Top 351 Quality assurance managers Jobs in Somerset, Ma

Quality Assurance Compliance Manager
Aequor Technologies LLC —Fall River, MA
- $86,000 - $113,500 a year
- Supervising experience
- Bachelor's degree
- Senior level
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QA Systems Specialist
Cooperative Production, Inc —Taunton, MA
- $52,000 - $55,000 a year
- Full-time
- Background check
- Clean driving record
- English
- Paid training
- Mileage reimbursement
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5d
Senior Manufacturing Project Manager
General Dynamics Mission Systems, Inc —Taunton, MA
- $130,617 - $144,903 a year
- Full-time
- Engineering
- 3 years
- Master's degree
Production Manager
Confidential —Bristol County, MA
- $120,000 - $140,000 a year
- Full-time
- Background check
- 5 years
- Engineering
- Health insurance
- Dental insurance
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Operations Manager
Amazon.com Services LLC —Taunton, MA
- $91,000 - $136,500 a year
- Weekends as needed
- Mid-level
- Ability to climb stairs
- Bachelor's degree
- AD&D insurance
- Health insurance
13d
Program Operations Manager RP467
People Incorporated —Swansea, MA
- $68,000 a year
- Weekends as needed
- Mid-level
- Residential
- Criminal background check
- Paid holidays
- Disability insurance
Senior Quality Assurance Analyst
Veteran Technology Leaders, LLC —Providence, RI
- $90,000 - $115,000 a year
- Contract
- Hybrid work
- 11+ years
- Children
- Business Administration
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6d
Quality Assurance Quality Control Manager
Zoll Medical Corporation —Pawtucket, RI
- $100,000 - $120,000 a year
- English
- Bachelor's degree
- Travel
Program Manager III, Network Quality
Dana-Farber Cancer Institute —Foxborough, MA
- $108,280 - $118,915 a year
- Full-time
- Hybrid work
- 7 years
- Research
- Analysis skills
Quality Documentation Supervisor
Emerson —Mansfield, MA
- $90,000 - $125,000 a year
- Full-time
- Microsoft Excel
- Management
- Mid-level
- Paid parental leave
- Health insurance
8d
Quality Assurance Manager - Wire and Cable Manufacturing
Atkore —New Bedford, MA
- $112,000 - $154,000 a year
- 7 years
- Engineering
- Travel
- Paid holidays
- Disability insurance
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Food Safety & Quality Assurance (FSQA) Manager
NORPEL Careers —New Bedford, MA
- $90,000 - $120,000 a year
- Weekends as needed
- Spanish
- Writing skills
- English
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Director of ABI
Cooperative Production, Inc —North Dighton, MA
- $86,000 - $90,000 a year
- Full-time
- Background check
- Experience working with individuals with developmental disabilities
- Bachelor of Science
- Paid training
- 403(b) matching
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Regional Quality Manager, Southwest (Remote - Travel Required)
SOLV Energy, LLC —Providence, RI
- $116,812 - $146,016 a year
- Full-time
- Remote
- PMP
- Engineering
- Travel
- Paid holidays
- Disability insurance
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Children's Program House Manager
Crystal Springs Inc. —Assonet, MA
- $54,000 - $58,200 a year
- Full-time
- Mid-level
- Residential
- High school diploma or GED
- Paid training
- AD&D insurance
Quick Apply
Call Center Contact Supervisor
Brown University Health —Providence, RI
- $50,523.20 - $83,345.60 a year
- 8 hour shift
- Hospital
- 5 years
- Computer literacy
Manager, Initiative Test Lead
Fidelity Investments —Smithfield, RI
- Full-time
- 6 years
- Bachelor's degree
- Continuous improvement
Quality Manager
Metals USA —Seekonk, MA
- Full-time
- Schematics
- English
- Mid-level
Project Manager of Integrity & Operations
The Arc of Bristol County dba proAbility —Attleboro, MA
- $75,000 - $82,500 a year
- Full-time
- 5 years
- Bachelor's degree
- Experience equivalent to degree accepted
Quick Apply
7d
FSQ Supervisor
Blount Fine Foods —Warren, RI
- Word processing
- Mid-level
- 1 year
- Disability insurance
- Health insurance
6d

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Quality Assurance Compliance Manager

Aequor Technologies LLC -
Fall River, MA

Quick Apply

Job Details

$86,000 - $113,500 a year

Qualifications

Supervising experience
Bachelor's degree
Leading team collaboration initiatives

Full Job Description

Job Title: Quality Assurance Compliance Manager
Work Location: Fall River, MA
Work Hours: General: 8:30AM – 5:00PM (may vary based on business needs)
Reports To: Head of Quality Assurance

Purpose
The QA Compliance Manager is responsible for ensuring that all compliance related activities comply with U.S. regulatory requirements, primarily governed by the U.S. Food and Drug Administration (FDA) under 21 CFR Parts 210,211 and 820 and other applicable regulations. The role focuses on maintaining inspection readiness, and ensuring adherence to Current Good Manufacturing Practice (cGMP) requirements for pharmaceutical manufacturing.

