Quality Systems Lead Auditor

Presentation

We are now looking for candidates with experience working as Quality Auditor in the medical device/pharmaceutical industry!

Our customer is a growing diagnostic company in Stockholm and the assignment is expected to start in February.

Please send in your application today as we will interview and present candidates continuously.

Search words: Quality specialist, Quality Auditor, IVD, ISO 13485


Arbetsuppgifter

As Quality Systems Lead Auditor you will works with management and cross site/functional auditing teams, through the internal audit program, to verify compliance to internal Quality Policies and Standard Operating Procedures, and external regulatory and customer requirements. You will work with quality regulations and standards for medical device industry, both US and international. As Quality Systems Lead Auditor you may also support external and supplier audits and support the QS department in other areas/projects, as needed.

Responsibilities:
- Working in collaboration with management and the internal audit team to schedule, plan, perform, and document periodic internal audits of processes. This includes e.g.; Development and maintenance of the internal audit schedule, Pre Audit planning and preparations, conducting internal audits, writing internal audit reports, conducting follow-up audits when necessary, Creating and maintaining audit records, Tracking, facilitating and reporting audit findings, assisting in preparing management for reporting on the performance of the Internal Audit program
- Supporting other QS department tasks/projects as needed


Utbildning/erfarenhet

The right candidate has a B.S. in Life Science or Engineering, or equivalent and a minimum of 5 years of experience as a Quality Auditor in the medical device/pharmaceutical industry. We also require following skills/experience:
- CQA or ISO Lead Auditor certification is highly preferred
- Strong understanding of IVDD, CFR, and ISO regulations and current industry practice with emphasis in Medical Device manufacturing.
o ISO 13485:2003 Medical Devices – Quality Management System
o US FDA CFR21Part820 (QSR)
o 98/79/EC Directive, In Vitro Diagnostics
o ISO 14971:2012 Medical Devices – Application of Risk Management to Medical Devices
o US FDA CFR21Part11 Guidance for Industry: Electronic Records; Electronic Signatures
o International Conference on Harmonization (ICH) guidelines
- Strong proficiency with Word, Excel and PowerPoint
- Fluent in both Swedish and English, oral and written.

To be successful in this role you possess strong organizational and communication skills. You are hands-on and a team player that are able to communicate effectively with all levels of the organization. Further this role requires that you are motivated to work independently as well as in a cross-functional team environment.



Förmåner

We take good care of our consultants and we offer social activities, as well as help in planning your future career. Your consultant manager is well experienced from your field, and knows how to get the most out of your assignment.

As a Poolia employee, you are included in the requirements concerning agreements on terms of employment by Unionen. Moreover, you get a grant for working out at your choice of place. You are also covered by a health insurance.

Företagsbeskrivning

Poolia Life Science can offer several opportunities for skilled people with a background in biochemistry, chemical engineering or science. We work with Sweden’s leading pharmaceutical and life science companies. So whether you’re interested in research, regulatory affairs, quality assurance, environmental and quality control, sales and marketing, or just want a career change, we have the job for you.

Working as a consultant suits whoever wants to get a lot of experience in a short period of time. We offer you the chance to work with well-known brands at renowned companies where you can develop your skills. If you’re looking for a world of exciting assignments and new contacts, you’ll like being a consultant.

Sluttext

Please apply by registering your CV here on our website. Click on the "Ansök" button to the right. It is our recommendation that you register as much information as possible and that you attach a complete CV-document. Please check that your correct e-mail address is registered.

Poolia is a registered staffing agency, meaning that we comply with the requirements set by Bemanningsföretagen - the Swedish Association of Staffing Agencies.

Language

en-GB