What if the work you did every day could impact the lives of people you know? Or all of humanity?At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.
This role will provide business partner support to the regional Service and Support (S&S) teams, you are the contact person for quality and compliance activities that affect our ability to support our customers. You are working in close collaboration with our QMS & Compliance/Regulatory teams as well as your colleagues from the field/internal support teams to promote continuous quality and process improvement. You are monitoring & reviewing cases related to installation, service activities and complaints to support and ensure record compliance of the S&S teams. Responsibilities involved (but not restricted to) follow up with record owners for correction/update; promoting best practices and education around good records keeping.
Tasks and Responsibilities:
- Lead Field Compliance Reviews for the Service & Support teams and communicate any compliance risks noted from these activities to Service & Support Management
- Lead key compliance metrics monitoring for the S&S teams and part of the QMS (potential Adverse Event, case compliance)
- Work with QMS and compliance team to continuously educate the AMEA Service and Support team on importance of QMS and facilitate implementation of best practices.
- Collaborate with Global Compliance team and regional counterparts on process improvement and routine audits.
- Provide support and backup to the Service Ops Analyst and Service Delivery Program Manager as needed.
- Identify and prioritize process and system enhancement opportunities
- Participate in projects relating to process and system improvement and drive execution of key projects
- Report on service and support performance and KPIs
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.
Requirement
- Meets deadline, effective use of time and handle multiple assignments simultaneously
- Exceptional interpersonal and collaboration skills
- Excellent written and verbal communication skills
- Understanding of service and field activities
- Detail oriented
- Ability to work alone as well as part of a team
Experience/education
- Minimum of bachelor’s degree or advanced degree (Master's) in applicable field or equivalent preferred.
- Experience in quality system and clinical market is preferred
- Compliance, Service Operations, or Field Service Experience preferred
- Basic technical/engineering background
- Working knowledge of ISO13485 and Quality System regulations
- Knowledge of SalesForce.com
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Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.