Job Responsibilities

Ensure timely and effective closure of all internal, external, regulatory, and customer audit observations through robust corrective and preventive actions (CAPA).
Independently prepare, review, and submit Field Alert Reports (FARs) in accordance with FDA regulatory requirements.
Lead and manage initiation and execution of product recalls at various levels, ensuring regulatory compliance and effective cross functional coordination.
Oversee document control operations, ensuring accurate receipt, review, archival, and maintenance of controlled documents in compliance with data integrity and record keeping requirements.
Ensure timely submission of document to iron mount.
Ensure document control room is managed properly and ready for all time audit.
Maintain continuous inspection readiness for internal, external, and regulatory audits through proactive quality oversight and compliance monitoring.
Develop, manage, and execute the site internal audit program, including audit scheduling, conduct, reporting, and follow up activities.
Identify, investigate, and remediate site wide data integrity issues to ensure compliance with regulatory expectations and industry best practices.
Ensure compliance with applicable FDA regulations, including 21 CFR Parts 210 and 211, 21 CFR Part 11 (Electronic Records and Signatures), and 21 CFR Part 820, as applicable.
Interpret and implement FDA guidance documents, compliance policies, and regulatory expectations across site quality systems.
Monitor FDA regulatory updates and industry trends to assess impact and ensure ongoing site compliance and operational readiness.
Serve as the primary Quality Assurance representative and lead during FDA inspections, including Pre Approval Inspections (PAI), routine surveillance, and for cause inspections.
Lead the preparation and submission of responses to FDA Form 483 observations.
Track and manage site-wide training activities to ensure timely completion and maintain zero overdue or pending training requirements, supporting continuous inspection readiness
Collaborate closely with Regulatory Affairs and cross functional stakeholders to align inspection strategies, communication plans, and regulatory responses.
Review FDA Form 483 observations and ensure implementation of agreed corrective actions across the facility.
Coordinate cross functional meetings to drive compliance activities, define action plans, assign responsibilities, and ensure timely completion of commitments and target completion dates (TCDs).
Review the deviation, CAPA and change request initiated against the audit observation to ensure the observation requirements are met.
Impart data integrity and GDP related training to new hire during orientation program.
Investigate and review the market/ product compliant for commercialized product and ensure its onetime closure as per SOP timeline.
Send the compliant related sample to outside vendor for investigation.
Any other work assigned by Head Unit Quality Assurance and Site Quality Head.

Educational & Experience:

Minimum of a bachelor’s degree in chemistry, Pharmaceutical Sciences, QualityManagement or related field of study from an accredited institution.

Minimum of ten (10) years of collective work experience in QA Department, QC lab, preferably in a pharmaceutical manufacturing company preferred.

Minimum of two (2) years supervisory and team leadership experience, both hourly and salaried staff.

Working knowledge and direct application of cGMP and regulatory guidelines related to QA, pharmaceutical manufacturing, and computerized system validation, equipment validation and data integrity.
Relevant understanding and knowledge about CFR part 11 regulations.
Preferably have prior MDI experience or in Drug Device combination products.

#INDQU

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Refine Your Search

quality assurance managers jobs in somerset, ma

Quality Assurance Compliance Manager

QA Systems Specialist

Senior Manufacturing Project Manager

Production Manager

Operations Manager

Program Operations Manager RP467

Senior Quality Assurance Analyst

Quality Assurance Quality Control Manager

Program Manager III, Network Quality

Quality Documentation Supervisor

Quality Assurance Manager - Wire and Cable Manufacturing

Food Safety & Quality Assurance (FSQA) Manager

Director of ABI

Regional Quality Manager, Southwest (Remote - Travel Required)

Children's Program House Manager

Call Center Contact Supervisor

Manager, Initiative Test Lead

Quality Manager

Project Manager of Integrity & Operations

FSQ Supervisor

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