Top 35 Quality manager Jobs in Ridgeville, Sc

Quality & Regulatory Affairs Manager
Sterimed Inc. —Ridgeville, SC
- $75,000 - $100,000 a year
- Full-time
- Spanish
- Microsoft Excel
- 5 years
- Relocation assistance
- Health insurance
Quick Apply
7d
Quality Control Manager
Freeman Boatworks —Moncks Corner, SC
- Background check
- Pass drug screening
- Supervising experience
- Paid holidays
- Disability insurance
Quality Associate Manager
Quikrete – Cement —Harleyville, SC
- Online Application
- Customer service
- Mid-level
- Bachelor's degree
- Health insurance
- Dental insurance
Quick Apply
7d
Lead, Quality Systems - Day Shift
GXO Logistics —Moncks Corner, SC
- Day shift
- Hybrid work
- Computer literacy
- Pass drug screening
- Mid-level
- Disability insurance
- Health insurance
Quality Control Manager
Trident Construction —North Charleston, SC
- Weekends as needed
- Construction site
- Ability to walk for extended periods
- Pass drug screening
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Center Quality Manager 1
Octapharma —North Charleston, SC
- Weekends as needed
- Computer literacy
- Bachelor of Science
- Bachelor's degree
- Wellness program
- Health savings account
Quality Control Supervisor
Thorne —Summerville, SC
- Overnight shift
- Management
- Supervising experience
- Mentoring
- Paid holidays
- Disability insurance
2d
Quality Control Manager/Site Safety Health Officer
Outside The Box —Charleston, SC
- $90,000 - $130,000 a year
- 8 hour shift
- CPR Certification
- Clean driving record
- Construction site
Quick Apply
Strategic Clinical Quality Manager - South Carolina Region
Fresenius Medical Care —North Charleston, SC
- Full-time
- Hybrid work
- Nursing
- RN License
- 3 years
Quality Control Inspector Lead
Thorne —Summerville, SC
- Full-time
- Basic math
- Mid-level
- High school diploma or GED
- Paid holidays
- Disability insurance
2d
Technical Services Manager
Voith Group —Summerville, SC
- 5 years
- Engineering
- English
- Tuition reimbursement
- 401(k) matching
23h
Quality Control Team Lead
Palmetto State Armory L —Summerville, SC
- Full-time
- 18 years or older
- Microsoft Excel
- Microsoft Outlook
Quick Apply
Fuels Site Superintendent/Quality Control Manager
Tepa LLC —North Charleston, SC
- $100,000 - $145,000 a year
- 8 hour shift
- CPR Certification
- Microsoft Excel
- Construction site
- Health savings account
- Paid holidays
Quick Apply
Quality Control Shift Manager, 3rd Shift
AOCUSA —North Charleston, SC
- Overtime
- Mid-level
- 3 years
- Master's degree
- Profit sharing
- Paid holidays
Quick Apply
Construction Quality Control Manager - Healthcare
RQ Construction —North Charleston, SC
- $130,000 - $160,000 a year
- Full-time
- Microsoft Outlook
- Construction site
- Computer literacy
- Health savings account
- Health insurance
Quick Apply
3d
Quality Technician Team Lead
Keel —Goose Creek, SC
- Microsoft Word
- Management
- Computer literacy
- Paid training
- Health savings account
Quick Apply
Dental Lab Manager Technician
Affordable Care, LLC —Ladson, SC
- Full-time
- High school diploma or GED
- Supervising experience
- Mentoring
- Paid holidays
- Health insurance
Quick Apply
Director Quality and Compliance - Hospice
Spartanburg Regional Healthcare System —Drayton, SC
- Full-time
- Nursing
- RN License
- Master's degree
Quick Apply
8d
Contractor Quality Assurance/Control Supervisor - Landfill Construction/Cap Construction
Ayuda Companies —United States
- $90,000 - $120,000 a year
- Full-time
- Background check
- Construction site
- Pass drug screening
- Disability insurance
- Health insurance
Quick Apply
Real Estate Listing Agent - High Quality Leads Provided!
ADT Realty —United States
- $80,000 - $250,000 a year
- Full-time
- Remote
- Mid-level
- Real Estate License
- Referral program
Quick Apply

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quality manager jobs near ridgeville, sc

Quality & Regulatory Affairs Manager

Sterimed Inc.
Ridgeville, SC

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Job Details

Full-time
$75,000 - $100,000 a year
7 days ago

Benefits

Relocation assistance
Health insurance
Dental insurance
401(k)
Paid time off
401(k) matching
Life insurance

Qualifications

Microsoft Excel
GMP
Team development
Production validation processes
Bachelor's degree
Medical device manufacturing facility experience
Recruiting
Regulatory/legal compliance standards in production
Cleanroom experience
Biomedical regulatory compliance
Quality audits

Full Job Description

Quality & Regulatory Affairs Manager

Our Adventure

STERIMED US is the American operation of the Sterimed Group, a global leader in sterile barrier systems and integrated medical packaging solutions serving the medical device, pharmaceutical, and life sciences industries.

We combine global expertise with local responsiveness to help customers protect product integrity, simplify supply chains, and support regulatory compliance. Our expanding capabilities include ISO Class 7 and 8 cleanroom assembly and packaging, contract manufacturing, Form-Fill-Seal packaging, ultrasonic cleaning, kitting, sterilization management, and comprehensive packaging solutions tailored to the evolving needs of the medical device and life sciences industries.

