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3 days old

Quality Engineer

Kelly Services
Raynham, MA 02767
Every day, Kelly Services connects professionals with opportunities to advance their careers. We currently have an exciting contract opportunity with one of our leading clients!





**Title:** Quality Engineer



**Location:** Raynham, MA



**Duration:** 12 months **Overview**




+ Working in the Design Quality team.

+ Candidate will support efforts to ensure EU MDR compliance.





**Responsibilities**




+ Provide support for review of existing documents, assessing gaps, revising documents, creating design engineering rationales to meet EU MDR requirements.

+ Review and approve design documentation including Verification & Validation rationales, risk documents (design and process), standards evaluations, mechanical test protocols and reports.

+ Support risk management activities including planning, design & clinical risk management DFMEA, production risk management PFMEA, and overall risk summary reporting.

+ Revise, review and approve verification and validation activities as required.

+ Review and approve any required drawing updates, including design impact assessments.

+ Review and approve any labeling updates, including design impact assessments.

+ Deliverables to be quarterly based on assigned files.

+ Apply statistical methods and design/process excellence tools to support design engineering rationales/memos as required.

+ Provide leadership in all areas of the Quality System, including, but not limited to corrective & preventive actions, product complaints, post market surveillance, nonconforming materials, risk management, and audit support functions.

+ Provide leadership in the understanding of medical device regulations to other disciplines.

+ Ability to work in a team setting within Design Quality and cross-functionally is required.

+ Communicate effectively at all levels within Quality, as well as cross functionally with departments such as Product Development, Regulatory, Medical Affairs, Manufacturing, and Marketing.

+ Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.

+ Report task progress and status on a weekly basis.





**Required Qualifications**




+ A minimum of Bachelor's degree in engineering or related technical or scientific discipline.

+ Minimum of 5 years of experience in related field are required.

+ Must have a strong compliance background and experience with Medical Device Regulations.

+ Strong design/quality engineering skills with a proven track record in all aspects of the design control process, including functional/design requirements, design verification/validation, and product risk management are required.

+ Proven track record implementing Quality System improvements to meet compliance and overall business goals.

+ Change control experience (reviewing and approving design engineering change orders through a PLM System).

+ Proficiency utilizing MS Office Suite (Word, Excel, PowerPoint etc.).

+ Excellent problem solving, decision-making, and root cause analysis

+ Strong written and verbal communication skills.

+ Ability to effectively communicate with cross-functional teams and program managers.





**Preferred Qualifications**




+ Working knowledge of Design Controls, GMPs, QSR (21 CFR 820), MDD 93/42/EEC, ISO13485 and ISO14971 quality requirements is preferred.

+ Previous experience in a medical device or a healthcare discipline is preferred.

+ Previous Quality Engineering experience is preferred.

+ Working knowledge of material science and mechanical product knowledge is preferred.

+ Development and/or manufacturing experience is preferred.

+ Blueprint literacy including GD&T is preferred.

+ Knowledge of process and design excellence tools is preferred.





**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. Please contact Taryn Carbone ( taryn.carbone@kellyservices.com ) for immediate consideration.








**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.




**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.

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Posted: 2020-01-15 Expires: 2020-02-15

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Quality Engineer

Kelly Services
Raynham, MA 02767

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