Beschreibung
TätigkeitenbeschreibungFür unseren Kunden in Solothurn (CH) suchen wir einen freiberuflichen
Design Quality Engineer (m/w)
Aufgaben:
- Support design control activities for released medical devices by following the governing design change procedures
- Support product risk management activities
- Support the creation of technical documentation for Technical Files and Design Dossiers
- Provide leadership in the understanindg of medical device regulations to other disciplines
- Communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Regulatory, Manufacturing, and Marketing
- Excel in an environment that embraces teamwork, change, risk-based decision-making and flexibility
- Know and follow all laws and policies that apply to the job, and to maintain the highest levels of professionalism, ethics and compliance at all times
Anforderungen:
- Master's Degree in a Technical or Scientific discipline OR Bachelor's degree in a related field plus a minimum of 2 years experience in a GMP and/or ISO regulated environment.
- Excellent problem-solving, decision-making and interpersonal skills that foster conflict resolution as it relates to technical situations are required
- Quality Engineering/Process Excellence/Lean experience is preferred.
- Experience in conducting Product Risk Management including Process / Design Failure Mode Effects and Analysis is preferred.
- Knowledge of the QSR, Design Controls, and ISO quality requirements is preferred.
- Knowledge of ISO Standards for medical devices is preferred.
- Proficient in writing and speaking in English. Knowledge of German / Swiss-German is a plus.
Projektstart:
- asap
Dauer:
- 30.06.2016 (100%, fulltime vor Ort)
Einsatzort:
- Solothurn (CH)
Haben Sie Interesse? Bitte senden Sie uns Ihr englischsprachiges Profil inklusive einer Angabe zum Stundensatz für Solothurn (CH) in CHF (bitte all-in) an
Wir melden uns in Kürze bei Ihnen zurück.
Vielen Dank!
Fähigkeiten (Must have)
design, qsr, Quality