Contract Opportunity - Remote
1 day ago
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 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.
Similar jobs
p>Se busca un enseignant en ligne con disponibilidad los fines de semana. Se ofrece la posibilidad de trabajar desde casa y disfrutar de horarios flexibles. · Flexible schedule · Work from home · ...
1 month ago
Pour travailler au sein d'une équipe dynamique et engagée , nous croyons fermement en la valeur unique que chaque individu apporte, et nous nous engageons à créer un environnement de travail où chaque membre se sent apprécié et respecté. · Extraire les données de ventes des systè ...
2 days ago
We are seeking a highly skilled Mandarin speaking SAP CAR (Customer Activity Repository) Consultant for a client contract. · The ideal candidate will possess 10 years of SAP CAR experience on S4 HANA and IS-Retail. · This is a complex project with innovative solutions and contrib ...
3 weeks ago
+French Language Solutions recrute un stagiaire social media creator pour participer au développement de sa présence sur les réseaux sociaux. · +Création de contenu (photo et vidéo) pour Instagram, TikTok et LinkedIn · Développement du compte TikTok de French Language Solutions · ...
1 month ago
We are hiring a Director, Financial Planning & Analysis - Bilingual to own financial reporting, forecasting and analysis for a growing software business with professional services operations and an international footprint. · ...
1 month ago
We are hiring a Business Development Representative (BDR) to support new client acquisition for our software and marketing platform. · ...
1 month ago
We are seeking an experienced Contract Manager to support our Payments Compliance Program with a strong focus on partner onboarding. · ...
4 weeks ago
Syreon Corporation's Global Team is seeking a SAS Programmer Analyst to collaborate with top-notch researchers in advanced clinical data analytics. · ...
1 month ago
This is a contract-based role for Regional Sales Executive. The Regional Sales Executive will identify and engage with potential healthcare networks and municipal partners, build strong relationships, · drive business growth for Intillum Health's recruitment platform. · Prospecti ...
1 month ago
We are seeking an experienced Contract Manager to support our Payments Compliance Program, with a strong focus on partner onboarding. · Manage the end-to-end contract lifecycle for payments and fintech partners · Support partner onboarding by coordinating contract reviews, approv ...
1 week ago
We are looking for a seasoned SAP ABAP Consultant with 12+ years of hands-on experience and fluency in French to support our global clients across complex SAP landscapes. · ...
1 month ago
Le coordonnateur(trice) bilingue des services aux clients appuiera le directeur des comptes mondiaux à différentes étapes du processus de sélection de sites. · Soutenir activement le directeur des comptes mondiaux ; · Aider à différentes étapes du cycle de vente ; · Aider par la ...
2 weeks ago
We are seeking an experienced Technical Recruiter to manage full-cycle recruitment for IT contract positions across Canada. · Manage the end-to-end recruitment lifecycle, including sourcing, screening, interviewing, offer management, and onboarding for technical roles · ...
3 weeks ago
· The Commercial Contracts Manager will have primary responsibility for the Kinaxis Commercial Legal team in supporting and leading contracting activities between Kinaxis and its vendors, partners, and customers. · This is an existing job vacancy · ...
2 weeks ago
Kaiya Kreatives Marketing is hiring on behalf of a client for a Junior Programmer/Analyst role in application development and maintenance under senior team members' guidance. · ...
1 week ago
Kinaxis is seeking a Commercial Contracts Manager to support and lead contracting activities between Kinaxis and its vendors, partners, and customers. The role will handle diverse contracting matters using strong judgment to keep negotiations and workflows moving efficiently whil ...
3 days ago
We're building something that must be built, and we're the team to do it. Join us in shaping the next frontier of autonomous security. · ...
4 weeks ago
VP / Director – Government & Institutional Business Development - Canada
Only for registered members
This is a revenue-focused business development position responsible for securing funded workforce-development contracts and institutional partnerships. · Secure funded training contracts and revenue-generating workforce partnerships. · Build and own a strong pipeline of RFPs, te ...
2 weeks ago
We are seeking a dynamic and motivated Telemarketer to join our sales team who possesses excellent communication skills, · a persuasive demeanor. · ...
1 month ago
L'activité de GreenFirst Forest Products est ancrée dans la forêt Pour nous, des forêts bien gérées ont vraiment du sens pour notre entreprise nos communautés et l’environnement Nous avons un lien profond avec les terres forestières canadiennes et la durabilité Si cet engagement ...
1 week ago