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Ascensia Diabetes Care Senior Manager of Quality and Post Market Surveillance in Kalamazoo, Michigan

Ascensia Diabetes Care is a global specialist diabetes care company, dedicated to helping people living with diabetes. Our mission is to empower people living with diabetes through innovative solutions that simplify and improve their lives. We use our innovation and specialist expertise in diabetes to develop high quality solutions and tools that make a positive, daily difference for people with diabetes.

E s s en t ial Job Functi o n s and A c c oun t abilit i e s :

  • Manage and continually improve all elements of the Quality Management System (QMS/ISO 13485) including the following processes:

  • Root Cause Analysis

  • Corrective and Preventive Action

  • Document Control

  • Change Management

  • Supplier Management

  • Acceptance Activities including Incoming Inspection, In process, and Finished Product inspections, Device History Records, Non-Conforming Records, and the Quality Hold process

  • Internal Audits

  • Complaints / Post Market Surveillance

  • Work collaboratively with the field/technical service team and the global complaint team to effectively manage the complaint intake process and the overall complaint management system within Veeva

  • Lead problem solving activities and implementation of permanent solutions

  • Establish and monitor performance metrics, champion quality and customer focused initiatives.

  • Drive reduction of customer complaints using solid investigation methodologies and root cause analysis expertise.

  • Utilize in-house and externally obtained data to drive product improvements and reliability

  • Track and monitor key performance indicators and create summary reports for the site.

  • Utilizing key process indicators (KPI’s), promote and initiate continuous improvement activities that drive change within the business that result in cost effectiveness, revenue enablement and support overall Epredia objectives.

  • Act as Quality Management Representative for the Kalamazoo site.

  • Develop the team and build a cross functional team collaborative culture

  • Coordinate QA improvement activities with product management, software & product development, test and operational support teams.

  • Lead and support supplier quality improvement activities for the site. This includes alignment and support of the global supplier quality systems and processes.

  • Support sourcing initiatives assisting with vendor management and selection.

    Q ual i f ic a t io n s /S k il l s:

  • Bachelor’s degree

  • Proven Quality management experience in a manufacturing environment within the medical device industry of at least 10 years

  • Problem solving and root cause analysis expertise

  • Experience with budgets and cost tracking

  • Quality Systems Regulations experience, knowledge of ISO13485

  • Displays Role Model Leadership Skills

  • Supervisor/Management experience required, developing people and self

  • Effective and open communication and attention to detail

  • Must demonstrate strong organizational skills

  • Strong team player and leader with the ability to work with other functional leaders and build strong relationships

  • Multi-site experience is a plus

  • Working knowledge of international medical device regulation.

  • Ability to handle critical timelines in a multi-task environment

  • Proficient in MS applications (Excel, Word, Outlook)

  • ISO13485 Lead Auditor Certification preferred

  • Demonstrated experience as Six Sigma Black Belt or with other continual improvement methodologies is preferred

  • Must be available to travel up to 20% of the time

#LI-LVI

YOUR APPLICATION:

Ascensia offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and are driven by innovation and the desire to improve the lives of our patients, we encourage you to apply now. Job postings will remain open for a minimum of five business days and are subject to immediate closure thereafter without additional notice.

TO ALL RECRUITMENT AGENCIES:

Ascensia does not accept unsolicited third party resumes.

Ascensia is an Equal Opportunity Employer including Disability/Protected Veterans (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm) .

If you are interested in applying for employment with Ascensia and need special assistance or an accommodation to use our website, please contact us at ApplicantAccommodations@ascensia.com

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