7 days old

Quality Assurance Engineer

Kelly Services
Shirley, MA 01464
**Quality Assurance Engineer Shirley, MA**

Kelly Services is currently seeking **Quality Assurance Engineer** for one of our top clients in **Shirley, MA.**

**JOB TITLE: Quality Assurance Engineer**

**INDUSTRY:** Medical Device

**WORK LOCATION:** Shirley, MA

**DURATION:** 6 Months (Temporary / Contract)


Assure product design history files meet the regulatory requirements of Medical Device Regulation, internal quality system and other applicable regulations.

Serve as primary quality representative on one or more EU MDR project teams. Ensure risk management documentation is updated in coordination with activities, and interfacing with project team members including engineering, regulatory, marketing, change management, post market surveillance, and production.

Collaborate with Divisional QA, cross-functional and supplier teams to address quality issues and close gaps.

Approve quality records with the Arena PLM system

Produce technical reports to support product changes or quality assurance investigations.

Prepare, evaluate and critique technical documentation including design justifications and rationales based on sound scientific or engineering principles.

Make decisions and propose solutions based on calculated risks identified through data analysis.

Evaluate procedures and processes within the quality system to identify gaps

Bachelors degree required; degree in Engineering discipline preferred; Biomedical, Process, or Mechanical Engineering recommended.

Minimum of 3 years experience in a quality role for a medical device company; this requirement may be satisfied through equivalent experience obtained from any technical role within a regulated manufacturing environment

Professional certification in a quality subject matter (e.g., MS, CQE, CRE, Six Sigma) highly desirable

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel objects, tools, or controls.

The employee frequently is required to stand, walk, sit, reach with hands and arms, and talk or hear.

Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.

Excellent verbal, written and interpersonal communication skills

Excellent problem solving and analytical skills

Excellent technical writing skills

**Additional Job Details:**

This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree or an extensive amount of practical knowledge gained through experience. Job requires an understanding and application of procedures and concepts of own discipline. The job requires the ability to make judgements based on practice and previous experience. This job typically requires a degree or equivalent and no experience.



**Why Kelly?**

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

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*

**Let us help advance your career today.**

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

As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.

**About Kelly** ****

At **Kelly** , were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

Posted: 2020-11-20 Expires: 2020-12-21

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Quality Assurance Engineer

Kelly Services
Shirley, MA 01464

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