Director, Design Quality

Director, Design Quality

Stryker

Cork, Ireland

The Director, Design Quality will be responsible for guiding, directing and managing the quality engineering team responsible for providing quality support for Product Development and Product Life Cycle Management, focusing on design controls, including new product development and ongoing product support. The Director will provide strategic direction and guidance for design controls and changes to existing products ensuring compliance to regulations. The position requires high level management and insight into development projects to ensure time-to-market and technology objectives are met while ensuring that the Quality Management System requirements are adhered to.

Job Details:

  • Establish strategic vision and direction for the Design Quality Group;
  • Provide expertise and support for development projects from project inception through successful Technology Transfer/Scale-Up at the manufacturing facility;
  • Oversee all Quality Support for the PLCM program, leading quality initiatives and identifying/managing continuous improvement projects with the objective of achieving quality and cost improvements;
  • Ensure project plans adequately address design, validation and Quality departmental requirements and standards, ensuring tasks are executed compliantly;
  • Management and documentation of Design Control activities through post launch review;
  • Develop and implement appropriate risk management strategies and programs;
  • Develop plans for integration of new products, transfers and mergers;
  • Develop quality engineering function capable of providing guidance and tools for product development and problem solving using appropriate tools (Six Sigma, SPC, DMAIC);
  • Interpret industry and government regulations and be creative in application of these regulations to practically implement to optimize compliance and business processes;
  • Maintain current knowledge of global medical device regulations pertaining to Quality Systems, assist in facilitation of internal and third-party audits as needed;
  • Prepare, communicate, and evaluate team goals and objectives for continual improvement of the efficiency and effectiveness of the quality system along with providing individuals with professional growth;
  • Translates overall vision and values to team; establishes mid- to long-term objectives to align with company vision and accomplish organizational goals;
  • Determines and implements best strategic direction for the function with regard to organization, competencies, human and fiscal resource planning, quality planning and Design Control best practices;
  • Leads a department of less experienced professionals including performance management, goals and objective setting, and personal development planning;
  • Assures short term training needs for staff are addressed, and longer-term individual and organizational development needs are identified, planned, and implemented;
  • Manages external resources, including consultants;
  • Perform other job-related duties as required.

Education/work experience:

  • BS in a science, engineering or related Advanced degree preferred;
  • MS, PhD, CQE or CRE desired;
  • Six Sigma Green or Black belt preferred;
  • Minimum of 15 years’ experience in a manufacturing and product development environment preferred;
  • Master's Degree or equivalent preferred;
  • Six Sigma experience, CQE/CQM/PE certification preferred.

Knowledge/competencies:

  • Prefer experience with medical device product development lifecycle, including risk management and design/process verification and validation;
  • Knowledge of national and international regulations applicable to medical devices including Quality System Regulations, 21 CFR 820, ISO 14971, ISO 13485, and MDD 93/42/EEC, EUMDR;
  • Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poke Yoke;
  • Demonstrated ability to read and interpret CAD drawings;
  • Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required;
  • Thorough knowledge and understanding of US and International Medical Device Regulations;
  • Strong knowledge of Quality Concepts (e.g. CAPA, Audits, Statistics);
  • Must possess strong project management skills as well as have the ability to manage multiple tasks simultaneously;
  • Demonstrated ability to advocate for product excellence and quality;
  • Strong interpersonal skills, written, oral communication and negotiations skills;
  • Strong in critical thinking and "outside the box" thinking;
  • Highly developed problem-solving skills. Strong analytical skills;
  • Demonstrated ability to successfully manage and complete projects in a matrix organization;
  • Demonstrated ability to manage a multi-discipline, multi-technology, team-based organization and assume responsibility of quality, regulatory, and compliance targets;
  • Experience with recruiting, people development;
  • Influence across the organization;
  • Some travel may be required.

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© EuroJobsites 2022

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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