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Senior Complaint Systems Data Manager

Req ID:  1369

Working Location: CALIFORNIA, SAN JOSE; MASSACHUSETTS, SOUTHBOROUGH; PENNSYLVANIA, CENTER VALLEY 

 

Are you looking for a company that cares about people’s lives and health, including yours? At Olympus, we help make people’s lives healthier, safer and more fulfilling, every day. 
 
Let’s inspire healthier lives, together.

Job Description

This position is responsible for leading and directing the complaint handling process projects and quality and data monitoring program within Market Quality. The Manager, Complaint Process/ Data has responsibility for the complaint handling relationships processes and system relationships, as well as the management administration of the quality and data monitoring program and organizing complaint handling activities through project management.  

Job Duties

* Act as a project/program manager for Market Quality Projects and represent Market Quality complaints as functional area representative on projects outside of the department impacting Market Quality complaints.

 

* Manage Market Quality complaint handling projects: strategy execution, and communication to internal and external customers, business partners, regulators, and  senior executive management.
 

* Serve as the liaison between complaint handling sources and Market Quality Complaints eliminating, preventing silos and gaps in the process workstreams and hand-off.

 

* Communicates effectively across complaint handling source systems to understand implementation, system release, maintenance or any system downtime impacting Market Quality is well understood and planned for.
 

* Create and maintain Market Quality blueprint document(s) of how complaints pass through source systems and manual sources to Market Quality work streams.
 

* Chair and manager the change control board for complaint system/process changes.
 

* Analyze and determine failure point of complaint processing through source systems to complaint handling and determine root cause.

 

* Oversees Root Cause Analysis on identified gaps and findings on the complaint processing.

 

* Manages and executes to completion remediation activities, including CAPAs and audits, necessary to improve compliance, ensuring that all stakeholders implement activities.   
 


* Works with OCI, LAD and OUS departments to ensure that all organizations are executing complaint processing consistent with company goals, objectives and KPIs.  

 

* Where action is required to achieve objectives, identifies the solutions within a cross functional team and drives projects through to completion.
 

* Provides guidance to all departments on KPI achievement, facilitating discussions to enable measurement, management, and reporting.  

 

* Works with department leaders to identify meaningful metrics to improve processes and care.  

 

* Develops systems to collect, measure, and report performance improvement results.

 

* Participates in system-wide data analytics initiatives.
 

* Serve as Market Quality representative for software tools and technology enhancements to ensure process is well understood, mitigate unfavourable impact to Market Quality complaint handling inputs and process.
 

* Participate in Complaint Handling systems designs, enhancements, updates (quality system, business perspective) including writing business functional requirements and performance qualification testing scripts.
 

* Manage quality assurance testing on all pre- and post-application implementations, system releases involving Complaint Handling.
 

Job Requirements

REQUIRED QUALIFICATIONS:

 

* Bachelor’s degree is required.

 

* Minimum of 5years management level experience in a drug/device manufacturer/ distributor [environment], with strong concentration in QSR compliance and quality assurance.


* Travel as required, including international travel.

 

PREFERRED QUALIFICATIONS:

 

* Demonstrated experience in complaint data analytics and leading cross functional remediation projects is required.

 

* Proficient understanding of medical device regulations which include complaint handling and medical device reporting.  

 

* Strong analytical, organizational and communication skills.
 


 

We realize work isn’t just a job to you.

It’s a big part of your life, but not the only part. That’s why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks — so you can be ready for where life can take you.

Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world.

Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,500 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com.
 

Olympus…True to You. True to Society. True to LIFE.

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.

Posting Notes: || United States (US) || California (US-CA) || San Jose || 

 


Nearest Major Market: San Jose
Nearest Secondary Market: Palo Alto

Job Segment: Database, Manager, QA, Quality Assurance, Testing, Technology, Management, Quality

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