Custom Search - Logo

Sr. R&D Quality Engineer

Twitter Facebook
Job Type
Direct Hire
Dec 12, 2018
Job ID

Our growing, mid-sized medical device client is adding a Sr. Quality Engineer to their team.  The Sr. QE will be part of the Quality Assurance and Regulatory Affairs group and is responsible for developing, maintaining and improving the quality system in accordance with quality system requirements, domestic and international quality and regulatory standards for all applicable jurisdictions. The focus of this Sr. QE role will be focused on new product development, risk management and reliability expertise. The incumbent will also be involved in other aspects supporting the entire quality management system up to and including complaint and CAPA management, system gap analysis, and participation in internal and external audits or inspections.

Your role with the company:

  • Assist cross functional groups in quality assurance activities and coordinate assigned projects in conjunction with project teams including new product develop and product improvement initiatives
  • Provide support and guidance to cross functional teams to counsel them on quality requirements
  • As a critical resource for new product development programs, apply rigorous reliability design principles alongside cross functional team for new product development programs
  • Function as a risk management liaison
  • Identify sources of quality gaps and design corrective action programs
  • Plan, implement, and coordinate studies for quality process improvements
  • Routinely review QMS and recommend / implement improvements as needed
  • Report on the performance of the quality system and prepare and participate in quarterly management reviews with senior leadership.
  • Assist in the development and/or update of procedures, instructions and methods for inspection, testing, validation./verification, evaluation, recording and reporting quality data
  • Assist in managing and conducting internal and external audits to assess compliance with all jurisdictions and regulatory bodies:
    • European MDD 93/42/EEC and EU MDR
    • Canadian Medical Device Regulations (SOR/98-282)
    • MDSAP (Medical Device Single Audit Program)
    • ISO 13485
    • Japanese QMS Ordinance (MHLW MO 169)
    • Australian Therapeutic Goods (Medical Devices) Regulations (TG(MD)R Sch3)
    • US FDA Quality System Regulation, MDR, Recall
    • CFDA (China) Quality System regulations
  • Coordinate QA activities for design development and change requests including documentation review/approval and provide design inputs related to the quality during the design and development phase
  • Coordinate product release activities
  • Maintain tool calibration and tool maintenance logs
  • Provide support to customer related processes including complaints and medical device reporting
  • Assist in maintenance of quality metrics reporting system and periodic trend reports as part of quarterly management review process
  • Participates as a member of the Material Review Board and compile meeting minutes, reports results and manages the disposition of discrepant materials
Desired Profile:
  • B.S. or M.S. in Engineering or equivalent discipline
  • Minimum of 7 years experience preferably in FDA or ISO regulated environment
  • Minimum of 5 years experience in the medical device industry in a quality / engineering role. Experience with durable medical equipment highly preferred. 
  • Certified quality engineer preferred. ASQ, CRE or other applicable certifications highly desired
  • Experience in nonconforming material/component assessment and disposition, CAPA investigations, technical writing
  • Experience with production quality controls, and Engineering change Order process (ECO)
  • Proficient in incorporating risk management into all activities, minimizing opportunities for errors.
  • Able to independently manage projects and project teams.
  • Experience in application of statistical methods and data analytics to design reliability and process capability
  • Working knowledge of statistical analysis/software experience preferred
  • Effective verbal and written technical communication, analytical, and interpersonal skills
  • Able to independently provide technical solutions to a wide range of difficult problems. Solutions are imaginative, thorough, and practicable, and consistent with organizational objectives.
  • Able to work cross-functionally and contribute as an effective team player
  • Must be able to handle multiple tasks/projects and manage priorities accordingly.
  • Practical approach to quality and a partnering style with colleagues in all functions of the business
  • Optimistic approach to challenges – “can do” style
  • Ability to understand and take Direction well and to expand concepts into executable plan.