Senior Design Quality Engineer
West Chester West Chester, PA 19382
Job Title: Senior Design Quality Engineer
Location: West Chester, PA - 19382
Duration: 12+ Months
About our Client : Our Client is a leading global professional services company, providing a broad range of services and solutions in strategy, consulting, digital, technology and operations. Combining unmatched experience and specialized skills across more than 40 industries and all business functions – underpinned by the world’s largest delivery network – Our Client works at the intersection of business and technology to help clients improve their performance and create sustainable value for their stakeholders. With approximately 425,000 people serving clients in more than 120 countries, Our Client drives innovation to improve the way the world works and lives
- NPD team member focused on product development and life cycle management activities related to the Client Trauma/CMF business.
- Lead design and development planning activities for new R&D projects.
- Participate in all aspects of the creation and execution of functional/design requirements for new products.
- Conduct formal technical design reviews throughout the phases of the product development process.
- Support and approve design verification/validation activities including mechanical testing, tolerance analyses, design rationales, and surgeon based anatomical labs.
- Apply statistical methods and design excellence tools to design verification and validation activities.
- Support risk management activities including planning, design & clinical risk management, production risk management, and overall risk summary reporting.
- Lead the cascade of critical to quality design features to product quality plans and downstream manufacturing & quality processes.
- Work closely with suppliers on the qualification of new parts and processes supporting product development.
- Improve the design control and risk management processes to better reflect state of the art practices and drive continuous improvement.
- 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.
- Communicate effectively at all levels within Quality, as well as cross functionally with departments such as Research & Development, Regulatory, Manufacturing, Supply Chain, and Marketing.
- Know and follow all laws and policies that apply to one's job, and maintain the highest levels of integrity, ethics and compliance at all times.
- Diligently participate in our compliance program related activities as denoted by your supervisor or our Chief Compliance Officer. Additional duties as assigned.
- A minimum of a Bachelor Degree in Engineering and/or in a Technical Science is required. A Master s degree is a plus.
- A minimum of 7 years related working experience in a GMP and/or ISO regulated industry is required.
- We require strong design/quality engineering skills with a proven track record in all areas of the design control process,
- including functional/design requirements, design verification/validation, and product risk management.
- Previous experience in a medical device or a healthcare discipline is strongly preferred.
- Strong working knowledge of QSR (21 CFR 820) and ISO
- (13485, 14971) quality requirements is strongly preferred.
- Manufacturing drawing literacy including GD&T; is preferred.
- Knowledge of process and design excellence tools is strongly preferred. Certification is a plus.
- You should possess excellent problem solving, decision-making, and root cause analysis skills in addition to interpersonal skills that foster conflict resolution as it relates to technical situations.
- You should have a proven track record implementing Quality System improvements to meet compliance and overall business goals.
- Proficiency with the Microsoft Office Suite is required.
About ASK: ASK Staffing is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Staffing connects people with amazing opportunities
Jeff Kasula @ firstname.lastname@example.org - 415-200-4127