Top 263 Iso 13485 lead auditor Jobs

Senior Quality Manager
EDISON WELDING INSTITUTE INC —Columbus, OH
- Full-time
- Bachelor of Science
- Engineering
- 3 years
Quick Apply
Quality Manager - Bemis Health Care
Bemis Manufacturing Company —Sheboygan Falls, WI
- Writing skills
- Engineering
- 3 years
Quick Apply
Electronics Quality Engineer - PCBA
Electronic Source Company (ESC) —Van Nuys, CA
- $90,000 - $110,000 a year
- Full-time
- PMP
- Computer literacy
- Engineering
- Health savings account
- Health insurance
Quick Apply
Service Quality Engineer Lead
Hologic —Newark, DE
- $120,100 - $188,000 a year
- Full-time
- Bachelor of Science
- Analysis skills
- Senior level
Production/Manufacturing Quality Engineer
VM Services, Inc. (member of the Venture Group of Companies) —Milpitas, CA
- $85,000 - $100,000 a year
- Full-time
- Microsoft Excel
- Microsoft Access
- 5 years
- Health insurance
- Dental insurance
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Supplier Quality Engineer
SMC Ltd. —Santa Rosa, CA
- $86,000 - $103,000 a year
- Full-time
- Microsoft Excel
- Microsoft Outlook
- PMP
- Paid holidays
- Disability insurance
Quick Apply
Sr Supplier Quality Engineer
Weil Group, Inc —Juncos, PR
- Temporary
- Bilingual
- Background check
- Mid-level
Quick Apply
Auditor, Lead
American Bureau of Shipping (ABS) —Houston, TX
- $100,000 - $115,000 a year
- Full-time
- Up to 50% travel
- Customer service
- Mid-level
IMS Consultant
Omnex —Ann Arbor, MI
- $600 a day
- Email
- Mid-level
- 3 years
- Training & development
Quality Auditor - Pharmaceutical/Medical Device
SQA Services —Chicago, IL
- $1,300 a day
- Contract
- 5 years
- Residential
- Travel
Quick Apply
Lead Auditor, Quality Compliance
Integra LifeSciences —Plainsboro, NJ
- $109,250 - $149,500 a year
- Email
- Engineering
- 11+ years
- Master's degree
- Disability insurance
- Health insurance
Senior Auditor, Auditing and Due Diligence
Alvogen, Inc —Morristown, NJ
- $135,000 - $142,000 a year
- Full-time
- Up to 50% travel
- 5 years
- Computer literacy
- Wellness program
- Health savings account
Quick Apply
Regulatory Affairs / Quality Assurance Senior Consultant (Contractor)
MedEnvoy Global BV —Remote
- Contract
- Remote
- 7 years
- Microsoft Excel
- Microsoft Outlook
Quick Apply
5d
Regulatory Lead
Teguar Corporation —Charlotte, NC
- Full-time
- Office
- Product management
- Training & development
- AD&D insurance
- Paid holidays
Quick Apply
Senior Quality Auditor
SYNCARDIA SYSTEMS LLC —Tucson, AZ
- $80,000 - $110,000 a year
- Full-time
- 5 years
- Office
- Mentoring
Quick Apply
Quality Auditor
ResMed —San Diego, CA
- $68,000 - $102,000 a year
- Full-time
- Engineering
- Mid-level
- 3 years
- Commuter assistance
- Health savings account
5d
Post Market Surveillance SME - Medical Device #6887
Enhanced Compliance Inc. —Remote
- Full-time
- 5 years
- Engineering
- Analysis skills
Quality Management System (QMS) Auditor and Compliance Manager
Ichor Systems, Inc. —Austin, TX
- Urgently hiring
- 5 years
- Engineering
- Master's degree
- Employee stock purchase plan
- Paid holidays
Corporate Quality and Clinical Auditor
Hologic —Newark, DE
- $138,000 - $230,000 a year
- Spanish
- 5 years
- Bachelor of Science
GLP/GCP Quality Compliance Auditor
Labcorp —Indianapolis, IN
- Full-time
- Master's degree
- Bachelor's degree
- Mentoring
- Employee stock purchase plan
- Disability insurance

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Senior Quality Manager

EDISON WELDING INSTITUTE INC -
Columbus, OH

Quick Apply

Job Details

Full-time

Qualifications

Stakeholder relationship building
Stakeholder management

Full Job Description

EWI is the leader in materials sciences and the go to experts that many of the country’s largest and most innovative organizations call to assist with their most difficult assignments. Our business success relies on strong execution and continuous improvement – driven by the expertise and teamwork of our employees. We are always searching for exceptional candidates to join the EWI team and be a part of our forward-thinking, innovative, best-in-class organization! We have a rich history in the community and are and are proud to call Columbus our home.

