Quality Assurance Engineer

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The Judge Group, Inc.
Quality, Engineer, Engineers, Systems, Risk Management, Mechanical, Engineering, System, Analysis, QA
Full Time

Job Description

Location: Leesburg, VA
Salary: Competitive
Description: Our client is currently seeking a Quality Assurance Engineer

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 company's 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 company's 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:

Bachelor's 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

Description/Comment:

Work closely with operations and the business functions to ensure quality performance of product and processes. Collaborates with Divisional QA, cross-functional and suppliers teams to address top quality issues. Applies statistical methods of analysis and process control to current operations in support of management review, CAPA, and other quality system processes. Serves as the GQO Quality representative on Global, Compliance, and product development teams. Develop understanding of risk management practices and concepts and applies knowledge to manufacturing operations. Creation and/or review of new or modified procedures. Provides leadership and subject matter expertise in GQO Quality activities specific to labels and IFUs. Prepare and Review Engineering Change Orders for Regulatory compliance associated with labeling/IFU changes. Up to 10% travel required.

Additional Job Details: Specific responsibilities to oversee the activities needed to complete product-labeling/IFU changes in support of global compliance requirements. High level of detailed accuracy is required. Excellent verbal, written and interpersonal communication skills. Excellent problem solving and analytical skills. Excellent technical writing skills. Requires project management skills and ability to influence without authority. Ability to multi-task and work independently as well as collaborate with teams. Ability to read and interpret engineering drawings and other technical specifications. Background knowledge of EU MDR is a plus.

Contact:

This job and many more are available through The Judge Group. Find us on the web at www.judge.com


Company Information

Judge is the 12th largest IT staffing firm serving clients across North America and Asia Pacific. Our clients include over 50 of the Fortune 100, fast-growing mid-market companies and some of the most innovative tech startups. We are experts at building high performing business-technology teams that lead digital transformations and technology modernization initiatives that help companies drive change. Every company has unique challenges and goals, and Judge invests in each client relationship to understand and deliver customized solutions that exceed expectations.

Dice Id : cxjudgpa
Position Id : 671562
Originally Posted : 2 months ago

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