We are on the hunt for a Metrology & QC Leader who who is available to take on a new role in an international Medical Device CMO who are expanding their operations in the Czech Republic. The main purpose of the role will be to establish and sustain an effective and standardized metrology operation and organization for the Site. To provide oversight to ensure that all activities in metrology laboratory and quality control areas are performed in a safe and compliant manner with focus on regulatory compliance. To ensure facility objectives are met and actively participate in continual improvement projects.
Main Leadership responsibilities will be:
- Plan for/ implement an effective site metrology/QC strategy through standardization of processes, development of capacity models, organizational design and capability development and implementation of metrology standards
- Provide leadership to support the growth and development of the site Metrology organization
- Manage a team of at least 4 direct reports
- Ensure that effective communication mechanisms are implemented and maintained to enable the execution of day-to-day metrology/QC activities aligned to both Operational and Pre-Production needs
- Identifies and leads continual improvements efforts within the metrology/QC area(s).
- Responsible for building the team, including optimizing the department capabilities in accordance with (internal) customer needs.
- Translates company goals into department goals and execute appraisal cycle
- Work together with the pre-production and production department peers to develop and execute (mid-term) strategies and process improvement
- Drive results and advocate ownership
As well as the above, you will also be responsible for the following QARA activities:
- Deliver on metrology deliverables in support of Production and Pre-Production programs on the tactical and operational level
- Proactively identify requirements to ensure all metrology resources are planned according to demand and that lab utilization is optimized through identifying capacity constraints prior to backlog developing
- Generate, review and authorize Metrology/Quality related documents
- Investigate deviations/Out of specifications, non-conformances and customer complaints by determining the root cause and implementing CAPA actions.
- Analyze data concerning production, processes and the quality management system and propose improvements.
- Ensure correct state of equipment (maintenance, replacement, investments and CAPEX handling);
- Coordinate Validation related Documents
- Quality representative
- Active cooperation and QA work for new customers (new project implementation)
- Responsible for site pFMEA
The successful candidate will Participate and support customer visits, programs, and audits. Develop an appropriate external supplier network who can support the requirements of the site plant maintaining an effective working relationship with suppliers.
Candidates wishing to apply should have the following:
- Bachelor Level (preferred) in Engineering or a technical field or equivalent experience
- Proven management and leadership capabilities.
- Current Good Manufacturing Practices (cGMP)
- Quality Management Systems (ISO13485. FDA 21CFR820)
- Project Management experience
- At least 5 years professional experience
- Experience in Leading a Team
- Experience in Regulatory and Customer focused organization
- Experience in a Pharmaceutical and/or Medical Devices company
- Experience with manufacturing processes like Injection Moulding would be considered as a strong bonus