Top 61 Medical device auditor Jobs

Contract Opportunity - Medical Device Auditors
SGS —Remote
- Contract
- Computer literacy
- English
- Mid-level
Quick Apply
Assistant Controller
Nuclein —Austin, TX
- Full-time
- CPA
- ERP systems
- Finance
Senior Lead Auditor - Medical Devices
DNV —Houston, TX
- Full-time
- Senior level
- Commuter assistance
- Paid parental leave
Former FDA Investigator (Mock Inspection/Audit Consultant)
RQM+ —Remote
- Senior level
- Communication skills
- Ability to lift 25 pounds
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Associate Director, Clinical Quality Assurance Auditor
Cytokinetics —Remote
- $195,300 - $227,850 a year
- Full-time
- Remote
- Bachelor's degree
- Travel
- Senior level
Quality Auditor - Pharmaceutical/Medical Device
SQA Services —Chicago, IL
- $1,300 a day
- Contract
- 5 years
- Residential
- Travel
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Laboratory Quality Auditor
Applied Medical —Rancho Santa Margarita, CA
- $75,000 - $85,000 a year
- Full-time
- English
- Mid-level
- Bachelor's degree
- Paid holidays
- Tuition reimbursement
Quality Auditor I or II
Sotera Health —Salt Lake City, UT
- Full-time
- Customer service
- Mid-level
- Presentation skills
Senior Quality Auditor
Abbott Laboratories —Lake Forest, IL
- $86,700 - $173,300 a year
- Full-time
- Engineering
- 3 years
- Driver's License
- Health insurance
- Tuition reimbursement
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
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Auditor I
QPS, LLC —Newark, DE
- $45,000 a year
- Full-time
- Bachelor's degree
- US work authorization
- Entry level
- AD&D insurance
- Disability insurance
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Medical Device Audit Inspector
Astura Medical —Irving, TX
- $20 - $21 an hour
- Full-time
- Surgery
- Ability to walk for extended periods
- Computer literacy
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Controller - Medical Device Manufacturing
VISIONQUEST INDUSTRIES INC —Vista, CA
- $125,000 - $140,000 a year
- Full-time
- 7 years
- Oracle
- CPA
Corporate Quality and Clinical Auditor
Hologic —Newark, DE
- $138,000 - $230,000 a year
- Spanish
- 5 years
- Bachelor of Science
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
Staff Accountant I
Regenity —Paramus, NJ
- $70,000 - $80,000 a year
- Full-time
- Mid-level
- Office
- Ability to climb stairs
- Wellness program
- AD&D insurance
Senior Director, Internal Audit & Compliance
Olympus —Westborough, MA
- $144,541 - $216,812 a year
- Full-time
- Remote
- Engineering
- 11+ years
- Analysis skills
- Paid parental leave
- Paid holidays
8d
Quality Auditor I
Sotera Health —Salt Lake City, UT
- Full-time
- Customer service
- Computer literacy
- Bachelor of Science
Senior Quality Auditor
SYNCARDIA SYSTEMS LLC —Tucson, AZ
- $80,000 - $110,000 a year
- Full-time
- 5 years
- Office
- Mentoring
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2nd shift Quality/Compliance Auditor: 4-10's
TOWER LABORATORIES LTD. —Montague, MI
- Full-time
- Microsoft Word
- Writing skills
- English
Quick Apply

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Contract Opportunity - Medical Device Auditors

SGS -
Remote

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Job Details

Contract

Qualifications

Accreditation standards (regulatory compliance area)
Biomedical regulatory compliance

Full Job Description

Company Description

SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 96,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.

Job Description

We are looking for Contract Medical Device Auditors with the following preferred experience:

Non-active cardiovascular, vascular, and neurovascular implants (2+ years)
Non-active, non-implantable ophthalmologic devices (2+ years)
Sterilization experts (EtO, Irradiation, Moist Heat)
ISO 9001 qualification

As a Contract Medical Device Auditor, you will perform third-party audits per SGS Certification procedures and the requirements for standards such as ISO 13485, MDSAP, MDD and MDR. You will be responsible for making relevant decisions concerning the audit process and to inform SGS as required to resolve issues outside the audit process. The Contract Medical Device Auditor is responsible for collecting and analyzing sufficient information to provide a recommendation for certification.

Perform audits for clients’ medical device quality systems and technical information to the requirements of ISO 13485 and other regulatory requirements such as MDSAP, MDD, MDR and EU.
Decide upon evidence gained during audits whether or not registration should be recommended or allowed to continue.
Participate actively in witness audits by SGS or accreditation bodies.
Maintain all audit credentials.
Adheres to internal standards, policies, and procedures

Qualifications

Education and Experience

Bachelor’s degree in a related discipline (i.e., Engineering, Bioscience, Biomedical, Science, etc.) AND
Minimum 4 years of experience working with medical devices under ISO 13485, MDSAP, MDD and/or MDR compliant QMS.
Preferred: Possesses Auditor Credentials for one or more of these standards: ISO 13485, MDSAP, MDD and MDR

Knowledge/ Skills/ Abilities

Preferred Experience with:
Non-active cardiovascular, vascular, and neurovascular implants
Non-active, non-implantable ophthalmologic devices
Sterilization experts (EtO, Irradiation, Moist Heat)
ISO 9001 qualification
Strong background and knowledge of technical applications of the standards
Language Skills: Highest advanced level of English
Excellent communication and interpersonal, verbal, written and presentation skills
Proactive attitude and excellent organizational skills
Effectively reacts in stressful situations and makes clear, well-founded decisions regarding conformity during the audit
Ability to multitask and manage multiple projects while delivering results on time
Act with integrity, tact and character
Computer Skills
MS Office Suite (Word, Excel, PowerPoint) – Intermediate user proficiency

Travel

Travels up to 80% of the time (automobile & airplane).
Must be able to travel to both US and Canada
Weekend travel may be necessary to meet scheduling requirements.

Additional Information

SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required.

This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company’s rights to assign or reassign duties and responsibilities to this job at any time.

If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call 201-508-3149 for assistance and leave a message. You will receive a call back. Please note, this phone number is not for general employment information, but is only for individuals who are experiencing difficulty applying for a position due to a disability.

All your information will be kept confidential according to EEO guidelines.

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Refine Your Search

medical device auditor jobs

Contract Opportunity - Medical Device Auditors

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2nd shift Quality/Compliance Auditor: 4-10's

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