Top 518 Documentation manager Jobs in Dayton, Oh

Quality and Regulatory Manager
Confidential —Dayton, OH
- $60,000 - $80,000 a year
- Full-time
- Engineering
- Team management
- In-person
- Health insurance
- Dental insurance
Quick Apply
7d
Senior Program Manager (F-15)
Astrion —Wright-Patterson AFB, OH
- Full-time
- Bachelor of Science
- Writing skills
- 11+ years
Quality Manager
Groeneveld-Beka Lubrication Solutions Inc. —Miamisburg, OH
- $84,432.34 - $105,681.95 a year
- Full-time
- High school diploma or GED
- Bachelor's degree
- Mentoring
- Health savings account
- Health insurance
Quick Apply
8d
Architectural AutoCAD Project Manager/Designer
Fisher Group Architects, Inc. —Dayton, OH
- $50,000 - $60,000 a year
- Email
- Mid-level
- Office
- Residential
- Health savings account
- Paid holidays
Quick Apply
Physical Therapist Home Care Case Manager- FT Multiple Locations *sign on bonus*
Fidelity Health Care —Moraine, OH
- $20,000 a year
- Part-time
- CPR Certification
- BLS Certification
- Physical & Rehabilitation Medicine
- Health savings account
- Health insurance
Quick Apply
Project Manager - Building Automation HVAC
Point to Point Systems LLC —Dayton, OH
- Overtime
- Background check
- Mid-level
- Office
- Paid holidays
- Health insurance
Quick Apply
8d
Lead Quality Engineer
Verify —Dayton, OH
- $55 - $60 an hour
- Full-time
- Background check
- Management
- Analysis skills
- Health insurance
- Dental insurance
Quick Apply
Configuration Manager, Senior
Torch Technologies —Kettering, OH
- Email
- Background check
- Doctoral degree
- Master's degree
- Health savings account
- Paid holidays
Construction Project Manager
Eagle Pro Home Solutions LLC —Dayton, OH
- $55,000 - $85,000 a year
- Full-time
- Background check
- Construction site
- Customer service
- Health insurance
- Dental insurance
Quick Apply
11d
Field Project Manager-Fiber Services
CCI Systems, Inc. —Springfield, OH
- Full-time
- Clean driving record
- Up to 50% travel
- Mid-level
- Mileage reimbursement
Quick Apply
Traveling Team Lead
First Call Quality Services —Dayton, OH
- Microsoft Excel
- Microsoft Outlook
- Driver's License
- Mileage reimbursement
Quick Apply
Field Project Manager-Fiber Services
CCI Systems, Inc. —Dayton, OH
- Full-time
- Clean driving record
- Up to 50% travel
- Mid-level
- Mileage reimbursement
Quick Apply
Maintenance Supervisor - Dairy Manufacturing
Meijer —Tipp City, OH
- Full-time
- Microsoft Outlook
- Mid-level
- Bachelor's degree
- Store discount
- Paid parental leave
4d
Quality Manager
Alpla Inc. —Vandalia, OH
- Full-time
- 5 years
- Mid-level
- Bachelor's degree
- Paid holidays
- Disability insurance
Quick Apply
9d
Route Supervisor
Rumpke of ohio —Dayton, OH
- Overtime
- CDL B
- Customer service
- 5 years
- Health insurance
- Dental insurance
Quick Apply
Lead Nuclear Medicine Technologist - Springfield Regional Medical Center
Mercy Health —Springfield, OH
- Management
- Hospital
- BLS Certification
- Health savings account
- Disability insurance
8518 - Store Manager
Lids —Monroe, OH
- $19 - $22 an hour
- Full-time
- Ability to walk for extended periods
- Merchandising
- Mid-level
- AD&D insurance
- Disability insurance
Quick Apply
Assistant Store Manager
Lids —Monroe, OH
- $15 - $17 an hour
- Part-time
- Computer literacy
- Merchandising
- Mid-level
- Employee discount
- Flexible schedule
Quick Apply
Registered Nurse - Utilization Manager
Decypher —Wright-Patterson AFB, OH
- $44.92 an hour
- 8 hour shift
- Bachelor of Science
- Mid-level
- Ability to sit for extended periods
Quick Apply
Manager, Human Resources
Energizer Holdings —Vandalia, OH
- $106,700 - $203,600 a year
- Full-time
- Bachelor of Science
- 3 years
- Analysis skills
Quick Apply

