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VP, Quality Operations ACT

1 month ago

Detroit, Michigan, United States Getinge Full time

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.

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 1.5°C 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 Vice President, Quality Operations ACT within our global Acute Care Therapy (ACT) business area. The ACT business area is the largest of 3 Getinge business areas with responsibility for designing and manufacturing lifesaving medical products for use in cardiovascular surgery, critical care, and intensive care. The ACT business area is geographically distributed with manufacturing sites in the U.S., Germany, France, Sweden, Turkey, and China. This key leadership role will ensure continued quality operations and progressing on the compliance journey. The Vice President is responsible for leading the development and improvement of the Quality Operations capabilities, and enhancing and supporting the continuous improvement of product and quality system performance, globally.

This position may be based at any Getinge location. Remote locations may be considered for the right candidate if based in a time zone that can virtually support the business locations.

Job Responsibilities:

Site locations- US, France, Germany, Sweden, Turkey

  • Lead quality operations for the Acute Care Therapy division, ensuring compliance with worldwide regulatory standards and internal policies.
  • Oversee the execution of internal and external audits, ensuring compliance with ISO standards, FDA regulations, and other relevant requirements.
  • Establish and lead a robust CAPA governance board that addresses compliance gaps and meet the requirements of the consent decree.
  • Collaborate with cross-functional teams, including R&D, manufacturing, supply chain, and regulatory affairs, to ensure quality is integrated throughout the product lifecycle and compliance gaps are closed.
  • Lead and mentor a team of quality professionals, fostering a culture of quality excellence and professional development.
  • Ensure timely and effective resolution of quality issues, including non-conformances, customer complaints, and audit findings, with a focus on addressing consent decree requirements.
  • Develop and monitor key performance indicators (KPIs) to measure the effectiveness of quality operations and drive improvements, specifically targeting compliance issues.
  • Lead the cross-functional Risk Management Board. Enable robust decision making for Field actions, Health Hazards, risk management activities, including Failure Mode and Effects Analysis (FMEA) and root cause analysis.
  • Lead budget and organizational structure development and management including planning for future needs and skill sets.
  • Stay abreast of industry trends, regulatory changes, and best practices to continuously enhance the quality operations function and ensure ongoing compliance.
  • Benchmarks internal and external organizations, identifies, implements, leverages, and transfers best practices knowledge to ACT.
  • Partner with Corporate Quality on GetQMS, procedures, and tools
  • Strengthen the quality audit network to drive proactive remediation.
  • Drive compliance and improvement in internal and external audit metrics

Qualifications:

  • Undergraduate degree in a Science or Engineering discipline, or equivalent is required.
  • Minimum of 15 years medical device regulatory experience is required. Prior experience with both capital equipment (hardware, software) and disposable medical devices is preferred.
  • Experience in supporting organization through US FDA, EU MDD/MDR, and MDSAP inspections.
  • Experience writing, reviewing, and providing feedback on audit responses.
  • Knowledge of and experience in all quality operations aspects of the business
  • Prior experience operating and leading within a business under consent decree or warning letter.
  • Demonstrated comprehensive expertise in the applied interpretation of the US, EU, and Worldwide regulatory standards and laws applicable to the medical device industry, e.g., ISO, QSR, GMP, GLP, GCP, MDR, IVDR, MDSAP
  • Strong interpersonal and team dynamic skills in working with organizations to address issues and execute plans, with the ability to lead and influence without direct authority.
  • Excellent verbal and written communication skills
  • Strong negotiation and facilitation skills
  • Understands impact on patient and customer, generates ideas, and embraces change.
  • Demonstrated ability to work under tight deadlines and handle multiple/detail-oriented tasks.

The Vice President, Quality Operations ACT reports to the SVP, ACT Quality & Regulatory.

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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.