Sr. Manager Quality and Compliance

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.

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.

Company Profile:

Talis Clinical, LLC (a Getinge AB Company) provides health technology solutions supporting clinicians on their continuous journey to improve patient outcomes. The team at Talis is committed to developing technologies that support enhanced clinical quality, while providing an intuitive, productive user experience. We are a fast-paced organization with a culture oriented toward higher purpose outcomes and principles. This will be the most meaningful work you can do.

Status: Full-Time, On Site

Job Overview

The Manager, Quality Systems for Getinge's Talis Clinical product area will be responsible for partnering with R&D, Technical Product Management, Product Testing and Customer Support and Implementation a Teams as well as other cross-functional team members to develop and implement global strategies to drive product quality and improve product release efficiencies. This manager will be a key member of the management team that supports the delivery of highly innovative Health IT products. This position will manage the Talis Quality Management System and Team including 4 direct reports focused on product testing for customer releases and all quality documentation associated with the product technical files.

Job Responsibilities and Essential Duties

• Become the Subject Matter Expert is developing client and new product testing to ensure Talis product quality metrics are met with every release and product implementation.

• Manage direct testing team of 4 while ensuring consistent release quality.
• Support ongoing development of Talis Automation projects and introduce standards for improvements in unit and regression testing.
• Manage Bug Review process and support Engineering leadership in identifying and evaluating performance improvement opportunities.

• Manage Incoming inspection processes, vendor audits and vendor certification with primary suppliers.
• Ensures the quality of technical files generated. Provides expertise and consultation on proper preparation of required documentation and files to Talis team members. Liaises with internal organizations to provide/solicit guidance and support for proper documentation and record keeping.
• Leverage a deep scientific and technical understanding of products to provide strategic guidance and support for product development, life-cycle management of products to fulfill customer requirements.
• Assures that a positive working relationship is developed and maintained with internal/external customers.
• Leads or assists internal and external regulatory (health and cybersecurity) authority / certification audits.
• Support and Manage the Talis CAPA process. Through this process continuously auditing and analyzing Talis customer experiences.
• Develop and maintain effective relationships with customers, regulatory agencies, business partners, and Talis team members by earning the reputation of consistently demonstrating transparency and honesty.
• Encourage and lead others to find ways to continuously improve, learn about new scientific, technological and qualitative methodologies, to help the Talis team improve the support of the patients and caregivers we support.

Minimum Requirements

• A bachelor's degree in engineering, Science or related field is required. A Master of Science in Engineering, Science or related field or MBA is preferred.
• A minimum of ten years experience in Software Development and Testing is required.
• People Leadership experience, including management direct reports and developing team members, is required.
• Working knowledge and experience withstandards management.
• Must have Competent Authority and Notified Body interaction experience.
• Must have in depth knowledge of global medical device and software as a medical device (SaMD)regulatory[WM1]requirements. Must have solid knowledge and experience in matters relating to organizational skills and personnel management.
• Must demonstrate effective written and verbal communication skills, including technical writing skills.
• Must have demonstrated ability to mentor, develop and influence team members.
• Must be able to travel up to 20%
• Position is full time on premise at Streetsboro Ohio location

Desired Attributes

• Proven problem solver
• Conceptual learner
• Reliance on influence to lead
• Focus on earning Customer Loyalty by turning negative experiences into positive experiences.
• Visionary leader that can provide a vision they are committed to with the passion to stay the course.

Other Requirements

• Able to lift up to 25 pounds
• International Travel Visa

Education:

• A bachelor's degree in engineering, Science or related field is required. A Master of Science in Engineering, Science or related field or MBA is preferred.

The base salary for the position is a minimum of $157,000 and maximum salary of $196,000 plus annual bonus of 25%

#LI-YA2 #LI-Onsite

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. 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.

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.

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.