You manage process validation and documentation while collaborating with suppliers to improve quality. Your role includes leading validation activities and supporting risk management efforts to enhance operational excellence.
Anforderungen
- •Master’s or Bachelor’s in engineering
- •10-12 years experience in Med-Tech
- •Detailed knowledge of medical standards
- •Proven expertise in EU MDR regulations
- •Proven expertise in risk analysis
- •Detailed knowledge of statistical methods
- •Experience in manufacturing electronic products
- •Experience in EUMDR Class III submissions
- •Technical Project Management skills
- •English Level C2 is required
- •Flexible team player with accuracy
- •Excellent analytical and problem-solving skills
- •Proficient in Microsoft applications
- •Risk management activities certification
- •Minimum green belt six sigma certification
- •Previous experience in Abbott’s plants
Deine Aufgaben
- •Plan and execute process validation activities.
- •Create and maintain validation documentation.
- •Lead Test and Inspection Method Validation activities.
- •Support risk management with pFMEA updates.
- •Assist with CAPA and NCMR investigations.
- •Collaborate with suppliers on quality topics.
- •Propose improvements for product quality and efficiency.
- •Drive continuous improvements in operational excellence.
- •Participate in audits as a subject matter expert.
Deine Vorteile
Career development opportunities
Fortune 500 company workplace
Challenging position in industry
Dynamic and motivated team
Multi-national environment
Competitive compensation and benefits
Central location in Zurich
Original Beschreibung
# Senior Technical Specialist
**Switzerland - Zurich** | **Full time**
## JOB DESCRIPTION:
**Senior Technical Specialist (Temporary, start date 1st July 2025- until Dec 2026 - )** to join our team.
Become part of a great team which is responsible for establishing and maintaining processes along the entire supply chain and manufacturing of life-supporting medical devices which are based on the fascinating technology of magnetic levitation. With your work you’ll ensure our products and processes meet the high standards of our industry and are inline with our policy “built as intended for your family”. In your role you will be interfacing and collaborating with cross-functional teams in Switzerland and the USA.
**MAIN RESPONSIBILITIES**
* Accountable for process validation planning and execution including supplier process validations, e.g. Master Validation Planning (MVP/MVR), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Product Performance Qualification (PPQ) and Supplier Process Validation (SPV)
* Creation and maintenance of validation documentation, e.g. validation protocols, validation reports and supporting documentation such as change orders, risk analysis, deviation reports, etc.
* Lead Test and Inspection Method Validation activities (TMV/IMV) Support risk management activities such as process Failure Mode and Effects Analysis updates (pFMEA’s)
* Support CAPA or nonconforming material (NCMR) related investigation or validation activities
* Work closely with suppliers of electronic and mechanical parts on manufacturing and quality topics such as Supplier Corrective and Preventive Actions (SCAR’s) and Supplier Change Requests (SCR’s)
* Propose new or improved technologies and processes to enhance product quality, manufacturing efficiencies, cost, and regulatory compliance
* Drive continuous and measurable improvements OPEX (Operational Excellence)
* Participate in internal and external audits as SME for process validation
**THE PROFILE**
* Master’s degree/bachelor’s in electrical engineering, Mechanical Engineering, Industrial Engineering or similar (ETH/FH or comparable education)
* 10- 12 years or more of experience in a similar position in Med-Tech industry Detailed knowledge of medical standards like ISO 13485, FDA 21CFR820, ISO 14971, IEC 60601-1, MDSAP, GMP, GDP, IMRDF (GHTF)
* Proven expertise in EU MDR regulations and cross-functional department coordination. Leading MDR-related projects will be considered a plus.
* Proven expertise in risk analysis (FMEA), process and test method validation (TMV/IMV, IQ/OQ/PQ)
* Detailed knowledge of statistical methods, techniques, and software tools to analyze data such as Minitab
* Experience in manufacturing of electronic or Electromechanical products is a plus, Knowledge of SAP (ERP system), Windchill (PLM and Change Order system), Solid Works (CAD), Power BI is a plus
* Experience in EUMDR Class III and Class II Medical devices submissions, Obsolescence Management and Various Manufacturing Process (Injection molding) considered a plus
* Technical Project Management: Ability to lead smaller Project independently
* English Level C2 is required
* Flexible team player with accurate working and documentation style
* Excellent analytical and creative problem-solving skills and process thinking
* Proficient in Microsoft applications (PowerPoint, Word, Excel, Visio)
* Risk management activities according to ISO 14971:2019, certification is a plus
* Minimum green belt six sigma certification, black belt is a plus
* Previous experience in other Abbott’s plants will be considered a plus
**The base pay for this position is**
N/A
In specific locations, the pay range may vary from the range posted.
## JOB FAMILY:
Manufacturing
## DIVISION:
HF Heart Failure
## LOCATION:
Switzerland : Technoparkstrass 1 CH 8005
## WORK SHIFT:
Standard
## TRAVEL:
No
## MEDICAL SURVEILLANCE:
Not Applicable
## SIGNIFICANT WORK ACTIVITIES:
Not Applicable