Director of Quality
1 week ago
Overview:
This position employs an individual skilled in advanced quality assurance techniques with an in-depth understanding of ISO 13485 Quality standard and 21 CFR Part 820 Quality System Regulations. Responsible for leading and influencing Resonetics quality inclusive of product quality, new product introduction and quality management system for multiple Resonetics sites. Areas of focus include but are not limited to:
Statistical process control including implementation and sharing of best practices
Definition and monitoring quality metrics and lead continuous improvement projects
Provide customer management for high visibility or multi-site customers
Lead the corporate supplier management program
Train quality personnel on quality tools and techniques inclusive of GagR&R, SPC, IQ/OQ/PQ Validation Strategy, Root Cause Analysis and Corrective Action, Risk Analysis and pFMEA
This position will focus on improving quality in a contract manufacturing environment. This individual may from time to time directly manage the related activities of specific clients or Resonetics sites as needed.
Additionally, this individual will oversee the maintenance and improvement of the Resonetics ISO certified Quality System and has authority and responsibility to;
Ensure the quality system requirements are effectively established and maintained
Reporting on the performance of the Quality system to management with executive responsibility
Responsibilities:
Oversee the corporate supplier quality management program in alignment with business objectives and regulatory requirements.
Collaborate with the Supply Chain department to manage the Approved Supplier List, including procedures for supplier qualification and ongoing evaluation.
Oversee supplier performance through the analysis of quality data and implementation of continuous improvement initiatives and supplier corrective actions
Work with corporate quality team to establish and maintain the policies necessary to ensure companywide compliance to ISO and government regulations.
Lead and train quality personnel in the tools used for problem solving and root cause analysis
Responsible for leading QA personnel in support of corporate objectives for oversight of quality and improvement. This includes solicitation of respective department input and participation in process development.
Weekly/monthly reporting of activities and chosen performance attributes.
Customer liaison for quality related issues. May assume project manager role for specific customer applications.
Lead multi-site corrective actions and/or continuous improvement projects
Qualifications:
Minimum 7 years experience in a Medical Device Quality Management role.
Lean and/or Six Sigma Green Belt or Black Belt
Demonstrated background in an ISO 13485 and 21 CFR 820 quality management system.
Strong communication skills (verbal and writing)
BS degree in a management or engineering discipline
Experience hosting FDA inspections and ISO audits
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