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Job #02692

About our client Our client is a rapidly growing company headquartered in Honolulu that is focused on tissue generation for people with illness. The company has an experienced management team and an empowering corporate culture that is focused on the professional development of its employees. Position Location Director of Quality Assurance Honolulu, HI Salary Highly competitive package, commensurate with experience Responsibilities 1) Establish, implement and maintain formal processes and procedures for the company’s quality system 2) Work with individuals designated with the task and authority for various quality system processes and procedures to ensure effectiveness and compliance of those processes and procedures 3) Assist functional heads of departments and designers in establishing Standard Operating Procedures and work instructions 4) Preside over the Management Review Meeting for quality 5) Administer and oversee Corrective and Preventative Action Program 6) Ensure compliance with activities in the company and at contract facilities related to FDA and EU-Notified Body inspections, governmental actions and follow-up activities 7) Plan and implement quality system processes and procedures for a compliant in-house manufacturing facility 8) Identify, lead and champion programs to improve quality, productivity, cost and customer satisfaction 9) Hire, train and direct managers, supervisors and other quality personnel (Document Control Administrator, Release Coordinator, Compliant Co-coordinator, Quality engineers and QC personnel) 10) Establish the Supplier Quality Program for effective control of major contractors and suppliers 11) Participate actively in the development of business and departmental plans to support corporate goals and objectives Requirements 1) College degree in Math, Life Sciences or Engineering (Graduate-level degree preferred) 2) ASQ Quality Manager, Quality Auditor or Quality Engineer certification preferred 3) Minimum 5 years of experience in a medical device or related quality system environment 4) 5+ years of experience in implementing and maintaining 21 CFR 820 and ISO 13485:2003 compliant quality systems 5) Demonstrated competence in technical areas of quality assurance (statistical analysis, statistical design of experiments, sampling plans, quality auditing, etc.) 6) Proven leadership and creative ability to design and implement quality systems within a medical device organization 7) Demonstrated leadership skills to manage technical groups 8) Ability to mentor employees in the application of statistics, statistical process control, design of experiments and reliability engineering