Top 68 Medical device auditor Jobs

Contract Opportunity - Medical Device Auditors
SGS —Remote
- Contract
- Spanish
- Computer literacy
- English
Quick Apply
7d
GLP Auditor, Part 58, Animal Studies
Pharmatech Associates —Raleigh, NC
- Remote
- 5 years
- Travel
- Senior level
10h
GCP Clinical Auditor II (remote US)
Thermo Fisher Scientific —Texas
- $60,000 - $90,000 a year
- Full-time
- Remote
- Background check
- Up to 50% travel
- Pass drug screening
7d
Associate Director / Auditor, Quality Compliance and Audits
Gilead Sciences —Remote
- $165,495 - $214,170 a year
- Full-time
- Up to 50% travel
- Bachelor of Science
- 8 years
- Health insurance
- Dental insurance
1d
GCP Clinical Auditor III (Remote US)
Thermo Fisher Scientific —Texas
- $75,000 - $115,000 a year
- Full-time
- Remote
- Background check
- Up to 50% travel
- 5 years
7d
Associate Director, Clinical Quality Assurance Auditor
Cytokinetics —Remote
- $195,300 - $227,850 a year
- Full-time
- Remote
- Bachelor's degree
- Travel
- Senior level
Corporate Quality and Clinical Auditor
Hologic —Newark, DE
- $138,000 - $230,000 a year
- Spanish
- 5 years
- Bachelor of Science
Contract Opportunity - Lead Certification Auditor - Pharma, Cosmetics and Personal Care (PCPC)
SGS —Remote
- Contract
- Spanish
- English
- Bachelor's degree
Quick Apply
7d
2nd shift Quality/Compliance Auditor: 4-10's
TOWER LABORATORIES LTD. —Montague, MI
- Full-time
- Microsoft Word
- Bachelor of Science
- Writing skills
Quick Apply
2d
Director, Central Quality Audit, Pharmacovigilance
GE HEALTHCARE —Remote
- $142,400 - $213,600 a year
- 5 years
- Pass drug screening
- English
- Health insurance
- Dental insurance
Auditor II, Global GMP/GDP Audits & Compliance (Candidates local to RTP or Silver Spring ONLY)
United Therapeutics —Research Triangle Park, NC
- $88,000 - $135,000 a year
- Full-time
- Hybrid work
- Microsoft Excel
- Up to 50% travel
- 5 years
- Paid parental leave
- Employee stock purchase plan
Audit Lead
Pfizer —Michigan
- $162,900 - $271,500 a year
- Online Application
- Master's degree
- Supervising experience
- Bachelor's degree
- Paid holidays
- Relocation assistance
Internal Auditor Corporate Quality
Maquet Cardiovascular LLC —Nashua, NH
- $85,000 - $100,000 a year
- Bachelor of Science
- Mid-level
- 3 years
- Commuter assistance
- Disability insurance
Senior IT Internal Auditor
Merit Medical Systems Inc. —South Jordan, UT
- Full-time
- Word processing
- Writing skills
- Ability to lift 50 pounds
- Health savings account
- Paid holidays
Quality Auditor - Radiopharmaceuticals
SQA Services —Chicago, IL
- $4,100 a month
- 5 years
- Writing skills
- Residential
Quick Apply
Staff Auditor II
UPS —Atlanta, GA
- Full-time
- Hybrid work
- Mid-level
- Office
- SQL
Auditor QA
Medline Industries —Illinois
- $79,000 - $119,000 a year
- Full-time
- Remote
- Up to 50% travel
- Writing skills
- Travel
- Health insurance
- 401(k)
Auditor I - Lab
QPS, LLC —Newark, DE
- $45,000 - $50,000 a year
- Full-time
- Laboratory experience
- Bachelor's degree
- US work authorization
- AD&D insurance
- Disability insurance
Quick Apply
7d
Senior Compliance/Audit Manager
Medtronic —Minneapolis, MN
- $145,600 - $218,400 a year
- Full-time
- Engineering
- Office
- 3 years
- Health savings account
- Employee stock purchase plan
Sr Analyst, Financial Operations
MicroVention, Inc. —Aliso Viejo, CA
- $87,329 - $109,120 a year
- 5 years
- Office
- Microsoft Office

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Contract Opportunity - Medical Device Auditors

SGS -
Remote

Quick Apply

Job Details

Contract
7 days ago

Qualifications

Ophthalmology
English
Biomedical regulatory compliance
Technical Proficiency

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

This is a Contract role - must be authorized to travel to and provide auditing services in the United States, Canada and Mexico.

We are looking for Contract Medical Device Auditors with:

Non-active cardiovascular, vascular, and neurovascular implants (2+ years)
Non-active, non-implantable ophthalmologic devices (2+ years)
General non-active non-implantable devices used in healthcare and others non-actives non-implantable devices (2+ years)
Sterilization experts (primarily EtO, Irradiation and Moist Heat, as well as other sterilization technologies)
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
Preferred: experience with ISO 14001, ISO 45001 and/or ISO 50001 based management systems
Preferred: GMP (pharmaceutical, cosmetics, dietary supplements, etc.) quality / regulatory experience

Knowledge/ Skills/ Abilities

Non-active cardiovascular, vascular, and neurovascular implants (MDN1101)
Non-active, non-implantable ophthalmologic devices (MDN1206)
General non-active non-implantable devices used in healthcare and others non-actives non-implantable devices (MDN1214)
Sterilization technologies (primarily EtO, Irradiation and Moist Heat, other technologies are also considered)
ISO 9001 qualification
Strong background and knowledge of technical applications of the standards
Language Skills: Highest advanced level of English, additionally Spanish preferred
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).
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.

Quick Apply

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medical device auditor jobs

Contract Opportunity - Medical Device Auditors

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