Vensure Employer Solutions · 3 months ago
Senior Manager, Quality and Regulatory - MA - On Site
Franklin, MA
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expVensure Employer Solutions is a dynamic, global company seeking a Senior Manager in Quality and Regulatory Assurance. This role is responsible for implementing and executing the Quality program across all products and services, ensuring compliance with quality standards and addressing quality issues in collaboration with various teams and customers.
Customer ServiceFinancial ServicesHuman ResourcesRisk Management
Responsibilities
Provide strategic leadership for the Quality Control Program to ensure all products, raw materials, processes and services meet the Company's exceptionally high-quality standards
Ensure company compliance with accredited quality systems: 21 CFR part 820, ISO 13485, and applicable EU, UK, and Australian requirements
Continue to strategically evolve company quality system as well as transition system with revisions of standards
Acts as Management Representative and performs all duties and tasks associated with that designation. Acts a PRRC for European compliance
Lead company audits either by accreditation bodies or by customers
Work with the appropriate teams to ensure proper action is taken and that the steps are initiated to avoid repeat errors
Maintain documentation and revision level of quality documentation for all products or services
Maintain and communicate all quality data to department managers for problem identification, resolution, loss reporting
Report company quality data including complaints, nonconforming product, and corrective/preventive action activities
Review non-conformities (NCRs) for determining root cause, creating corrective actions, providing customer follow up and close NCRs within an acceptable timeframe
Perform problem-solving tests to develop corrective actions for quality issues and to initiate continuous improvement
Report Quality metrics and trends routinely to the company
Conduct routine quality checks of product on the productions floor and report errors and process improvement recommendations
Coordinate returns to vendors and ensure corrective actions are in place to prevent future defects
Performs other duties as assigned
Qualification
Required
Bachelor's degree from an accredited higher learning institution, preferably in a Quality or Engineering related field
Experience in high volume manufacturing environment, preferably in medical devices or in-vitro diagnostics
Experience with European IVDD and IVDR compliance and regulations
Experience with FDA 21 CFR Part 820 regulations
Minimum of 10 years' experience related to quality assurance, lean manufacturing, regulatory compliance, and/or Six Sigma manufacturing
Holds Quality certifications in one or more of the following: ASQ/CQE, CMQ/OE, Six Sigma (Green or Black Belt)
Hands-on approach to troubleshoot and resolve quality related issues
Detail and Quality focused with strong organization, persuasion and negotiation skills
Ability to present information and respond to questions from various levels within the organization
Proficient in the use of MS Office
Thrives in a fast-paced, collaborative environment, efficiently works under pressures, within deadlines or other time essential constraints
Excellent communication skills, both written and verbal, to clearly and concisely communicate to all levels of the organization
Strong work ethic and an ability to excel within a rapidly changing and growing organization
Company
Vensure Employer Solutions
Vensure Employer Solutions is a privately owned professional employer organization (PEO) headquartered in Chandler, Arizona, with offices in Sarasota, Florida, and Duluth, Georgia.
1001-5000 employees
H1B Sponsorship
Vensure Employer Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2023 (1)
2022 (2)
Funding
Current Stage
Late StageTotal Funding
$2.2BKey Investors
Stone Point Capital
2024-10-14Debt Financing· $2.2B
2022-09-06Acquired
Leadership Team
A
Alex Campos
CEO
Pat Cleary
Chief Growth Officer
Recent News
Sports Business Journal
2025-10-24
bloomberglaw.com
2025-09-12
Company data provided by crunchbase