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Job #02729

About our client Our client is a privately owned medical device company that is focused on the treatment of vascular disease. The company has an experienced CEO and board, an exciting product candidate and a team that is committed to the highest standards of integrity and to improving the lives of patients and their families. Position Location Vice President of Quality Assurance Northwest, USA Salary Highly competitive package, commensurate with experience Responsibilities 1) Direct all quality systems and activities 2) Develop, implement and maintain technical quality assurance systems and activities 3) Define and specify the implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy and reliability of company products 4) Implement and maintain cGMP compliance and ISO certification 5) Participate in reviewing engineering designs and manufacturing processes to contribute to quality assurance requirements and considerations 6) Manage Quality Assurance Department and all QA functions 7) Provide QA input to the company’s strategic goals in the form of schedules, quality plans and budgets 8) Participate (proactively) in achieving team and company goals 9) Control planning, staffing, budgeting, managing expense priorities along with recommending and implementing changes to methods 10) Interface with Product Development, Manufacturing Engineering, Manufacturing, Regulatory Affairs and Logistics on problem-solving and continuous improvement 11) Oversee the management of quality engineering activities (FMEAs, product and process validations, quality planning, failure analyses, test plans and qualification testing) 12) Monitor management of supplier quality selection and auditing, internal auditing, SPC, inspection planning and implementation (first article, receiving inspection, in-process and final inspections as well as sterilization qualification and validation) 13) Provide strategic support to Engineering, Machine Shop, and Manufacturing 14) Oversee development, implementation and maintenance of QA systems and activities, in accordance with applicable regulatory standards and company objectives 15) Develop, implement and maintain effective systems, processes and procedures for ensuring product quality 16) Ensure supplier quality and compliance 17) Perform periodic reviews of company operating procedures and systems to ISO 9000, FDA QSR and other regulatory requirements to ensure compliance 18) Assist functional supervisors to resolve compliance gaps 19) Work in partnership with manufacturing to drive Lean Manufacturing concepts and product cost improvement 20) Assist product teams in risk analysis, performing FMEA and FTA and other applicable activities 21) Implement and maintain cGMP compliance and ISO certification for the company 22) Ensure the effective use of materials, equipment and personnel in producing quality products at minimum costs 23) Participate in reviewing engineering designs and manufacturing processes to contribute QA requirements and considerations 24) Contribute to design input/output definitions and participate in critical design reviews 25) Select, develop and evaluate personnel to ensure efficient operation of the function 26) Define the company’s quality training needs and oversee the implementation and maintenance of a training system to meet defined needs 27) Manage the development of quality planning throughout the product design and manufacturing process 28) Take final decisions on administrative or operational matters and ensure effective achievement of objectives 29) Work on complex issues where analysis of situations or data requires an in-depth knowledge 30) Participate in corporate development of methods, techniques and evaluation criteria for projects, programs and people 31) Ensure that budgets and schedules meet corporate requirements 32) Perform other duties as assigned Requirements 1) BS in Engineering, Technology, Quality Assurance or equivalent industry experience (MBA or Master’s in Engineering preferred) 2) Minimum 10 years of quality assurance and/or engineering experience in a related manufacturing environment along with FDA QSR and ISO 9000 background 3) 5 years of experience in leading the quality assurance function 4) CQE, CRE, CQA, or RAB certification preferred 5) Experience in high-volume manufacturing of a complex medical device and transitioning a company from low-volume to high-volume production 6) Excellent understanding of FDA Quality System Regulations (Part 820 of Title 21 of the Code of Federal Regulations) 7) Experience in implementing quality management strategies and techniques (TQM, Lean Manufacturing and Six Sigma) 8) Superb print reading skills using ANSI Y14.5 9) In-depth knowledge of conventional machining, CNC machining and general metal fabrication processes 10) Experience in using SPC, DOE and FMEA techniques 11) Ability to solve problems independently and within a team environment 12) Ability to be flexible and adaptable to changing priorities as well as working well with different departments 13) Ability to multi-task and delegate effectively 14) Excellent presentation and interpersonal skills 15) Exceptional leadership and communication (verbal and written) skills 16) Proactive and goal-oriented