Data Management Quality Engineer - Remote

Working Location: PENNSYLVANIA, CENTER VALLEY; Nationwide 

Workplace Flexibility: Field

Are you looking for a company that cares about people’s lives and health, including yours? Let’s inspire healthier lives, together.

 

Olympus, a leading medical technology company, has focused on making people’s lives better for over 100 years.

Our Purpose is to make people’s lives healthier, safer, and more fulfilling.

 

Our Core Values are reflected in all we do: Integrity – Empathy – Agility – Unity – Long-Term View

 

We deliver on our purpose and our core values by staying True to Life.

Job Description

The Data management Quality Engineer is responsible for analysing and interpreting quality metric data relating to all data quality sources across Americas, EMEA, Japan, China, and APAC region.

 

The Data management Quality engineer has a pivotal role in determining requirements to provide standardized data sets to support reporting, presentations, and review of data by top management. 

 

As Data Management Quality engineer will partner close with other Quality and cross-functional leaders at site and global levels to analyze data related the NC/CAPA and enable a timely completion of inputs to the CAPA Review Board.

 

This position will be instrumental in identifying trends, implementing solutions, and managing Data Management projects within the realm of data analytics, CAPA, and NC. 

Job Duties

• Identify requirements for quality metric data for NC/ CAPA Review Board and works with cross-functional stakeholders to develop solutions.
• Collaborate with the QA/RA Strategic team to align the CAPA/NC metrics.
• Oversee the management of the use of quality metric data into NC/ CAPA Review Board 
• Uses quality metric data to analyse, interpret and identify trends from over 100 sites
• Identify gaps and areas for actions, including a heat map for data
• Coordinates content for NC/CAPA Review Board across site and global level including data from site level reviews
• Performs ad hoc queries to analyse trends on metrics or processes.
• Takes initiative to analyse data from tiered or site level reviews for escalation.
• Follow-up and tracking of outputs and actions for completion.
• Supports the creation of content for the Global CAPA Review Board.
• Communicate with each site to promote and select escalated data for the Global CAPA Review Board 
• Develops and fosters working relationships with colleagues globally to drive standardization, collaboration, and support growth across Olympus.
• Participates in Quality initiatives as a cross functional contributor.
• Demonstrate operational excellence and ensure quality in all deliverables.
• Supports CAPA investigations & audit requests (internal & external)
• Support audits as a Subject Matter Expert for data analytics relating to NC/CAPA Review Board, as required.
• All other duties as assigned.

Job Qualifications

Required:

• Bachelor of Science, medical, engineering, or scientific discipline. Black Belt / Green Belt certification. Statistical techniques.
• Minimum of 5 years’ experience in a drug/device manufacturer with demonstrated results in effective CAPA process to International Regulations and standards.
• Comprehensive understanding of global regulatory standards, including ISO 13485:2016, ISO 9001:2015, and FDA Quality System Regulation
• Strong SQL or Excel skills, with aptitude for learning other analytics tools.
• Strong mathematical skills to help collect, measure, organize and analyze data.
• Proficiency in statistics and statistical packages like Excel, and Minitab to be used for data set analyzing.
• Knowledge of data visualization software like Tableau, Qlik, Power BI and programming languages
• Competent with Microsoft Office 365 Suite, Visio, Adobe, DocuSign, Agile, ERP systems and Windows platforms and other platforms e.g., SAP 
• Competent understanding of International medical device regulations specific expertise in; Regulatory Inspections, CAPA policy development & implementation, Mentoring and Coaching of teams, Strong analytics driving proactive solutions and demonstrated enhancements on CAPA principles.
• Global working hours
• Occasionally international travel