Fortive Corporation Operations Support Specialist – (1 year fixed-term contract) in Schaffhausen, Switzerland
Here’s where you’ll demonstrate your competencies:
· Organization and support of two manufacturing and two packaging lines of STERRAD Cassettes (medical devices) in compliance with all relevant GMP and safety requirements.
· Investigation lead of production non-conformances and CAPA's.
· Responsible for on-time preparation and update of all manufacturing documents (recipes in SAP systems and SOP’s/ WI’s in EZDoc system).
· Coordination and lead of change controls.
· Track, analyze and prepare production reports and metrics.
· Define, coordinate and manage production projects and improvements (single point of contact) in close collaboration with other departments (AVOR, Planning, Engineering & Maintenance, Quality and Logistic).
· Supports production audit readiness and the back office during 3rd party inspections and audits (e.g. FDA, Notified Body, or Customer Audit).
· Preparation and execution of trainings for production staff.
· Investigation and documentation of complaints.
· Other duties may need to be performed as assigned.
· Exhibits and leads on the “Fortive 9” set of core behaviors: Customer-obsessed, adaptable, delivers results, strategic, leads with FBS (Fortive Business System), innovates for impact, inspires, exhibits courage, and builds extraordinary teams.
Here’s what we’ll need from you:
· Minimum Bachelor’s degree, advanced degree preferred.
· 2+ years of previous experience in medical device, pharmaceutical or other highly regulated industry (of manufacturing, packaging or quality area).
· Very experienced in leading and complete NC’s/ CAPA’s/ Change Controls in close collaboration with other departments.
· Very good communication skills in German and English are required (oral and written).
· Experienced in SAP applications.
· Accountability and excellence in execution.
· Willingness to grow and evolve constantly.
· Excellent coordination skills, high learning agility and open mindset for change.
· Able to gain cooperation of others.
· Very experienced in Microsoft Office programs (PowerPoint, Excel, Word, OneNote and Outlook).
· Willingness of on-call (standby) duty is required.
· LEAN and KAIZEN skills required, Six Sigma Process Excellence Green or Black Belt Certification preferred.
Here are a few examples of the traits we value:
· Keen problem solving skills, with a fondness for providing solutions or paths to resolution on complex matters.
· Integrity and excellent judgment.
Excellent organizational skills, exceptional subject matter expertise, a high degree of adaptability and the ability to anticipate and respond to changing priorities.
Solid presentation, communications and influencing skills, demonstrated through all forms of communication.
Ability to drive change and build strong collaborative partnerships across multiple business units, locations, organizational levels, and functions.
Strong time management and document management skills with attention to detail.
· Cultural savvy: the ability to work effectively in a global environment and across numerous legal systems.
· Process and results orientation. A history of building sustainable and innovative standard work and systems.
Fortive is a global family of more than 20 industry-leading industrial growth and technology companies, united by a shared purpose: to make the world stronger, safer, and more effective by providing essential technology for the people who accelerate progress. Here, you get the excitement of a “startup” with the stability and predictability of an organization strongly grounded in its roots and with a proven track record of growth. There’s no limit to what you can learn, or the impact you can make: for you, for us, for growth.
Come join our team at Advanced Sterilization Products (ASP) and be part of a global leader in infection prevention solutions for the healthcare industry. With advanced products, technologies, and workflows for medical sterilization and disinfection, ASP is dedicated to defending the lives of patients, families, healthcare workers, providers, and communities. Add your talent to our extraordinary team and help us in our mission to make healthcare safer for everyone. ASP is based in Irvine, California with core sites in Everett, Washington and Schaffhausen, Switzerland plus many more offices around the world.