Top 176 Quality assurance Jobs in Danbury, Ct

Manager of Regulatory Affairs & Customer Quality
Forum Contract Manufacturing —Watertown, CT
- $75,000 - $90,000 a year
- Full-time
- Microsoft Excel
- Microsoft Outlook
- Bachelor of Science
- Health insurance
- Dental insurance
Quick Apply
3d
Supplier Quality Manager
Greenfield Global Inc. —Brookfield, CT
- Full-time
- Bachelor's degree
- Senior level
- Leadership
- Disability insurance
- Health insurance
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Quality Engineer
Forum Contract Manufacturing —Watertown, CT
- $75,000 - $90,000 a year
- Full-time
- Research
- Mid-level
- 3 years
- Health insurance
- Dental insurance
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3d
Quality Manager
Saint Gobain —Orange, CT
- $102,000 - $178,500 a year
- Remote
- 5 years
- Bachelor's degree
- Military encouraged
- Wellness program
- Commuter assistance
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Laboratory Technical Assistant 1 - FT - Night - Danbury
Northwell Health —Danbury, CT
- $18.13 - $34.50 an hour
- Full-time
- Hospital
- 3 years
- High school diploma or GED
Quick Apply
Laboratory Technical Assistant 1 - FT - Eve/Night - Danbury
Northwell Health —Danbury, CT
- $18.13 - $34.50 an hour
- Weekends as needed
- Hospital
- 3 years
- High school diploma or GED
Quick Apply
Quality Assurance Supervisor
Lockheed Martin Corporation —Shelton, CT
- Full-time
- Mid-level
- Analysis skills
- Supervising experience
- Paid jury duty
- Paid holidays
Quality Assurance/EHS Supervisor
Primo Brands —Watertown, CT
- $107,101 - $119,916 a year
- Weekends as needed
- English
- Mid-level
- Bachelor's degree
- Commuter assistance
- Health savings account
Specialist II, Quality Assurance Floor (3rd Shift, 10pm - 6:30am, M-F) Contract to Hire
MannKind Corporation —Danbury, CT
- $27.60 - $41.40 an hour
- Monday to Friday
- Bachelor of Science
- Mid-level
- High school diploma or GED
Quick Apply
6d
Manufacturing Quality Engineer
Fortell Research —Danbury, CT
- $95,000 - $130,000 a year
- Full-time
- Engineering
- Mid-level
- 3 years
Director, Quality Systems & Regulatory Affairs (Remote - East Coast)
CEFALY Technology —Darien, CT
- Full-time
- Remote
- Engineering
- Analysis skills
- Mentoring
- Paid holidays
- Disability insurance
Quick Apply
Quality Assurance Engineer
HEALTHPLANONE, LLC —Trumbull, CT
- Full-time
- Computer science
- Computer Science
- Writing skills
- Health insurance
Quick Apply
Quality Control Technician- Third Shift
Laticrete International —Bethany, CT
- $20 - $21 an hour
- 8 hour shift
- Microsoft Excel
- Microsoft Outlook
- Engineering
- AD&D insurance
- Paid holidays
Quality Assurance Inspector (QA Inspector) Full Time - Second and Third Shift
Forum Plastics LLC —Watertown, CT
- $17 - $25 an hour
- Weekends as needed
- Microsoft Outlook
- Computer literacy
- In-person
- Health insurance
- Dental insurance
Quick Apply
Mechanical Source Inspector
Unitek Technical Services —Waterbury, CT
- From $28 an hour
- 8 hour shift
- Mid-level
- 3 years
- US work authorization
- Paid training
- Health insurance
Quick Apply
Quality Control Supervisor (Peekskill, NY)
Jeeter —Peekskill, NY
- $70,304 a year
- Extended hours
- Forklift
- High school diploma or GED
- Supervising experience
- Health insurance
- Dental insurance
Quick Apply
5d
QA Manual SSR
Sofka —Bridgeport, CT
- Hybrid work
Quick Apply
6d
Quality Engineer
Kimchuk Inc —Danbury, CT
- Full-time
- Mid-level
Quick Apply
Quality Document Technician
Straton Industries —Stratford, CT
- $28 - $35 an hour
- Microsoft Outlook
- Basic math
- Administrative experience
Quick Apply
4d
Quality Engineer
Lockheed Martin Corporation —Stratford, CT
- Full-time
- Mid-level
- In-person
- Paid jury duty
- Paid holidays

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Manager of Regulatory Affairs & Customer Quality

Forum Contract Manufacturing
Watertown, CT

Quick Apply

Job Details

Full-time
$75,000 - $90,000 a year
3 days ago

Benefits

Health insurance
Dental insurance
401(k)
Tuition reimbursement
Paid time off
Employee assistance program
Vision insurance
401(k) matching
Professional development assistance
Life insurance

Qualifications

Vendor relationship building
Customer communication
Microsoft Outlook
Manufacturing
Manufacturing company experience

Full Job Description

1.0 PURPOSE

· To ensure organizational compliance with applicable regulatory requirements while managing and improving customer-facing quality processes. This position plays a critical role in maintaining product compliance, supporting regulatory submissions, and serving as the main point of contact for all customer quality concerns, complaints, and audits.

2.0 RESPONSIBILITIES/AUTHORITY

· Responsible for the development, maintenance, and oversight of regulatory and compliance programs.

