[Hiring] Program Manager, Quality and Compliance @Getinge

Role Description

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.

• 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.

Qualifications

• 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.

Requirements

• Mastery of SAP.
• General understanding of product data structures and hierarchy models.
• 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.

Benefits

• 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.