1+ months

Quality Assurance Engineer

Kelly Services
Leesburg, VA 20178
**Quality Assurance Engineer Leesburg, VA**

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

**JOB TITLE:** **Quality Assurance** **Engineer**

**INDUSTRY:** Medical Device

**WORK LOCATION:** Leesburg, VA

**DURATION:** 12 Months (Temporary / Contract)


**Who Do We Want:**

Self-directed innovators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

Motivated product launchers. People who bring strategic direction and drive for execution to ensure products are developed and launched with precision and quality.

**What Will You Do:**

As the Staff Quality Engineer, NPI you will lead the development and implementation of process improvements, inspection strategies and plans for associated NPI projects. You will take initiative in and make continuous strides towards optimization of inspection methods and sampling. You will also lead and support First Article Inspections.

**Additional Responsibilities include:**

Subject Mater Expert in Design Transfer processes and procedures, participating and interfacing in internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise. Support audit preparation strategy and execution.

Lead and plan Design Transfer file activities from initiation to close out.

Responsible for and ensures the efficient and timely transfer of knowledge to Quality engineering support of the production environment. Coordinate the training of Quality Engineers and related personnel on new quality systems, processes, and equipment as necessary.

Oversight and activist of NC & CAPA related to new products, expert and mentor in problem solving and root causing activities.

Co-ordinate the monitoring and reporting of new products quality metrics to the companys leadership team during Post-Market launch for prescribed period.

In partnership, develop Supplier Quality Systems related to NPI and ensure suppliers ability to deliver new products and components right first time.

Optimize inspection costs while maintaining safety, integrity, and reliability of the product.

Develop & Implement Risk Management Principles. Lead and ensure Risk Management documents are generated, applied to the process to minimize risk to patient or user harm. Ensure all Risk Management outputs comply with ISO14971 for use in Regulatory Submissions.

As a key member of NPI project teams, be accountable for implementing quality systems while achieving product/process performance, quality objectives, project planning and effective execution, as well as communicating program status and escalating issues when appropriate.

Co-ordinate the monitoring and reporting of new products quality metrics to the companys leadership team during Post-Market launch for prescribed period.

Participate in approving various Design Transfer documents including PFMEAs, Control Plans, SOPs and PPAPs associated with new product launches.

Conduct MSA studies for new products and new processes.

Provide training for manufacturing team members.

Ensure adherence to GMP and safety procedures.

Develop, review and approval of validation documentation.

**What You Need:**

Bachelors degree in engineering required. (Mechanical Engineering preferred).

5+ years related work experience required. Candidates with more than 5 years of experience encouraged to apply.

Proficiency in GD&T, highly preferred.

Proficiency in machining or working around machining highly preferred.

Experience working with metals, titanium, stainless steel highly preferred.

Experience with Measurement System Analysis and Gage R&R studies highly preferred.

Previous experience in a regulated environment within an R&D or manufacturing environment required. 2 years experience in new product/process is a distinct advantage.

**Additionally, You Should Have:**

High proficiency in statistical methods and application. Apply appropriate statistical techniques to ensure the development of robust, predictive quality systems which are easily transferable and maintainable in a production environment.

Working knowledge/experience of Risk Based and statistical techniques, in particular process risk, statistical sampling plans, Process Capability, Gauge R&Rs.

Excellent Interpersonal Skills - able to express ideas and collaborate effectively with multidisciplinary teams.

Experience in executing complex problem-solving techniques related to manufacturing/design technical issues. Good instincts and sound judgement for mechanical and structural design.

Good understanding of Design for Manufacturing (DFM), related statistical tools and validation/verification techniques.

Excellent analytical skills, ability to plan, organize and implement concurrent tasks.

Good knowledge of manufacturing processes, materials, product and process design.

Ability to be the voice of Quality when dealing cross functionally

**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: 2020-07-27 Expires: 2020-09-26

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Quality Assurance Engineer

Kelly Services
Leesburg, VA 20178

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