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documentation manager jobs near dayton, oh

Quality and Regulatory Manager

Confidential
Dayton, OH

Quick Apply

Job Details

Full-time
$60,000 - $80,000 a year
7 days ago

Benefits

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

Qualifications

ISO certification process
ISO 9001
FDA regulations

Full Job Description

The Quality & Regulatory Manager will implement and maintain the Quality System for the Company especially regarding the medical division. In compliance with applicable laws and regulations, the Quality & Regulatory Manager will lead the strategic and operational aspects of the Company’s regulatory program. This position will be responsible for the Quality Control and Quality Assurance functions, manage quality department personnel, and ensure compliance to corporate policies, US FDA, ISO standards, and other applicable federal/state agency and international requirements, as appropriate.

This position reports directly to the CEO and is an important part of the Company’s management team.

Essential Duties of this position:

Serve as main regulatory correspondent and strategist with FDA, Notified Body/ISO Registrar, other regulatory agencies, partner companies, and service providers.
Serve as the Quality and Management Representative for the company.
Supervise Quality Department employees through training, coaching, and counseling; communicating job expectations; planning, monitoring, appraising, and reviewing job contributions; planning and reviewing compensation actions; monitor and enforce adherence to policies and procedures to ensure compliance and support the needs of the business.
Ensure compliance with all applicable regulations, standards, systems, procedures and practices (includes Quality System, cGMP, and other regulatory standards as applicable).
Maintain an up-to-date knowledge of applicable federal and local GMP regulations and guidelines. Act as the technical expert for all regulations (FDA, ISO, etc.) ensuring the proper processes, policies and procedures are in place to obtain necessary regulatory approvals and maintain regulatory compliance. Monitor external regulatory developments, identify risks, and communicate potential issues to senior management.
Responsible for Quality Agreements and input for supplier agreements.
Provide direction on development and implementation of training programs for direct reports and other functional groups to assure awareness of all quality system requirements and maintain compliance with all current and future regulations.
Manage controlled documentation creation, approval, modification, and release.
Review validation and test report protocol development, execution, and final report review to assure that quality requirements are established and achieved.
Manage supplier quality including qualifications and requalification.
Generate reports, utilizing statistics, as appropriate, to evaluate trends and to aid management in the identification and resolution of issues and overall quality improvement effort.
Assist customers with quality and regulatory requirements, including technical file documentation from a manufacturing perspective as appropriate.
Ensure all procedures and work instructions associated with complaint handling are compliant with internal and external requirements.
Manage the CAPA system to assure that corrective and preventative actions are appropriately investigated and documented.
Review CAPAs prior to closure to ensure required actions were completed.
Assist in the develop of inspection methods, design gauges and fixtures to improve inspection.

Qualifications:

Bachelors degree in Engineering or related field with experience
Having experience with ISO 9001 certification is a must
Experience with FDA regulation is beneficial
Have worked with ISO 7 cleanroom environment is helpful
A familiarity with plastic molding is helpful

This position reports directly to the CEO and is an important part of the Company’s management team.

Job Type: Full-time

Pay: $60,000.00 - $80,000.00 per year

Benefits:

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

Experience:

ISO 9001: 1 year (Required)

Work Location: In person

Quick Apply

Refine Your Search

documentation manager jobs in dayton, oh

Quality and Regulatory Manager

Senior Program Manager (F-15)

Quality Manager

Architectural AutoCAD Project Manager/Designer

Physical Therapist Home Care Case Manager- FT Multiple Locations sign on bonus

Project Manager - Building Automation HVAC

Lead Quality Engineer

Configuration Manager, Senior

Construction Project Manager

Field Project Manager-Fiber Services

Traveling Team Lead

Field Project Manager-Fiber Services

Maintenance Supervisor - Dairy Manufacturing

Quality Manager

Route Supervisor

Lead Nuclear Medicine Technologist - Springfield Regional Medical Center

8518 - Store Manager

Assistant Store Manager

Registered Nurse - Utilization Manager

Manager, Human Resources

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