We are seeking a highly experienced and strategic Senior Quality Manager to build and lead our quality function from the ground up. This is a senior leadership role responsible for establishing a robust Quality Management System (QMS) and driving a culture of quality, compliance, and continuous improvement across the organization. The ideal candidate brings deep expertise in regulated environments and a strong background in contract research.

ESSENTIAL FUNCTIONS:

Establish and lead the QMS: Design, implement, and institutionalize a comprehensive Quality Management System from the ground up, ensuring alignment with relevant regulatory standards and business objectives
Define and own all quality policies, procedures, work instructions, and standards across manufacturing and engineering operations
Serve as the organization’s senior quality authority, providing strategic direction and guidance to executive leadership on all quality-related matters
Lead all internal and external audits, including regulatory inspections, and ensure timely and effective resolution of findings
Oversee root cause analysis (RCA) and corrective/preventive action (CAPA) processes across the organization
Build, mentor, and scale a high-performing quality team, including quality engineers, auditors, and inspectors
Partner with contract research organizations (CROs) and external partners to ensure quality standards are met throughout outsourced activities
Manage supplier and vendor quality programs, including qualification, audits, and ongoing performance oversight
Drive continuous improvement initiatives using methodologies such as Lean, Six Sigma, or 8D
Represent the quality function in client-facing interactions, regulatory submissions, and contract negotiations
Monitor and report on quality KPIs, trends, and risks to the executive team and board as required

KNOWLEDGE/SKILLS/ABILITIES:

Demonstrated experience establishing a QMS from inception in a regulated industry
Strong knowledge of quality standards and frameworks (ISO 9001, ICH Q10, GxP, FDA 21 CFR, ISO 13485, AS9100 or equivalent)
Proven experience working within or managing contract research environments, including oversight of CROs and third-party partners
Deep expertise in audit management, CAPA, risk management, and regulatory compliance
Exceptional leadership, communication, and stakeholder management skills
Ability to operate effectively at both the strategic and operational level
Familiarity with ITAR/EAR compliance requirements
Prior experience interfacing directly with regulatory bodies
Proficient in MS Office products (Word, Excel, PowerPoint, etc.)
Excellent verbal and written communication and interpersonal skills
Ability to work well with ever-changing priorities and/or situations
Exhibit and maintain positive, solutions-oriented attitude toward work and co-workers
Excellent organizational skills and ability to work well under stress, despite numerous interruptions
High degree of accuracy and attention to detail in assigned tasks on a consistent basis
Outstanding interpersonal skills and ability to communicate effectively with all levels of associates
Team-oriented attitude and focus with strong ability to collaborate with others

PREFERRED QUALIFICATIONS:

ASQ Certified Quality Manager (CQM), Certified Quality Auditor (CQA), or equivalent
Six Sigma Black Belt or Master Black Belt certification
NADCAP accreditation experience in one or more special processes (e.g., NDT, welding, heat treating, chemical processing)
Familiarity with electronic QMS (eQMS) platforms and data integrity requirements

EDUCATION:

B.S. in Engineering or a related field
Master’s degree or MBA preferred

EXPERIENCE:

Ten (10) or more years of progressive quality management experience
Three (3) years in a senior or director-level role
Experience with government contracts
Experience in a manufacturing or contract research environment is desirable

EXPORT CONTROLS - This position requires access to information and technology that is subject to U.S. export controls. To conform to U.S. export control regulations, applicant should be eligible for any required authorizations from the U.S. Government.

EOE/M/F/Disability/Protected Veteran Status

Accommodation:

Individuals who need reasonable accommodations under the ADA in order to participate in the search and/or application process should contact Human Resources at (614) 688-5000.

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Refine Your Search

iso 13485 lead auditor jobs

Senior Quality Manager

Quality Manager - Bemis Health Care

Electronics Quality Engineer - PCBA

Service Quality Engineer Lead

Production/Manufacturing Quality Engineer

Supplier Quality Engineer

Sr Supplier Quality Engineer

Auditor, Lead

IMS Consultant

Quality Auditor - Pharmaceutical/Medical Device

Lead Auditor, Quality Compliance

Senior Auditor, Auditing and Due Diligence

Regulatory Affairs / Quality Assurance Senior Consultant (Contractor)

Regulatory Lead

Senior Quality Auditor

Quality Auditor

Post Market Surveillance SME - Medical Device #6887

Quality Management System (QMS) Auditor and Compliance Manager

Corporate Quality and Clinical Auditor

GLP/GCP Quality Compliance Auditor

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