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Vice President, Quality

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 & Regulatory Compliance & Quality Systems 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. The role is key in leading regulatory compliance communications to ensure compliance of the Product Area Quality Systems with applicable regulatory requirements and with the business strategy. The Vice President is responsible for leading the development and improvement of the Quality & Regulatory Compliance 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:

  • In collaboration with the ACT QRC Management Team, provide a comprehensive evaluation of the compliance profile of all ACT sites.
  • Provides expert analysis and counsel on domestic and international compliance matters involving the design, development, manufacture, and distribution of ACT's medical device portfolio.
  • Support the development and review of external Health Authority and notified body observation responses (appropriate response, investigation, corrective actions, timing, execution) complaints, and appeals.
  • Maintains comprehensive knowledge of applicable regulatory requirements and their interpretation inclusive of monitoring and sharing of external Quality & Regulatory compliance insights across ACT.
  • Provides leadership and guidance in timely communication / escalation of issues associated with quality systems & compliance risk.
  • The position is also responsible for partnering with Regulatory in managing a closed-loop process of reviewing critical regulatory submissions (e.g. 510(k), EUTechnical Files).
  • Establishes global auditor qualifications and competency requirements to ensure a consistent level of auditor competency across ACT and continuously improve the skills and capabilities of auditors as it relates to internal requirements and external regulations.
  • Partners with stakeholders to develop strategies and tools to ensure External Audit readiness across ACT, providing strategic support where needed.
  • Benchmarks internal and external organizations, identifies, implements, leverages, and transfers best practices knowledge to ACT.
  • Liaise and 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 regulatory compliance aspects of the business: pre-market, commercial, post-market, and regulatory
  • Prior experience operating and leading within a business under consent decree or warning letter.
  • Demonstrated comprehensive expertise in the applied interpretation of the US 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, ACT Quality & Regulatory Compliance & Quality Systems 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.