As we continue to invest in new cleanroom facilities, advanced manufacturing technologies, and value-added services across the United States, we're building a team passionate about innovation, quality, and operational excellence. If you're looking to make a meaningful impact in a fast-growing organization backed by a global leader, we'd love to hear from you.

Summary of position

The Quality & Regulatory Affairs Manager is responsible for leading quality management system execution, FDA QMSR / 21 CFR Part 820 and ISO 13485 compliance, validation activities, and implement regulatory compliance strategies within medical device and sterile barrier packaging environment. This role supports the development, transfer, validation, and scale-up of manufacturing and contract packaging processes while ensuring compliance with FDA, ISO 13485, cGMP, and Sterimed Quality System requirements.

This position serves as a cross-functional leader between Quality, Operations, Production Planning, Engineering, Sales, Regulatory, and site leadership to convert business and technical requirements into compliant, validated, and production-ready processes. The role is responsible for quality oversight, process documentation, validation documentation, Regulatory affairs project execution (510(k) Submission), continuous improvement, and support of audits, inspections, and management review activities.

Your Responsibilities

Act as Management Representative in accordance with ISO 13485 and support ongoing compliance with applicable FDA, ISO, cGMP, and regulatory requirements.
Maintain FDA establishment registration and support regulatory documentation, audits, inspections, and technical due diligence activities.
Support the development, transfer, validation, and scale-up of manufacturing and contract packaging processes.
Lead IQ/OQ/PQ activities in coordination with the Sterimed Group Validation Engineer and ensure new or revised processes are properly qualified before implementation.
Develop and manage project plans, timelines, risk registers, action plans, gate reviews, and project status updates.
Support manufacturing and Quality Control activities related to incoming inspection, in-process controls, final release, LHR review, efficiency improvement, and waste reduction.
Manage NCMRs, NCRs, complaints, CAPAs, SCARs, training records, DCRs, deviations, and quality

events within the eQMS.

Lead Quality Management Review preparation and communicate Quality, Regulatory, Validation, Project, and Safety KPIs to site leadership.
Support technical problem solving, root cause analysis, continuous improvement, and implementation of corrective and preventive actions.
Maintain strong communication with internal stakeholders including Operations, Planning, Finance, Sales, Quality, Regulatory, and site leadership.
Oversee the daily workflow of assigned Quality and/or project-related functions to ensure operational excellence and compliance.
Recruit, interview, train, develop, and evaluate assigned staff as applicable.

Your skills

Strong knowledge of quality systems, regulated manufacturing, validation, and project management.
Well-organized, self-directed, and able to manage multiple priorities and deadlines.
Strong technical writing, documentation, and problem-solving skills.
Effective leadership skills, including coaching, delegation, and team development.
Strong cross-functional communication skills with the ability to work across Quality, Operations, Engineering, Sales, Regulatory, and leadership teams.
Comfortable working in a fast-paced, growth-oriented, multicultural environment.
Proficient with Microsoft Office, ERP/business systems, and eQMS or related quality software.
Fluent in written and spoken English. Spanish and/or French is a plus.

Your qualifications

Minimum Bachelor’s degree in a scientific, technical, engineering, manufacturing, packaging, or related field; equivalent experience may be considered.
Minimum 5 years of experience in medical device, GMP, regulated manufacturing, quality, validation, project management, or related technical operations.
Experience with medical device quality systems, preferably in an environment with on-site manufacturing or contract packaging.
Strong working knowledge of ISO 13485, FDA QMSR / 21 CFR Part 820, ISO 14971, validation principles, and good documentation practices.
Direct experience supporting audits, regulatory inspections, customer audits, or quality system assessments.
Experience with IQ/OQ/PQ, process validation, CAPA, NCMR, DCR, training, and eQMS workflows.
Experience with project management, Gantt chart creation, and project management software.
Preferred experience with sterile barrier systems, cleanroom packaging, pouching, tray sealing, thermoforming, medical device packaging, or contract manufacturing.
Preferred experience supporting technology transfer, new product/process introduction, cost modeling, or CapEx justification.
PMP certification preferred.

Sterimed is committed to creating an inclusive and accessible work environment. Feel free to let us know about any accommodations you may need to participate in the recruitment process.

Job Type: Full-time

Pay: $75,000.00 - $100,000.00 per year

Benefits:

401(k)
401(k) matching
Dental insurance
Health insurance
Life insurance
Paid time off
Relocation assistance

Education:

Bachelor's (Preferred)

Experience:

Microsoft Excel: 2 years (Preferred)
Medical Device/GMP: 1 year (Preferred)

Work Location: In person

Quick Apply

Refine Your Search

quality manager jobs in ridgeville, sc

Quality & Regulatory Affairs Manager

Quality Control Manager

Quality Associate Manager

Lead, Quality Systems - Day Shift

Quality Control Manager

Center Quality Manager 1

Quality Control Supervisor

Quality Control Manager/Site Safety Health Officer

Strategic Clinical Quality Manager - South Carolina Region

Quality Control Inspector Lead

Technical Services Manager

Quality Control Team Lead

Fuels Site Superintendent/Quality Control Manager

Quality Control Shift Manager, 3rd Shift

Construction Quality Control Manager - Healthcare

Quality Technician Team Lead

Dental Lab Manager Technician

Director Quality and Compliance - Hospice

Contractor Quality Assurance/Control Supervisor - Landfill Construction/Cap Construction

Real Estate Listing Agent - High Quality Leads Provided!

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