value of Quality & Regulatory Continuous Improvement efforts.

Qualifications:

  • Undergraduate degree in Engineering or equivalent is required.
  • Green Belt in Six Sigma or transactional process improvement or equivalent in ASQ Certification & Experience is desired. Knowledge in evolving Six Sigma concepts and tools.
  • Minimum of 10 years medical device regulatory experience is required. Prior experience with both capital equipment (hardware, software) and disposable medical devices is preferred.
  • Expertise in developing and executing successful regulatory strategies for U.S. Class II devices and EU Class III devices is required.
  • Ability to manage complex matrixed organizational structures and demonstrated capability in collaborating and influencing across such an organization is required.
  • Proven track record as a change leader.
  • Strong interpersonal skills including communications, facilitation, consulting, coaching, and influencing.
  • Demonstrated ability to work under tight deadlines and handle multiple/detail-oriented tasks.
  • Working knowledge of cGMPs and ISO requirements

About us

Getinge is on an excitingtransformation journey constantly looking for new ways to innovate together with our customersto meet the healthcare challenges of the future. We are committed to diversity, equity and inclusion and to sustainability with a goal to beCO2 neutral by believe in giving our employees the flexibility they need and make every effort to foster a learning culture that supportstheirpersonal development passionatepeople hold our brand promise 'Passion for Life' close to heart.

Ifyoushareourpassionandbelievethatsavinglivesisthegreatestjobinthe world,thenwelook forwardtoreceivingyourapplication and resume. We hope you will join us on our journey to become the world's most respected and trusted Medtech company.

Benefits at Getinge:

At Getinge, we offer a comprehensive benefits package, which includes:

  • Health, Dental, Vision and Travel insurance benefits
  • Registered Pension Plan with company match
  • Paid Time Off
  • Wellness initiative & Health Assistance Resources
  • Life Insurance
  • Short and Long Term Disability Benefits
  • Hybrid Work Arrangements (where applicable)
  • Parental and Caregiver Leave
  • Tuition Reimbursement

Getinge is an equal opportunity employer. Getinge will, at all times, will comply with all applicable human rights and other legislation when considering all qualified applicants for employment. Accommodations are available upon request for candidates taking part in all aspects of the selection process.

$210k - $220k/30% bonus

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