Project Manager - QMS
California, Pennsylvania, United States of America
Contract
3 weeks ago
$70 USD
Key skills
LeadershipStakeholder ManagementRisk ManagementChange ManagementCommunicationSales
About this role
Technical Project Manager - QMS Transformation
Santa Clara, CA | Hybrid (3 days/week)
Long Term Contract
$75-80/hr (Negotiable)
ABOUT THE ROLE
Our client is seeking a Senior Technical Project Manager to lead a large-scale Quality Management System (QMS) transformation initiative in Santa Clara, CA, on a hybrid schedule. This highly visible, long-term contract role involves driving the sunset of legacy QMS platforms and implementing new enterprise QMS solutions across multiple business capabilities. The Project Manager will play a critical role in platform selection, deployment planning, and execution, overseeing the migration of key quality processes such as CAPA, Non-Conformance, Audit, Field Actions, Complaints, Supplier Quality, and Approved Supplier List. This position requires strong expertise in enterprise system deployment, stakeholder alignment, and regulated quality environments. The Project Manager will ensure cross-functional stakeholder alignment, manage multiple workstreams, provide executive-level reporting, and ensure compliance with FDA, ISO, and quality system requirements. Additional responsibilities include vendor management, system validation, audit readiness, and supporting change management and training initiatives.
WHAT YOU'LL DO
Disclaimer: Brooksource, Medasource, and Calculated Hire are part of the Eight Eleven Group family of companies and operate under Eight Eleven Group, LLC. All employees receive the same benefits, policies, and terms of employment.
EEO: We are committed to creating an inclusive environment for all employees and applicants. We do not discriminate on the basis of race, color, religion, creed, sex, sexual orientation, gender identity or expression, national origin, ancestry, age, disability, genetic information, marital status, military or veteran status, citizenship, pregnancy (including childbirth, lactation, and related conditions), or any other protected status in accordance with applicable federal, state, and local laws.
Benefits & Perks: Brooksource offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee's needs. We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company holidays. We also offer an Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.
Pay Disclaimer: The pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.
#LI-MR1
Santa Clara, CA | Hybrid (3 days/week)
Long Term Contract
$75-80/hr (Negotiable)
ABOUT THE ROLE
Our client is seeking a Senior Technical Project Manager to lead a large-scale Quality Management System (QMS) transformation initiative in Santa Clara, CA, on a hybrid schedule. This highly visible, long-term contract role involves driving the sunset of legacy QMS platforms and implementing new enterprise QMS solutions across multiple business capabilities. The Project Manager will play a critical role in platform selection, deployment planning, and execution, overseeing the migration of key quality processes such as CAPA, Non-Conformance, Audit, Field Actions, Complaints, Supplier Quality, and Approved Supplier List. This position requires strong expertise in enterprise system deployment, stakeholder alignment, and regulated quality environments. The Project Manager will ensure cross-functional stakeholder alignment, manage multiple workstreams, provide executive-level reporting, and ensure compliance with FDA, ISO, and quality system requirements. Additional responsibilities include vendor management, system validation, audit readiness, and supporting change management and training initiatives.
WHAT YOU'LL DO
- Lead the end-to-end transition of legacy QMS applications to new platforms
- Manage migration of key QMS capabilities including CAPA, Non-Conformance (NC), Audit, Field Actions, Complaints, Supplier Quality, and Approved Supplier List
- Develop and execute deployment strategies, roadmaps, and rollout plans
- Drive system implementation across internal enterprise platforms or external solutions
- Establish governance, risk management, and reporting frameworks
- Drive cross-functional alignment across IT, Quality, Regulatory, Engineering, Operations, and Sales teams
- Manage multiple concurrent workstreams and deployments
- Provide executive-level reporting and decision support, ensuring adherence to PMO standards and best practices
- Act as primary point of contact for software vendors and implementation partners, managing deliverables, timelines, and performance
- Coordinate across internal and external implementation teams
- Develop and execute communication and change management strategies
- Ensure training planning, coordination, and completion tracking
- Partner with SMEs or vendors for training delivery
- Ensure alignment with FDA, ISO, and quality system requirements
- Support system validation and audit readiness
- Partner with IT and data teams on migration and architecture
- Define and track KPIs for adoption and operational impact
- 8-10+ years of technical project/program management experience
- Experience leading enterprise system implementations or migrations
- Experience with QMS or quality system processes (CAPA, NC, Audit, Complaints)
- Strong governance, stakeholder management, and leadership skills
- Experience managing vendors and system integrators
- Bachelor's degree required
- PMP or Process Excellence certification (e.g., Six Sigma) required
- Experience with QMS platforms (e.g., ETQ, ComplianceQuest) preferred
- Medical device, MedTech, or regulated industry experience preferred
- Knowledge of system validation and regulatory environments preferred
- Experience with large-scale application transformations preferred
- Spanish language skills a plus
Disclaimer: Brooksource, Medasource, and Calculated Hire are part of the Eight Eleven Group family of companies and operate under Eight Eleven Group, LLC. All employees receive the same benefits, policies, and terms of employment.
EEO: We are committed to creating an inclusive environment for all employees and applicants. We do not discriminate on the basis of race, color, religion, creed, sex, sexual orientation, gender identity or expression, national origin, ancestry, age, disability, genetic information, marital status, military or veteran status, citizenship, pregnancy (including childbirth, lactation, and related conditions), or any other protected status in accordance with applicable federal, state, and local laws.
Benefits & Perks: Brooksource offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee's needs. We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company holidays. We also offer an Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.
Pay Disclaimer: The pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.
#LI-MR1