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Quality Engineer II

Kelly Services

Raynham, MA
Job Code:
  • Engineering
Kelly Services
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Job Details

Job Title Quality Engineer II

Jobid US41ALEF_BH1437150

Location: Raynham, MA, 02767, USA

Description **Quality Engineer**

Kelly Services is currently seeking a Quality Engineer for one of our top clients in Raynham, MA.

+ The Customer Quality Engineer works collaboratively with Quality, Manufacturing, Product Development and other functional experts.
+ We are counting on you to be knowledgeable regarding regulations and standards affecting Medical Devices e.g. ISO9001/13485/14971/14001, FDA Regulations 21CFR 803, 806, 820, part 11, etc. CMDR, and Medical Devices Directive 93/42/eec, 98/79/EC .

+ Serves as a liaison between the quality assurance department and other departments for complaint investigations; Interfaces with key business partners including research and development, regulatory and compliance, operations, service and repair, medical affairs, medical safety, post market surveillance and international affiliates as required
+ Utilizes statistical tools and appropriate investigative techniques to analyze complaint root cause and corrective actions
+ Ensures complaint investigations are robust and well documented Files MDR Medical Device
+ Reporting and MDV Medical Device Vigilance reports as necessary to health authorities
+ Escalates events in a timely manner and per procedure;
+ Ensures key department metrics such as complaint closure and health authority reporting timeliness are met
+ Prepares responses to customer inquiries regarding complaint investigations and prepares trend reports for complaints.
+ Summarizes the results of various data analysis into clear and concise presentations and reports for peers, cross-functional teams and management
+ Supports such activities as post market surveillance, complaint reports and safety signal detection
+ Supports process improvement activities and the CAPA process as necessary
+ Supports any Internal and External Audits as necessary Knows and follows all laws and policies that apply to one’s job, and maintain the highest levels of professionalism, ethics and compliance at all times All other duties as assigned

+ Minimum of Bachelor s Degree is required, preferably in an Engineering, Life Science, or related discipline.
+ An advanced degree is a plus.
+ Minimum of 2 years of direct or related experience in a regulatory environment is required.
+ Excellent problem solving, critical thinking, and decision making skills is required.
+ Ability to conduct root cause analysis is required.
+ Ability to prioritize and multi task.
**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States.

**Why Kelly?**

+ As a Kelly Services employee, you will have access to numerous perks, including:
+ Exposure to a variety of career opportunities as a result of our expansive network of client companies
+ Career guides, information and tools to help you successfully position yourself throughout every stage of your career
+ Access to more than 3,000 online training courses through our Kelly Learning Center
+ Weekly pay and service bonus plans
+ Group-rate insurance options available immediately upon hire*
**Apply Today!**

_*Available for purchase and administered by a designated third-party vendor_

**Why Kelly** **®** **?**

Kelly puts you in charge of your career, with access to cutting edge projects and technologies inindustry leading organizations. Top companies throughout the world have trusted Kelly as a premiersource of engineering talent and services since 1965. And engineering job seekers know Kelly as a firmwith an unmatched reputation for quality, integrity and professionalism. Whether you seek the varietyand flexibility of working on short term project engagements, or prefer contract-to-hire or directhire placement with our clients, apply with Kelly to explore opportunities that suit your specificprofessional interests.

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit 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 iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.

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