Data Analyst - San Francisco

Company: MedTech Talent
Your Application: You have not applied yet
Location: San Francisco, USA
Employer Email: *********@*******.com (View email)
JOB DESCRIPTION

Data Analyst

South San Francisco/Remote PST

Our client is based in South San Francisco, CA, and is a U.S. subsidiary of a multi-national organization headquartered in Tokyo, Japan. Established in the United States in 1989, Our client has become known throughout the Americas for providing sophisticated diagnostic systems to doctor's offices, hospitals, and reference laboratories. They remain at the forefront with a world-class network of research facilities, scientists, engineers, and customer support specialists.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Create, build, and conduct monthly complaint trend analysis reports and quality metrics for the organization’s Trending Review Board (TRB) and cross-functional teams for management decision-making.Develop and monitor quality metrics for complaint handling process and related processes.Responsible for generating and delivering ongoing and ad-hoc reports to internal customers who might require complaint data and information for investigations, CA/PAs etc.Develop and implement data analyses, data collection systems, and other strategies that optimize statistical efficiency and quality compliance.Identify, analyze, and interpret trends or patterns in complex data sets using statistical techniques.Support data analysis for Corrections & RemovalsMonitor, identify, and define/recommend new process improvement opportunities and solutions for compliance, cost-saving, and standardization for the organization.Project manager for data-driven process improvement opportunities with a Lean focus.Support validation activities associated with software tools used for complaint handling and regulatory reporting in accordance with regulatory requirements.Participate in external and internal regulatory audits as required for matters related to Technical Service, Complaints, Regulatory Reporting, and Corrections & Removals.As needed, coordinate the identification, assignment, monitoring, and completion of process improvement projects in cross-functional teams.Provide guidance and training to internal customers, as related to quality complianceAct as the liaison between internal customers and the Complaint / Compliance team regarding complaint data.Support all audit activities.Support MDR filings as neededOther duties as assigned by the manager

FDA / REGULATORY RESPONSIBILITIES

Provide data analysis as requested by FDA, regulatory agencies, notified body, and/or as requested by management

Participate in FDA and regulatory agency inspections (e.g. MDSAP, ISO) as required

QUALIFICATIONS

Bachelor's Degree in a science-related field, engineering/mathematics, business analytics – biological science a plus; MBA preferred. ASQ CQPA, CQM, CSSGB, CSSBB a plusAn in-depth understanding of FDA regulations and ISO standards is required with a minimum of 5 years of experience in the IVD and medical device industry.Strong knowledge and experience with ISO14971, ISO 13485:2016, 21 CFR Part 820, Part 806, Part 11 (Electronic Signatures)Strong knowledge of and experience with reporting packages CRMs such as Sales Logix.Extensive experience with Excel and Minitab
applications including knowledge of statistical methods including Trend Analysis, Pareto, SPC, Pivot tables, data analysis, and being a data generalist.Apply sound, systematic, scientific, data-driven problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.The ability to communicate Quality System requirements and manage compliance with the same is expected.Must work across functional teams within the organizationAttention to detail and timeliness is critical and a must.Excellent communication (verbal and written) and interpersonal skills are required; this role will require creating quality reports and presentations for executive management.Must be a self-directed and independent thinker.Demonstration of technical, team, and solution leadership through strong communication skills to recommend actionable, data-driven insights.Strong project management skills, PMP certification a plus.Proven use of continuous improvement tools, such as Lean and Six Sigma, including Statistical Analysis Methodologies and Quality tools (SPC, Ishikawa, C&E, etc.).Prefer knowledge and experience with Complaints database compliance, including software V&V and change management activities.Proficient computer skills (MS Office)Fluent in English. Knowledge of Japanese is a plus.


SUPERVISORY RESPONSIBILITIES INCLUDE

Provide oversight of data requestsPrioritize resources work and provide feedback to requestorsCoordinate with Lead Technical Support Specialist with ticket assignmentsSchedule and manage weekly compliance meetings for review of data & assignments


TRAVEL RESPONSIBILITIES

Minimal (5 – 15%)

WORKING CONDITIONS

This position may require visits to customer sites which are medical facilities. These facilities may have certain requirements which company representatives must meet to gain access, including the requirement for drug, background, and health screening. Employment is contingent on your compliance with the requirements established by each facility, as evidenced by the results of the required screenings.Must agree to provide required immunization records and/or agree to acquire required immunizations in order to gain access to customer sites as required by customers. You may be required to register at vendor credentialing


PHYSICAL AND ENVIRONMENTAL DEMANDS

To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required to be successful. Additional duties may be assigned in the future as required. Reasonable accommodations may be made for those individuals with disabilities in order to perform the essential functions.

The client is an Equal Opportunity Employer M/F/Disabled/Veterans




JOB TYPE
Work Day: Full Time
Employment type: Permanent Job
Salary: Negotiable


JOB REQUIREMENTS
Minimal experience: Unspecified



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