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Staff Quality Engineer (Medical Devices R&D)

icon building Company : Jondavidson
icon briefcase Job Type : Full Time
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Job Description - Staff Quality Engineer (Medical Devices R&D)

Performs a wide variety of quality assurance activities in the successful completion of projects or aspects of large programs, and may function in a project leadership role. Supports a variety of engineering work in the design, development, and evaluation of medical devices. Applies extensive technical expertise and has full knowledge of advanced statistical techniques. Leads development and successful implementation of quality systems and procedures which will enable R&D to respond rapidly to customer needs. Plays an active role in internal quality audit program. Interacts with senior external personnel on significant technical matters often requiring coordination between organizations. Supports maintenance and expansion of QA/QS and supervisory knowledge in areas applicable to Quality Engineering.

Responsibilities:

  • Support quality initiatives for plant issues.

  • Support cross-functional planning, coordination, and reviews.

  • Ensure compliance with company quality policies, procedures, and practices through appropriate communication, training, and education of sound quality assurance principles.

  • Ensure compliance with all local, state, federal, and company safety regulations, policies, and procedures.


Quality Systems:

  • Assist in the development of quality systems for R&D center in Singapore.

  • Prepare Quality systems documents to ensure compliance with QSR, ISO, and EN requirements.  Track and report system changes.

  • Drive continuous improvement of the Quality System. 

  • Lead compliance to FDA QSR, ISO 9001 and ISO 13485 quality systems requirements with specific focus on design control requirements of the regulations.

  • Lead Situational Analyses and Risk Management Reports for products.

  • Provide QS knowledge to organization as needed. Administer training as appropriate.

  • Provide inputs to Management Review meetings.

  • Act on, and close findings requiring immediate action by the organization on a timely basis.

  • Work closely with Manufacturing to identify root causes and develop, implement corrective action. 

  • Establish system for, and promote, the use of statistics in the testing and control of quality.


Product Development

  • Contribute as a team member on development projects carrying out assigned quality assurance responsibilities in a timely, diligent, safe, and professional manner.

  • Provide expert engineering knowledge in the product development process.

  • Lead the development of quality plans, execute inspection & testing activities and work further with Manufacturing on the transfer of quality requirements.

  • Subject matter expert for information on quality-related product design and development tools.

  • Support implementation of effective and timely transition of design from research to development to manufacturing.

  • Develop and promote advanced understanding of customer needs and processes to ensure relevant and innovative product development.

  • Apply Design to Cost and Design for Manufacturability methods to support project leader in achievement of project objectives.

  • Support R&D in device product/ process development and production activities, including the following:

  • Develop and/ or reviews product/ process verification/ validation or test plans (protocols and reports).

  • Develop and/or reviews product/process specifications and requirements.

  • Develop and/or reviews product reliability specifications/ predictions; reliability test activities.

  • Conduct/ coordinate risk management activities including review failure mode effects analysis (FMEA), hazard analysis, and fault tree analysis (FTA) and/or risk or statistical analysis.

  • Participate in product or process design and change activities, including design reviews.

  • Provide technical support for product quality attributes/ decisions.


Organizational Development

  • Actively mentor associates in related technical roles.  Provide technical direction and frequent feedback. Participate and assist in their success. Continue to raise the bar on technical skills and help associates rise to expectations. Advise management of technical needs and desired skill mix.

  • Establish a high bar for recruiting technical talent. Ensure excellence in technical recruiting.

  • Provide technical support to Unit Business(es). 

  • Contribute to assembly and maintenance the Design History File (DHF).

  • Perform any other tasks as assigned.

  • Travel as required by project scope and timing.


Requirements:

  • Bachelor’s degree in mechanical engineering, biomedical engineering, or related engineering discipline. Good working knowledge of medical device regulations and practices (ISO 13485, FDA QSR, etc.).

  • Complete understanding of quality assurance principles and concepts, total quality tools, continual improvement approaches, industry practices, and standards. Possesses extensive technical expertise and has full knowledge of other related disciplines.

  • Advanced understanding of design control, disciplined product development processes, regulatory, and quality requirements.

  • Advanced knowledge of Six Sigma methodology, statistical methods and analysis.

  • Ability to translate customer needs into design inputs and specifications.

  • Good knowledge and understanding of process development, total quality tools, and continual improvement approaches.

  • Advanced leadership, motivational, and team building skills, with the ability to lead organizational change.

  • Excellent technical writing skills.

  • Strong critical thinking, analytical, and problem solving skills.

  • Demonstrated ability to quickly learn new subject matter.

  • Project Management skills

  • True self-starter with the ability to work towards goals with little day-to-day supervision.

  • Able to identify, break down and solve a variety of difficult design quality problems.

  • Ability to recognize deviations from accepted practice and apply knowledge of Design Control on a daily basis.

  • Ability to prioritize and multi-task many different forms of work input that are both strategic and operational in nature.

  • Disciplined and well-organized in documentation (plans, requirements, drawings, design reviews, and test methods).


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