Program Manager, Quality and Compliance - Remote US

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 Product Data Program Manager will serve as the subject matter expert for product data supporting the global product ship hold and field action processes for Getinge within the Global Services organization.

Job Responsibilities and Essential Duties

• Collaborate effectively with all entities (businesses) across Getinge and serve as subject matter expert for the Getinge global product ship hold process.
• Extract, analyze, and validate product data from Getinge ERP system (SAP) to support field actions, investigations, audits and other quality activities.
• Lead and/or participate on cross functional project teams to identify and implement solutions for identified issues related to product data and associated topics.
• Collaborate with internal teams, including regulatory, quality, manufacturing, and customer service, to gather data and ensure accurate product data flow and documentation through all aspects of the field action process .
• Provide input for and/or review departmental procedures, work instructions, templates, and guidance related to product data.
• Provide support for internal and external audits.
• Stay current on changes in SAP functionality and best practices related to field actions and product data, incorporating these into the company's processes and procedures.
• Other responsibilities as assigned.

Minimum Requirements

• A Bachelor's degree in a scientific, technical, or information based discipline or equivalent work experience.
• A minimum of 6 years of experience in a technical, operations or data focused role using SAP as a core system. Experience in medical device or pharmaceutical industry preferred.
• Three or more years prior experience with field actions and/or product holds is preferred.

Required Knowledge, Skills and Abilities

• Mastery of SAP
• Must have general understanding of product data structures and hierarchy models
• Must have general understanding of reporting tools
• Strong analytical and problem solving skills with demonstrated ability to analyze complex data sets, identify trends and present actionable findings
• Program Management experience in Quality function.
• Advanced knowledge of Quality Management System operations and application of Regulations, ISO standards, and management controls.
• Experience with post-market quality activities - recalls/field actions, CAPA, complaint handling, corrections and removals.
• Proficiency with Microsoft Office Suite - MS Word, Excel, PowerPoint, Outlook, and Teams.
• Exceptional verbal, written, and presentation skills.
• Excellent time management skills, ability to work independently, self-motivated, and highly accountable for deliverables and timelines.
• Detail-oriented, highly organized, and performs work with a high degree of accuracy.
• Effective problem-solving capabilities, solution-oriented with the ability to understand, review, and communicate complex technical concepts concisely and accurately.

Salary range: $160k - $180k

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.

Benefits at Getinge:

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

• Health, Dental, and Vision insurance benefits
• 401k plan with company match
• Paid Time Off
• Wellness initiative & Health Assistance Resources
• Life Insurance
• Short and Long Term Disability Benefits
• Health and Dependent Care Flexible Spending Accounts
• Commuter Benefits
• Parental and Caregiver Leave
• Tuition Reimbursement

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.