Lead Analyst, ConvergeHEALTH SaMD Quality Systems
Boston, MA

Job Description

Lead Analyst, ConvergeHEALTH SaMD Quality Systems:

ConvergeHEALTH by Deloitte

Location: Boston, MA or Northeast

Overview

Deloitte Consulting's Platforms practice develops products that augment our leading services practice and strike at the heart of our clients' business needs. ConvergeHEALTH is an innovation unit within Deloitte Consulting's Platforms practice and supports data-driven transformation of healthcare by enabling healthcare and life sciences organizations to answer the "hard questions" -what works, for whom, why, in what context, and at what cost?

The Quality Management System (QMS) Engineer will be a key member of the ConvergeHEALTH practice within Deloitte Consulting.

As part of QMS at ConvergeHEALTH at Deloitte, this role can not only lead the changes in ConvergeHEALTH Quality Management System (QMS) adapting to a changing regulatory and compliance environment but help implement solutions while gaining hands-on experience working alongside ConvergeHEALTH product engineering teams to build the software products that meet the needs for regulated systems and Software as a Medical Devices (SaMDs). You will have the opportunity to build your professional skills in a variety of project experiences and be involved in helping our clients understand, assess, and leverage ConvergeHEALTH QMS for their needs for regulated systems and SaMD.

* Ensures documentation and practices meet quality standards, applicable regulatory compliance and company guidelines/policies.
* Review functional or technical requirement documents and develop test cases to the stated requirements including positive and negative testing.
* Review the accuracy and completeness of software validation deliverables created by other process teams (e. g., Requirements, IQ, OQ, UAT, Data Migration, SOPs, and Work Instructions)
* Create Traceability Matrices linking approved requirements to test cases in Atlassian Jira (both automated and manual).
* Works with fellow validation and project team members in a dynamic environment with shuffling priorities and responsibilities.
* Provide expertise in the review of all deliverables across the project lifecycle, ranging from requirements documentation to final protocol reports.
* Keeps the validation lead informed of any issues regarding the quality of the deliverables, or any potential sources of impact to the project timeline.
* Accurately report the status of assigned deliverables and support other compliance work as necessary.
* Support client assessments of ConvergeHEALTH QMS as it pertains to requirements for development of regulated systems and SaMDs
* Work with clients to setup the ConvergeHEALTH QMS for their internal use to supplement existing quality systems using Tools including Atlassian Jira and Confluence.

Preferred Skills and qualifications:

* Experience in Life Sciences Industry, functional knowledge of Pharmaceuticals, Biologics, Medical Devices & Diagnostics and FDA regulations, knowledge of analytics and reporting tools, strong communication skills, proficiency in MS Office suite.
* Firm understanding and practical experience with FDA GxP regulations and some of the following: EMEA, 21 CFR Part 820, 21 CFR Part 11, ISO, MHRA, ISO 13485, IEC 62304 and 510(k) Submission Process
* Industry sub segment experience (e. g., pharmaceutical, medical device, biotechnology) in the areas of manufacturing, quality assurance/quality control or regulatory compliance
* Operational area (e. g., R&D/clinical, operations/manufacturing, quality assurance/control, IT, supply chain, commercial)
* Process knowledge and experience (e. g., drug safety/pharmacovigilance, product life cycle management, computerized system validation, manufacturing execution, quality systems, IT quality systems, aggregate spend, records management)
* Functional or technical computer system knowledge and experience (e. g., EDMS, EQMS, SAP, Oracle, LIMS, Documentum, MES, PLM)
* Specific quality business process knowledge and experience (e. g., adverse event reporting, change control, document management, CAPA, product testing, GMO auditing, risk assessments)
* Demonstrate ability to analyze problems, develop solutions, and communicate results
* Complex problem-solving abilities across operational, organizational, and strategic matters
* Strong communication (both written and verbal English), and organizational and interpersonal relationship-building skills
* Must have high energy and flexibility to work effectively in a fast-paced environment; team player; positive attitude
* Ability to work independently and under general direction with a strong sense of motivation to succeed.
* Travel up to 50%

As used in this posting, "Deloitte" means Deloitte Consulting LLP, a subsidiary of Deloitte LLP. Please see www.deloitte.com/us/about for a detailed description of the legal structure of Deloitte LLP and its subsidiaries. Certain services may not be available to attest clients under the rules and regulations of public accounting.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or protected veteran status, or any other legally protected basis, in accordance with applicable law.

Requisition code: E20BOSCACSJG007-DP-C

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