Design Quality Engineering Manager (Onsite)

Cordis•Miami Lakes, FL

3d•Onsite

About The Position

The Design Quality Engineering Manager plans, executes, and manages design quality assurance activities for new product development (NPD) and new business development (NBD), ensuring compliance with regulatory and company requirements. The role provides oversight of Design Quality Engineers, departmental systems, staff development, and personnel performance, while delivering QA leadership and strategic approaches in partnership with cross-functional stakeholders to support efficient development and commercialization. The manager oversees the daily work and priorities of the Design Quality Engineering group, contributes to operating procedures and goals, develops staff, maintains adequate QA procedures and performance, and manages the department budget within established constraints. The role also oversees supervisory responsibilities, communicates business issues and opportunities to management, ensures staff follow Health, Safety, and Environmental practices, and alerts the organization to issues that could affect the business. The position leads effective technical design reviews and the implementation of quality tools in research and development and NPD. It guides engineers in developing and deploying quality engineering tools, techniques, and systems. The manager leads Design Quality Engineers supporting NPD/NBD projects, including design control deliverables, design verification and validation, risk management, labeling, design transfer and launch planning, Design History File verification, supplier quality responsibilities, and applicable NBD supply-chain and launch activities. The role also supports R&D data analysis, post-launch complaints and applicable CAPAs, post-launch design or significant process changes, and relevant external audits. It is responsible for maintaining current knowledge of applicable Design Quality Engineering requirements and for talent management, including recruiting, hiring, termination, performance management, and leadership development.

Requirements

University degree or an equivalent combination of education and experience.
At least 8 years of relevant experience.
Thorough knowledge of the device research and development process.
Knowledge of related national and international regulations and guidance documents.
Knowledge of engineering and scientific terminology and QA practices.
Excellent written and oral communication skills.
Strong attention to detail.

Nice To Haves

Advanced or graduate degree preferred for some disciplines.

Responsibilities

Oversee the day-to-day activities and priorities of the Design Quality Engineering group.
Work with other management personnel to formulate, establish, and update operating procedures and goals.
Hire, train, and develop staff to meet regulatory requirements and follow procedures related to Design Quality Engineering; ensure QA procedures and staff performance are adequate.
Estimate the Design Quality Engineering department budget and maintain operating costs within budget constraints.
Carry out supervisory responsibilities in accordance with organizational policies and applicable laws.
Communicate business-related issues or opportunities to the next management level.
Ensure subordinates follow company Health, Safety, and Environmental practices and have the resources needed to do so.
Alert the organization to issues in time to address potential business impacts.
Ensure effective technical design reviews and effective implementation and use of quality tools in research and development and new product development.
Guide high-level engineers in developing and deploying quality engineering tools, techniques, and systems to support product development and business results.
Lead Design Quality Engineers supporting NPD/NBD projects, including review and approval of design characterization, design planning, design inputs and outputs, verification and validation, operational and performance qualification, risk management, labeling, competitive testing, design transfer, launch planning, and Design History File verification.
Oversee new-product supplier quality engineering responsibilities, including Supplier Quality Agreements and supplied-item/process qualifications.
Lead Design Quality Engineers supporting applicable NBD activities, including Supplier Quality Agreements, determining applicable design-control deliverables, supply-chain and launch planning, finished-device qualification, and direct-ship strategy.
Lead data-analysis support for applicable R&D projects.
Support complaints, escalations, or applicable CAPAs for recent project launches before phase 6 closure.
Support applicable post-launch design and significant process-change projects.
Support external audits involving design control, product risk management, and recent project launches, as applicable.
Acquire and maintain current knowledge of applicable Design Quality Engineering requirements and trends.
Manage talent for the organization, including recruiting, hiring, termination, performance management, and leadership development.