ACIST Medical Systems is the market leader in providing innovative diagnostic and therapeutic products and services that enable interventionalists and their clinical teams in providing superior patient care. Our focus is “the pursuit of the perfect image” through continuous research and development of new products and technologies – supporting today’s needs and anticipate those of tomorrow. We are an international company, with products in over 45 countries, providing high quality systems and award-winning customer support across the globe.
We believe employees are our greatest asset. ACIST fosters an environment that attracts and retains employees who are proactive, responsive and innovative through commitment to teamwork, communication, feedback and change.
Work collaboratively throughout the organization to promote best-in-class quality of commercialized products, ensuring product performance and reliability while minimizing waste. Ensure product and processes meet or exceed defined performance and customer requirements as well as applicable quality system requirements and external standards. Utilize best practices and continuous improvement principles wherever possible. Lead operational quality business development strategy and execution in the areas of material receipt and QC, in-house manufacturing, contract manufacturing and supplier quality management.
The scope of activity includes in-house manufacturing, contract manufacturing and supplier quality management.
Primary Duties and Responsibilities:
Quality Engineering Management
Provide leadership with strategic insight, directing and implementing all quality engineering activities related to the existing commercialized product and product improvement, in alignment with the ACIST corporation vision of device portfolio management
Take ownership of all aspects of commercialized product quality, using sound judgment to make important and difficult decisions that may involve science and engineering, business risk management, and knowledge of healthcare and product-use environment, using all available sources of internal and external information including customer product experience
Drive continuous improvement of product quality and reduction of waste
Oversee manufacturing quality operations, including subcontracted processes, internal production, and test processes / release
Participate and in some cases lead forums related to quality metrics, cost of quality, master validation plans, QC inspection / release, nonconforming material, complaint investigations, process FMEA and change control
Supplier Quality Management
Establish and maintain a supplier quality management process that ensures product reliability and performance while reducing waste and controlling costs
Participate with head of operations to establish strategic supplier plans and objectives, making decisions on supplier quality matters and ensuring quality operations’ effective achievement of objectives
Manage continuously the supply chain performance of component providers to ACIST production facilities and participate on the supplier review board
Report to senior management on all quality aspects of supply chain management from supplier evaluation and performance to finished goods testing and release, in a manner that drives continuous product improvement
Responsible for management of incoming inspection process, nonconforming material process, and final product release
Qualifications (Knowledge, Skills & Abilities):
B.S. degree in Engineering or other science discipline
12+ years product quality and supplier quality experience in the medical device industry or in combination with other highly-regulated environments
5 years management experience of engineers or other technical staff
Demonstrated success in the coaching, development and overall leadership of a committed, well-aligned team that delivers results
Excellent interpersonal and communication skills to organize and negotiate with multi-disciplinary teams and with different levels of personnel
Thorough knowledge of process validation, statistical method and analysis, and risk management
Innovative thinker and problem solver; brings a big-picture perspective – the ability to see how all the pieces fit together and contribute to the achievement of broader organizational objectives; strong business acumen and judgment
Moderate or strong knowledge in at least several areas pertaining to controlled environments, packaging, sterilization, cleanliness/wash processes, plastics such as molding, extrusion and bonding, and electromechanical devices with embedded software/firmware
Strong technical knowledge and problem solving skills
Travel requirements are moderate. Travel to facilities would be about 2 – 3 days duration each trip with total travel expected to be less than 20%
Ability to develop clear, concise, and timely oral and written reports
Six Sigma or Operational Excellence knowledge or certification.
Demonstrated project management skills in order to plan, conduct and implement system assessments.
Direct experience with regulatory auditors such as ISO and FDA
Demonstrated knowledge of business processes and interactions with executive management
ACIST® Medical Systems is a global medical device company that develops advanced contrast injection technologies that help simplify the...