Responsibilities:

Responsibility for industrialization and process validation of manufacturing and special processes (end-to-end)
Planning and execution of IQ/OQ/PQ including validation strategy, protocols, evaluation and final reports
Development and moderation of PFMEA including action planning, proof of effectiveness and ongoing maintenance
Establishment of process capability studies (Cp/Cpk), SPC approaches and process windows for critical characteristics (CTQs)
Definition and implementation of control plans, test plans, in-process controls and release criteria
Management of ramp-up activities: line/plant capability, throughput, yield/FPY, bottleneck analysis, stabilization
Interface management with production, quality, R&D, supply chain and external partners (CMOs/suppliers)
Responsibility for process documentation: SOPs, work instructions, parameter lists, traceability, change documentation
Support/leadership of root cause analyses and implementation of corrective/preventive actions (CAPA)
Qualification of equipment and supplier processes (FAT/SAT, acceptance testing, process approvals, outsourcing management)
Ensuring compliance with regulatory requirements (MDR/ISO 13485) during the production transfer, including the design transfer interface.
Experience in dental/implant manufacturing or high-precision manufacturing (e.g., CIM/CNC/grinding/polishing)

Profile Requirements:

Completed technical studies (e.g. process engineering, mechanical engineering, medical technology, production engineering) or equivalent experience
Several years of experience as a Process/Industrialization Engineer in a regulated environment (ideally MedTech)
Demonstrable practice in IQ/OQ/PQ, statistical analysis and auditable documentation
Experience with PFMEA, Control Plan, CTQ methodology and process capability analyses (Cp/Cpk, SPC)
Hands-on mentality on the shop floor, but at the same time strong in documentation and compliance
Structured, independent and goal-oriented work style
Reliability, accuracy and a strong commitment to quality
Excellent communication skills (German & English)

medtechrec is a consultancy specializing in recruitment services exclusively tailored for the ever-evolving medical device industry.

Boasting 13+ years in healthcare and medical device recruitment, medtechrec has a wealth of experience in Contingent, Search and Contract solutions.

We work closely with our clients to understand their goals and challenges, and develop solutions that address their specific needs.

Our dedicated departments focus on:

Commercial

The average Medical Device company is made up of 40% commercial employees.

We source Sales Reps all the way to CCO's.

QA / RA

We spend as much time finding you quality candidates as they will ensuring that your devices meet regulatory standards and safety requirements.

R&D

Engineers, Project Managers, Scientists and Technical Writers.

With a special focus on finding top graduates.

Clinical Affairs

Clinical Trial Managers, Coordinators, Data Managers, CRAs, Medical Writers, Regulatory Affairs Specialists, and Directors and Managers.

Human Resources

HR Managers, Talent Acquisition Specialists and Customer Service staff, to keep your business ticking.

Finance & Strategy

We have a broad network of Finance Professionals with a background in Medical Devices. Understanding M&A and strategy specifically.

Industry

HR & Recruiting

Company Size

1-10 employees

Headquarters

London, GB

Year Founded

Unknown

Website

Social Media