· Contact person to interface directly with regulatory agencies and customers on matters related to compliance and product quality.

· Works with Quality Engineer as main point of contact for customer quality concerns for the purpose of working on, logging and tracking RCA activities.

· Manages and coordinates customer complaint resolution activities across departments assigning the person(s) responsible for root cause analysis (RCA).

· Manages customer audits and ensures timely and accurate follow-up on findings.

· Advises management on changes to regulatory requirements and their impact on products and operations.

· Ensures the company’s quality and environmental policies are implemented and the requirements of their ISO standards and regulations are met.

· Ensures that the company meets the FDA regulations and requirements as a manufacturer of components or medical devices.

· Ensures that regulations of export control compliance (ITAR and EAR) programs are implemented and are being followed.

· Identifies changes to regulations and next certifications the company should pursue to keep the organization at the forefront of customer requirements, or desired compliance.

· Leads or actively participates in continuous improvement initiatives aimed at enhancing operational efficiency, reducing waste, and driving productivity across the organization.

· Fosters and maintains strong, professional relationships with customers, vendors, and regulatory agencies to ensure alignment, trust, and compliance.

· Promotes a culture of continuous improvement by challenging existing processes and behaviors, encouraging innovation, and reinforcing accountability for enterprise-wide quality and performance excellence.

· Responsible for internal audit programs, training internal auditors, scheduling audits, reviewing reports and corrective actions.

3.0 DUTIES

Regulatory Affairs:

· Prepare, submit, and maintain regulatory filings.

· Management representative and monitor of global regulatory trends and ensure ongoing compliance with applicable standards (FDA, ISO 13485, etc.).

· Maintain and create up-to-date regulatory documentation and support internal/external audits and inspections.

· Collaborate and train product development and quality teams to define regulatory strategies for new and existing products.

· Track and report key quality metrics such as PPM, complaint trends, audit findings, and customer satisfaction indicators.

· Coordinate and host customer quality audits and follow through on required actions and documentation.

· Support the negotiation, review, and execution of customer quality agreements.

· Trains, coaches and mentors’ personnel to raise level of understanding of concepts related to regulatory compliance, quality, environmental systems, internal auditing, and good practices in documentation and manufacturing.

Customer Quality Management:

· Serve as the primary contact and coordinator for customer quality issues/complaints.

· Coordinate root cause analysis and implement CAPAs within the enterprise using cross functional teamwork to maintain high customer satisfaction ratings and implement effective corrective actions.

· Ensure that the documentation control process is implemented and followed by the organization.

· Promotes, leads and participates in quality and continuous improvement activities.

· Serves as liaison to external parties in matters related to quality systems and continuous improvement projects.

· Works with personnel at all levels to solve routine and special issues.

4.0 EDUCATION

· Bachelor of Science Degree preferably in Mechanical or Manufacturing Engineering. An Advanced Degree in related discipline a plus.

· Management and Problem-Solving Techniques courses such as: Certifications in Quality, Lean Manufacturing, Six Sigma, Technical Problem Solving or Root Cause Analysis.

· Training in compliance/regulatory programs a plus.

· Certified ISO 13485 Lead Auditor a plus.

5.0 EXPERIENCE

· 10 + years in management level regulatory or quality assurance roles in a manufacturing operation setting with a diverse well-rounded background.

· Minimum of 5 years in Quality administration or engineering role. Experience as Quality Manager and understanding of ISO Quality systems required.

· Knowledge of plastic injection molding processes related to medical devices a plus.

· Strong knowledge of safety procedures and policies a plus.

· Microsoft Office skills required (Excel, Word, PowerPoint, Outlook, etc).

6.0 PERSONAL CHARACTERISTICS

· Highly organized, a positive attitude with attention to detail.

· A highly self-motivated person.

· Willingness to learn and evolve skillsets.

· Excellent written and verbal communication skills.

· Strong interpersonal skills and a team builder.

7.0 REPORTING RELATIONSHIP

· President, Director of Engineering, Director of Operations

Pay: $75,000.00 - $90,000.00 per year

Benefits:

401(k)
401(k) matching
Dental insurance
Employee assistance program
Health insurance
Life insurance
Paid time off
Professional development assistance
Tuition reimbursement
Vision insurance

Work Location: In person

Quick Apply

Refine Your Search

quality assurance jobs in danbury, ct

Manager of Regulatory Affairs & Customer Quality

Supplier Quality Manager

Quality Engineer

Quality Manager

Laboratory Technical Assistant 1 - FT - Night - Danbury

Laboratory Technical Assistant 1 - FT - Eve/Night - Danbury

Quality Assurance Supervisor

Quality Assurance/EHS Supervisor

Specialist II, Quality Assurance Floor (3rd Shift, 10pm - 6:30am, M-F) Contract to Hire

Manufacturing Quality Engineer

Director, Quality Systems & Regulatory Affairs (Remote - East Coast)

Quality Assurance Engineer

Quality Control Technician- Third Shift

Quality Assurance Inspector (QA Inspector) Full Time - Second and Third Shift

Mechanical Source Inspector

Quality Control Supervisor (Peekskill, NY)

QA Manual SSR

Quality Engineer

Quality Document Technician

Quality Engineer

I want to receive the latest job alert for quality assurance in danbury, ct

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