Quality Data Analyst II

Description

Position Overview

The Quality Data Analyst II will establish, collect, analyze, report, and monitor data and key process metrics related to Quality Management System (QMS). The

general scope of this position will be related to analysis of QMS data and identification of any patterns within the data using statistical control charts, Pareto's, etc. and utilizing high-quality data presentation skills to ensure information is presented in a clear and concise manner. This role will also provide support as needed for review of quality data for input into various quality metrics/reports within the QMS. This work is accomplished with guidance from management and requires a motivated, self-starter who can work independently.

Essential Job Functions

• Develop and perform effective data analysis and visualization for all elements of the QMS and processes in an accurate and timely manner

o Develop and generate reports and analysis

o Create presentations based on the data sets

o Collaborate with various functional teams to collect and analyze data

o Use graphs, infographics, and other methods to visualize data

o Collect and analyze QMS data for Management Review and other periodic

reviews

o Incorporate state of the art data analysis and visualization tools

• Provide support as needed for periodic analysis and review of QMS data such as data

for final product release activities, non-conformance system management, CAPA, audits,

supplier performance, service order requests etc.

• Support Quality Compliance activities by extracting and analyzing post market

surveillance (PMS) data to support the PMS plans/reports, Periodic Safety Update

Reports for submission to regulatory bodies

• Support comprehensive literature searches, review of complaints, CAPAs and adverse

event and clinical databases and develops methods to efficiently extract and summarize

in a report for Shockwave Medical devices or similar devices

• Assist in establishing Key Performance Indicators (KPIs) to measure effectiveness of the

QMS processes

• Identify and develop data points within the QMS processes to enable data analysis and

monitoring against key performance indicators

• Assist in monitoring, detecting quality and safety signals associated with product

performance, and overall aspect of the Quality Management System (QMS) and Risk

Management System

• Assist functional teams to identify opportunities for improvement

• Assure data integrity and data validation prior to publishing reports and analysis

• Process confidential data and information according to guidelines

• Manage and design the reporting environment, including data sources, security, and

metadata

• Support the data warehouse in identifying and revising reporting requirements

• Support initiatives for product performance and QMS data integrity

• Support implementation of the new/upgraded software, new products, and new country

requirements

• Troubleshoot the reporting database environment and reports

• Develop dashboards for ease of data visualization

• Train end-users on new reports and dashboards

• Provide technical expertise in data storage structures, data mining, and data cleansing

• Identify and drive QMS continuous improvement activities

• Support company goals and objectives, policies, and procedures, QSR, and FDA

regulations

• Other duties as assigned

Skills

Data, Data entry, Quality assurance

Additional Skills & Qualifications:

Requirements

• Bachelor's degree in computer science, statistics, mathematics or related areas

• Minimum 2+ years' experience directly supporting QMS data analysis, or relevant

experience in medical/scientific area

• Strong background in statistics

• Required knowledge of Medical Device Quality Systems (FDA QSR, ISO 13485, EU

MDR etc.)

• Ability to work effectively with cross functional teams to assess potential risks

• Ability to analyze existing tools and databases and provide software solution

recommendations

• Ability to translate business requirements into non-technical terms

• High-level experience in methodologies and processes for managing large-scale

databases

• Demonstrated experience in handling large data sets and relational databases.

• Excellent critical thinking skills

• Effective written, verbal and presentation skills with all levels of management and

organizations

• Advanced Microsoft Excel and PowerPoint skills with the ability to manipulate data and

use advanced formulas

• Operates both as a team and independently, with adaptability to changing requirements

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email ~~~ (~~~) for other accommodation options.