Quality Management System Sr Manager

VaudPermanentChemistry, Pharma, Biotech2019-03-29Bachelor / University of Applied Sciences
Spring Life Sciences is looking for his client a

Quality Management System Sr Manager

Your challenges

  • Develop and lead the quality management system (QMS) in Europe, including certifications, audits, supplier management, distribution centers, document control, training, CAPA, management review; ensures alignment with corporate QMS; drives continuous improvement processes; advises specific in-country needs and remote departments (eg Field Service); support supplier audit and special processes related to sterilization or reprocessing
  • Ensure compliance of the European QMS to applicable QMS regulation, including ISO 13485:2016, EU MDD/MDR, MDSAP and 21 CFR 820
  • Identify QMS gaps and develop solution strategy by implementing and monitoring CAPAs, quality & operational plans, KPIs
  • Promote awareness of applicable QMS and regulatory requirements across the organization
  • Lead complex cross-functional project teams that may be global in nature
  • Advise other departments (sterilization & reprocessing activities, field service, manufacturing, distribution centers, clinical affairs, ...)
  • Act as a central RAQA point between corporate US RAQA and local departments, including remote (Marketing, Sales, Field Service, Clinical Affairs, Sterilization) or local (customer care, HR, contract, IT...) departments
  • Other projects may be assigned as necessary
  • People Management: determine goals and objectives while removing obstacles for the team
  • Travel: up to 20%

Your skills

  • At least 10+ years' experience in medical device industry operating according to US or EU regulation including at least 3 years in medical devices quality system management, quality manufacturing or regulatory affairs
  • A Bachelor degree, Engineering or Master's degree in medical technology, life sciences or similar (or equivalent work experience in similar function)
  • Team management experience of small team size associated with goals objectives definition / people development
  • Deep knowledge of EU MDD 93/42/EEC, EU MDR 2017/745/EU, US FDA CFR 21, ISO 13485:2016
  • Solid understanding of manufacturing operations, change control, and an awareness of regulatory trends
  • Strong interpersonal skills with demonstrated ability to lead projects autonomously and to collaborate effectively with various scientific and business representatives in international team environment
  • Require a highly motivated, resourceful individual who can set goals, work independently and exercise daily judgment based on above regulatory knowledge
  • Demonstrated organizational and planning skills, including action oriented and can-do attitude, focused urgency and driving for results
  • Excellent verbal and written communication and presentation skills, ability to distill complexity and provide clear and actionable direction
  • Orientation for work result details, with emphasis on accuracy and completeness
  • Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook)
  • Language: Fluent English and French or German
  • Lead auditor certification for ISO 9001, 13485 and knowledge of WW regulations
  • Good knowledge of medical device reprocessing/sterilization or refurbishment requirements
Project management skills regarding new site implementation / certification

Your contact

Are you interested? Please apply directly online.

The reference of this job ad is JN -032019-295424