Validation Consultant

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Validation Consultant / Quality Engineer

Duration: 02/2019 to 02/2020 (negotiable)

Location: Switzerland

Description:

By May 26th 2020, all medical device companies must demonstrate and maintain compliance in accordance with the new EU Medical Device Regulations (EU MDR)

Overall responsibilities:

This role supports manufacturing operations in the areas of process development, tool design, machine programming & layout, machinery & equipment, continuous improvement and other duties associated with engineering support of production.

Position duties & responsibilities:

* Support process validation strategy and writes and executes engineering studies and process validation protocols and summary reports (Installation Qualification, Operation Qualification, Performance Qualification, Computer Software Validation and Test Method Validation).

* Develop and implement control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.

* Develop and implement appropriate process monitoring and control methods consistent with the level of process/product risk.

* Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process limits.

* Ensure the development of a comprehensive risk management plan for the product and process

* Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs

* Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvements

* Assists in the development of manufacturing and inspection procedures.

* Support the Manufacturing Organization in creation, review and release of MPI & Risk Management Activities

* Responsible to originate/oversee/assist in the creation & release of change orders (COs) through Agile PLM software.

* Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.

* Support Base Business and Production Improvement Initiatives

* Additional duties as assigned.

* Know and follow all laws and policies that apply to one's job, and maintain the

* Highest levels of professionalism, ethics and compliance at all times.

Professional experience requirements:

* 4-6 years of experience in quality engineering is required.

* Experience with ISO 9000, ISO 13485 and GMP

* Experience in Design and Process validation

* Quality Tools Knowledge

* Previous experience working in a regulated industry, such as Medical Device is preferred.

* Six Sigma or Lean Sigma certification or 4 years of experience preferred.

* Experience with packaging, Laser, and CNC processes and equipment, preferred

Educational requirements:

* Bachelor of Science Degree from accredited institution in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related degree.

* Demonstrates leadership qualities including confidence, transparency, integrity, innovation, passion, patience and tenacity.

Other requirements:

* Demonstrates strong computer skills, such as the use of Microsoft Office, Minitab, and databases.

* Strong knowledge and skills in PLM system, Agile PLM, SAP, Windchill, Adaptive will enhance candidacy

* Must be highly organized, creative, articulate and analytical

* Demonstrates strong written, verbal and presentation skills.

* Ability to multi-task independently with minimal supervision

Non-technical profile requirements:

* Some flexibility in working hours is required

* Must be able to work on multiple simultaneous tasks with limited supervision

* Quick learner, motivated self-starter

* Excellent customer service, interpersonal, communication and team collaboration skills

* Able to follow change management for internal guidelines

* Language proficiencies:

* English spoken and written

* German conversational is a strong advantage

* Italian is a plus

If you are interested in this or a similiar position please send me your updated CV to my email address: m.tvrdon(at)realstaffing.com

I am looking forward hearing back from you and wishing you a great start into 2019!

Kind Regards,

Marco Tvrdon

Recruitment Consultant

m.tvrdon(a)realstaffing.com

Tel.: +41 (0) 44 588 2640

Sthree Switzerland is acting as an Employment Business in relation to this vacancy.