Director, Design Quality Assurance, Diagnostics Information Solutions (DIS)-Med Device

Location: Santa Clara, CA
Date Posted: 02-11-2018
The Director, Design Quality Assurance, Diagnostics Information Solutions (DIS) will be a strong partner to the Global Quality and Regulatory function, as well as across the various DIS sites and functions.
  • Responsible for managing the Design Quality Assurance function and interfacing with local Operations (including Clinical Operations), Quality Management and Development to assure all products and processes are developed in accordance with company standards and quality systems.  This is accomplished through Strategic Quality Planning, Quality System execution and maintenance, non-conformance, corrective and preventive action reporting and follow-up, quality audits, performance metrics and continuous improvement projects.
  • Determines and implements best strategic direction for local site Design Quality Assurance with regard to organization, competencies, human and fiscal resource planning, quality planning and Design Quality Assurance best practices. Coordinates Design Quality Assurance activities in support of Manufacturing Operations and associated Development activities.
  • Coaches the Design Quality Assurance staff in activities including but not limited to: support of the Product Lifecycle Management process, Design Controls, Design Changes, CAPA and Nonconformance resolution, Quality Plan and Quality Agreement generation, Verification and Validation activities, and Clinical Quality oversight.
  • Develops Design Quality management processes to enable the latest methodologies for the software development (Agile), deployment (Cloud), and DevOps processes.
  • Works with external regulatory agencies to define and implement the latest quality management standards applicable to Software as a Medical Device (SaMD) and Clinical Decision Support software (CDS).
  • Participates in cross-functional meetings/initiatives and sets and maintains the standards for interdepartmental actions and the integration of quality planning with development and operations planning.
  • Performs administrative functions including performance management, goals and objective setting and personal development planning. Assures short term training needs for local staff are addressed, and longer term individual and organizational development needs are identified, planned, and implemented.
  • Bachelors’ degree in Biological Sciences, Business Administration or related field, or equivalent combination of education and work experience.
  • Master’s degree/PhD, or equivalent preferred.  ASQ Certified Quality Manager (CQM), Engineer (CQE), Auditor (CQA) preferred.
  • 10+ years minimum (12+ preferred) of relevant medical diagnostic/device industry experience, including experience focused on design controls, product lifecycle, quality systems, regulatory affairs/compliance, project management, controlled documentation, product labeling, and/or change control.
  • Thorough working knowledge of relevant international IVDD, MDDS, SAMD, ISO Standards (13485, 14971) and regulations (European medical devices directives, 21 CFR - part 820).
  • Direct experience defining, documenting and implementing new Quality Management Systems and associated product development process deliverables for RUO and regulated software product development using Agile methodologies.
  • Enthusiasm for the role that Quality and Regulatory (Q&R) can play in enabling the development of new products for our patients by contributing in a startup environment
  • Drive to engage positively with Q&R/Business teams and make impactful contributions in a multi-cultural/national environment
  • Track record of providing sound Q&R judgment/ideas and business partnering

Very competitive salary and benefits!
Great company to work for!
Full relocation package is available!
Don't miss out! Apply now and we'll be in touch immediately with more specific details, salary information and to answer any questions!!

This position does NOT provide sponsorship so please do NOT apply if you require sponsorship.  Thank You

KP Recruiting Group 
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