Company Type
Manufacturer
Location
Amityville, New York
Job Description
• Must have prior medical device experience.
• Coordinate the cross-functional interaction with the Operations and business support teams and oversees the day-to-day quality control, assurance and engineering related to new product development and existing medical RF and Laser product lines.
• Quality assurance program oversight to assure compliance with all applicable regulatory agencies including the FDA/QSR and ISO-13485.
• Implement and enforce current, new, and revised company policies and procedures.
• Guide the organization to leverage company quality systems in a practical manner to assure that current and future products meet the highest quality, safety and regulatory standards.
• Work with the Operations Team to lead and drive continuous improvement.
• Maintain and develop procedural documentation necessary to demonstrate compliance with applicable international standards.
• Work with management and cross-functional teams to create, document, analyze, and improve company processes striving for increased efficiency, effectiveness and reduced costs.
• Provide training on quality requirements for all functional groups.
• Interface with Notified Bodies and outside consultants as the management representative during internal and external QMS audits.
• Participate with process engineering and continuous improvement efforts.
• Expert identification of root causes of problems with ability for swift coordination of appropriate responses, including graphical analysis and Pareto charts.
• Evaluate trends and report Quality Metrics by analyzing warranty returns, customer complaints, non-conformances (NCR’s), scrap, on-time delivery, first pass yields, internal audits and other quality indicators.
• Lead Advanced Quality Planning activity and participate in design control and other activities in support of manufacturing and new product development.
• Manage CAPAs (Corrective and Preventative Actions) and Customer Complaints.
• Advisory and leadership roles supporting various activities; such as raw material, incoming, in-process and final inspection, equipment maintenance and calibration, etc.
• Manage, mentor and develop direct reports.
• Work with operations and engineering to manage, select, develop and approve suppliers.
• Coordinate training of policies and procedures, maintain training records and the documentation control system.
• Work with outside regulatory and QSR consultants as may be required.
• Prepare monthly quality reports.
• Establish and champion “World Class” quality processes and training methods so that all permeate the organization.
Job Skills
• Bachelor of Science Degree in a science-related field required.
• 15+ years of technical professional Quality Assurance experience having at least 10 years in the medical device industry.
• Intimate familiarity with the elements of the Body of Knowledge and Code of Ethics identified by the American Society for Quality (ASQ), as demonstrated by ASQ certification or by demonstrable knowledge and skills in a position as a Quality or Compliance Engineer/Manager.
• Formal FDA/QSR, CE, QMS training, leadership, education and experience in an ISO-13485 certified manufacturing environment.
• Must possess training and strong experience in process mapping, process design, procedure development and document maintenance and control.
• Ability to facilitate QMS development across multiple functions.
• Formal ISO Lead Auditor training and experience, preferred.
• Experienced in Lean Six Sigma, preferred.
• CE Mark preparatory experience and MDD (Medical Device Directive) knowledge, preferred.
• Proven track record of making good business decisions with a practical approach, as well as being a team player.
Job ID: 7167
