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Director of Quality Engineering
SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
Our client is a professional Medical Devices organization, based in Zug Switzerland.
The company is a fast-growing enterprise, with a Zurich based HQ. Their production site, scheduled to open in several months from now, will be based in the Kanton of Zug.
We are seeking a highly motivated individual for the role of Director, Quality Engineering to work in this exciting new area of cancer treatment. This position will report to the Vice President of Quality and Operations. Initially the role will be based in the Zurich HQ of my client, but will move to the Kanton Zug-based manufacturing site once it is ready for staff.
In this role you will develop and manage the Quality Engineering function at the Zug manufacturing site in product manufacturing, analytical testing, and manufacturing facility construction. You will develop and manage the overall strategy for process, method, automation and facility qualification. You will work closely with process development staff to improve the reliability of processes and methods through process and method development and characterization. You will also develop and implement efficient and reproducible quality and operations systems, for clinical operations and commercial launch of our products. You will create and implement a validation system, engineering change control, and Corrective and Preventative Action (CAPA) program. Finally, you will develop and implement risk management strategy and tools.
Develop and implement site validation and qualification system:
- Develop and maintain validation master plans for the site
- Work closely with research and development to create full process and method characterization plans and studies/protocols, oversee execution of studies and completion of summary reports
- Develop and implement procedures regarding life cycle product validation and continuous process improvement
- Co-develop automation SDLC strategy with IT for quality and manufacturing systems, including compliance with CFR 21 Part 820, EU MDD and ISO 13485
- Develop and maintain Engineering Change Control
- Provide services to quality and manufacturing to calculate, analyze and interpret gauge R&R studies, measurement correlation, capability, bias, and linearity using conventional and control chart methods
Champion continuous improvement:
- Provide subject matter expertise in Lean and Six Sigma processes and tools
- Drive use of Lean and Six Sigma tools for CAPA system, process performance and product quality monitoring and control
- Effectively select and apply problem solving and improvement methodologies and models (i.e., benching marking, LEAN, Six Sigma, etc.) for process, service, and product improvements both incrementally and breakthrough innovation
- Recommend appropriate statistical techniques for validation, sampling, and inspection processes
- Work with internal and external manufacturing teams to define, identify, and apply product and process control methods (e.g., quality control plans, critical control points, developing and validating work instructions, etc.)
- Develop and implement procedures regarding application of process and performance capability studies in process improvement (i.e., identify characteristics, specifications & tolerances, develop sampling plans, establish statistical control, process limits, percent defective, capabilities indicators such as Cp, Cpk, Cpm, Cr, Pp and PPk)
Develop and implement Risk Management tools:
- Identify and implement improvements for monitoring and control systems in Quality Systems and QC laboratories
- Implement risk management for deviation and CAPA processes
- Develop and maintain risk profiles
- Provide quality technical expertise and project management for technology transfers.
- Work with the development team to define, interpret, and classify quality characteristics for improved products and processes.
- Establish and maintain Key Performance Metrics on a regular basis to support Quality Objectives.
- At least 10 years in a technical quality assurance, manufacturing, analytical testing or engineering with at least 5-7 years in a related management role
- Bachelors degree in Engineering, Chemistry or biological sciences required. Advanced degree preferred (education or training in (biomedical) engineering a big plus), Auditor certification, Quality Engineer certification preferred
- Experience in medical device field required
- Proficient in drafting and completing highly technical documents and presentations
- Document management systems demonstrated knowledge in areas such as technical document creation, electronic and paper archival and retrieval
- Ability to communicate and work independently with scientific/technical personnel
- Ability to work independently with outside companies to complete complex tasks
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Proficient in MS Word, Excel, Power Point, Visio, Project, statistical software, and other applications
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Ability to work after hours as needed
- Fluent in English language, speaking at least business level German a huge plus
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Matthias Kunkel.