Director of Quality

5 days ago

Royersford, United States Globus Medical Full time

Position Summary:


Provide leadership in achieving the highest level of manufacturing quality of medical devices and quality system performance while ensuring compliance with all company policies and procedures. Lead and enforce regulatory compliance with US FDA, State, OSHA and international medical device regulations and ISO 13485 quality system requirements.

Responsible for development, implementation, and continual improvement of quality systems and procedures supporting manufacturing operations, supplier management, documentation and records, training, quality management, and auditing.

As a wholly owned subsidiary of Globus Medical, Branch Medical is responsible for state-of-the-art CNC machining and finishing operations associated with orthopedic implants and related medical devices. The Director of Quality will ensure alignment with corporate strategic goals and objectives, foster an environment of team development using coaching and mentoring, lead facility compliance, and implement quality improvement initiatives based on Lean Management and Six Sigma principles and practices.


Essential Functions:


  • Leads the Quality Management System supporting manufacturing process development and operations while ensuring compliance with all regulatory requirements including US FDA, State, OSHA, and international medical device regulations based on ISO 13485 quality system requirements.
  • Provides leadership for business process excellence and foster a culture founded upon Lean Management and Six Sigma principles and practices to drive customer value through continuous improvement.
  • Serves as the business Management Representative to maintain a culture of compliance and excellence.
  • Ensures the integration of risk management and risk analysis based on ISO 14971.
  • Ensures the integration of risk based thinking throughout business processes to support decision-making.
  • Works with the management team to establish strategic goals and objectives, organizational alignment, and a results-oriented work force.
  • Provides leadership for workforce education and development within Quality.
  • Develops, implements, communicates, and maintains quality planning supporting ISO 13485 quality system requirements and annual business goals and objectives.
  • Oversees all Quality functions including documentation and training, customer feedback, nonconformance, CAPAs, supplier quality management, QC Inspection, and final product release.
  • Manages and maintains the Company’s internal quality audit program and assess improvement initiatives resulting from all Quality Audits – internal and external.
  • Ensures individual performance and business process performance meets established goals and objectives.
  • Establishes, follows, and improves company procedures as needed to maintain compliance and meet business goals and objectives.
  • Provides written and oral communication to help ensure an engaged and informed workforce and management team and keep them informed of results.
  • Maintains a cooperative and motivational attitude with co-workers.
  • Performs other tasks as requested by supervisor to meet business goals and objectives.
  • Adheres to all Company policies, rules, procedures and housekeeping standards.
  • Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies.
  • Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role.
  • Represents the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties.


Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.


Qualifications:


  • Requires a bachelor’s degree (Engineering, Science, or Business preferred). A relevant post-graduate degree or qualification would be an advantage, but not essential.
  • Minimum of 5 years of experience leading Quality Assurance / Quality Systems with experience in FDA and CE Notified Body inspections.
  • At least 10 years of progressive experience is needed in QA/QC management in a manufacturing environment, preferably in the medical device industry.
  • Lean and Six Sigma experience with a proven track record of business performance improvement and personnel development.
  • Broad knowledge of manufacturing process control and validation.
  • Knowledge of measurement systems and inspection process management.
  • Understanding of Mil, ISO, and other applicable standards.
  • Exposure to shop environment such as noise, dust, odors and fumes.
  • Direct supervision of quality assurance employees in a manufacturing facility.
  • Experience with manufacturing process quality, process controls plans and validation, CNC machining and finishing operations, and inspections systems is preferred.
  • US FDA cGMP and ISO 13485 knowledge preferred. Manufacturing plant safety. Computer proficiency with MS Office and statistical analysis tools is required. Multi-discipline assurance background is desired with emphasis on problem solving and continuous improvement through work force engagement and development.
  • ASQ certification or equivalent preferred (CMQ/OE, CSSBB, CQE, Lean Six Sigma). Must be able to make solid decisions that effectively support the business and company policies.
  • Travel requirements are as needed.
  • Presentation skills and ability to train personnel in Quality and Regulatory Compliance.


Physical Demands:


The physical demands listed here are representative of those that must be met by and employee to successfully perform the essential functions of this job.

  • Required to sit; climb or balance; and stoop, kneel, crouch or crawl
  • Required to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds
  • Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus

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