quality engineer/validation consultant-senior à Zug

Lucie Nasshan, Bâle Professionals Health Care & Life Sciences
type d'emploi
postuler >

job details

zug, zoug
Life Sciences
type d'emploi
lucie nasshan, bâle professionals health care & life sciences
058 201 55 50
postuler >

description du poste

Randstad Professionals is currently looking for an Quality Engineer/Validation consultant Senior who will be assigned an interesting challenge for a major client based in the Solothurn area. This contract is an unique opportunity to join a major client, global group focusing on the Healthcare sector (Medical device, Pharma/vaccines, Consumer health).

The initial assignment will start immediately and will last until September 2019.

Job description:

This EU MDR Supplier Quality Supervisor will ensure all product technical file contributions meet new EU MDR requirements. Provide updated contributions to each workstream supporting aspects of the technical file. Reference EU MDR Workstreams for Key deliverables. EU MDR SQ Contract Supervisor will work under the direction of the EU MDR SQ Program Leader.

Your key responsibilities will include

  • Develop project goals, deliverables and plans for execution in 2019 inclusive of the following Workstreams: Packaging & Labeling / Direct Part Marking / Quality Management Systems / Purchase for Resale / MPI Working Group (Manufacturing Process Development) (MDD) / Biological Safety Requirements / Tech File Remediation (PFMEA, PRM, MPI)

  • Support update of applicable Supplier Quality Procedures and Work Instructions.

  • Build, recruit, and manage a Supplier Quality team to meet all workstream objectives.

  • Manage SQ resources to bring Technical Files into compliance with new EU Medical Device Regulations (EU MDR, formerly known as MDD) and re-registering medical devices in the EU (Tech File input consolidation/coordination (PFMEA, PRM, MPI) with workstream inputs.

  • Manage schedule adherence for SQ plans across workstreams.

  • Work with Suppliers to meet EU MDR requirements and resolve issues with obtaining Supplier Product information.

  • Cross coordinate Workstream activities/interdependencies with other Workstream Leads.

  • Partner with Supply Chain to support EU MDR supplier communications and rollout of EU MDR Supply Chain Workstream activities;

  • Partner with EU MDR Supply Chain Workstream Core Team to support tracking and expediting of supplier related product codes to meet project deadlines

  • Support definition and clarification of EU MDR supplier related process requirements.

  • Support Review and Approval EU MDR Change Projects as applicable.

  • Support Supplier Quality Functional Impact Assessments as applicable.

  • Support Review and Approval of supplier Process Validation Protocols and Reports as applicable.

  • Support the update of supplier related Inspection Criteria as applicable.

  • Other related tasks may be assigned at the discretion of local Supplier Quality Management and/or the EU MDR Supply Chain Workstream Core Team (SQ Lead). 

The following skils and experience is required:

  • A minimum of a Bachelor’s degree or equivalent in Engineering and/or Technical Field is required.

  • A minimum of 3 years’ experience in a supervisory capacity is required.

  • A minimum of 2+ years of experience in a medical device and/or pharmaceutical industry is required.

  • Familiarity with ISO-13485 and FDA QSR is required. Excellent organizational skills and attention to detail is required.

  • Must be able to work independently and prioritize with limited supervision.

  • Strong written and oral communication and interpersonal (listening) skills.

  • Excellent computer, communication, and written skills are required. Proficient in Microsoft Office suite is required.

Those skills would be preferred:

  • Three Years of experience as Project Engineer, Quality Engineer, Project Manager or equivalent role within regulated industry.

  • Background in Supplier Management and Process Validation / Verification.

  • Understanding supplier validation procedures and execution.

  • Strong Project Management skills, must understand the critical path, identify program resources, setup project plan and track execution, establish project structure and governance around critical projects.

  • Strong background in Medical Device Regulatory Compliance/Regulatory Affairs.

  • Experience with GD&T, Inspection Methods, and Drawing Review/Approval.

  • Experience working with suppliers across multiple sites and business centers.

  • Process Excellence Black Belt or Master Black Belt

  • Ability to coach and guide core team on project expectations and track progress across multiple-sites and projects.

  • Ability to act as an SME in critical compliance and business processes.

  • Ability to provide regular updates to Quality leadership at various forums