Current Job Openings
PTS Advance is seeking to hire a Quality Engineer to join one of our medical device clients who is a recognized leader in the design, development, and manufacturing of advanced drug delivery devices. This position is fully onsite at my client's fantastic facility in the greater Fort Lauderdale, FL area.
As the Quality Engineer, you will hold responsibility for the effectiveness and quality of product design and process developments ensuring its compliance with applicable regulations. You will also support risk management activities and ensure products are of the highest quality, along with directing product development decisions by promoting a Risk-Based approach. This position is directly involved in the establishment and application of efficient design controls and risk management procedures and tools and actively cooperates with multiple departments.
Main Responsibilities
- Represent Global Quality Engineering in all Design Controls and Product Development related aspects
- Ensure the efficiency of Design Controls (Quality by Design) in projects
- Promote Advanced Product Quality Planning and ensure compliance with relevant standards
- Actively take part in/facilitate Product Development and Quality Planning processes improvement efforts
- Apply Quality Engineering principles in a dynamic way to development and production projects
- Utilize Quality Engineering best practices, ensuring internal and external customers' needs and requirements are built into new products and future product changes
- Support SMEs in the identification and traceability of CTQs
- Support studies performed on simulations, designs, manufacturing processes and a review of engineering experiments (DOEs) utilizing the results to make decisions affecting product and process development direction.
- Lead and execute key design & development related risk management engineering activities to support new product development - from inception through manufacturing, product launch and scale-up - and on-market products for a broad range of product lines.
- Build and maintain Risk Management Files for assigned device projects and platforms consistent with Customer Requirements and compliant to regulatory requirements, including MDR 2017/745, 21 CFR Part 820, ISO 13485, ISO 11608 and ISO 14971.
- Establish and maintain consistent requirement, risk management, and testing traceability for the timely completion of new product launches and design changes for on-market medical device products.
- Maintain and continuously improve the Risk Management process, supporting practices, tools, methods and procedures.
- Support internal and external regulatory audits and inspections, including third party audits of product design history files and technical files.
Required Qualifications
- A degree in science or engineering discipline
- Hands-on experience in product development from ideation to launch in the Medical Device industry,
- Experience in establishing processes, procedure writing
- Knowledge of ISO 13485 and QSR, ISO 14971, IEC62366, IEC62304
- Knowledge and proven application of Quality Methodologies i.e., DFSS, DMAIC, Lean
- Customer orientation and the ability to identify and effectively manage stakeholder expectations
- Ability to cooperate in a cross-functional, inter-company and international environment
- Consensus-building skills to negotiate project deliverables, project risks and priorities
If you or someone you know may be interested, please send your resume to Lisa.Oster@PTSadvance.com or visit us at jobs.PTSadvance.com to learn more about the role. #LifeSciences #PTSAdvancejobs #PTSAdvance
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