JobWatch

19 days old

QMS Specialist

Kelly Services
St Louis, MO 63103
Kelly Services Outsourcing & Consulting Group is hiring a REMOTE QMS Specialist for a global device company to Lead Site Quality Management System Transition from EU MDD to EU MDR





**Responsibilities:**




+ Responsible for executing gap assessments of the St. Louis site Quality Management System (QMS) and contribute to the development of policies and procedures that are required to meet the EU MDR requirements.

+ As Subject Matter Expert, participate and interface with teams to address and execute the transition of the QMS from the Medical Device Directive to the Medical Device Regulation

+ Monitor, track and provide updates relative to EU MDR readiness

+ Participate in any compliance activities resulting from the review of technical documentation.





**Education/Experience:**




+ Bachelors in degree in a scientific discipline such as biology, microbiology, chemistry, engineering, or medical technology.




+ Minimum of 5 years Medical Device experience leading teams in Quality Systems, Compliance or Regulatory

+ Firm understanding and prior implementation experience of EU Medical Device Regulations (EU MDR) 2017/145, as well as MDD Directive 93/42/EEC, ISO 13485:2016, ISO 14971:2012, 21CFR820,



**Skills:**




+ Excellent written (Technical Writing) and Verbal communication skills

+ Ability to identify Compliance Risks related to the Quality Management System requirements

+ Ability to translate regulatory requirements into task driven processes and procedures

+ Project Management Skills

+ Understand gap assessments on Quality Management Systems against EU MDR requirements

+ Must be able to write clear, understandable technical documents, i.e. regulatory documentation or scientific presentations.

+ Organized, efficient, process-oriented; high attention to detail

+ Effective interpersonal/communication skills

+ Works well cross-functionally and has the ability to interpret the requirements as well as educate and influence others on those requirements.



**This position comes with enhanced benefits which include:**




+ 50/50 shared healthcare cost (Kelly pays 50% of the monthly premium, employee pays 50%)*

+ Paid holidays

+ Paid sick days and vacation days*



**Perks of being a Kelly employee:**




+ Weekly electronic pay

+ Access to more than 3,000 online training courses though Kelly Learning center

+ Online application system

+ Never an applicant fee



*benefits to be received upon meeting eligibility requirements



**Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume.**








**Why Kelly** **** **?**




The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG ) is one focus within the full array of Kelly Services workforce solutions.


Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.


The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.


**AboutKelly Services** ****




As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .


Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm

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Posted: 2019-11-25 Expires: 2019-12-26

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QMS Specialist

Kelly Services
St Louis, MO 63103

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