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QA Senior OPS Manager F/H
Il y a 2 mois
About Balt
Our purpose is to improve the lives of 150,000 patients in 2026.
Our story
Balt is a rapidly growing pioneer in an exceptional field. For 45 years, Balt has been leading the way - collaborating with physicians and institutions to develop elegant medical devices. Our products are being used by physicians across the world, and we have 13 offices in 11 countries – and counting.
We introduced one of the first neurovascular intervention devices in 1977 and now offer the world's broadest portfolio of medical devices for stroke. As the premier global neurovascular platform always seeking to expand beyond boundaries, we are now bringing our innovation to the peripheral vascular space.
We are proud of our mission, our people, and the incredible work we accomplish together as we empower physicians to save lives.
Why Join Balt? Join a passionate team, dedicated to making a difference.
Working at Balt means giving meaning to your work Pride is a strong part of our identity.
We are a close-knit team, with strong mission, vision and values that guide our day-to-day.
Recognition of work, respect, and our multicultural community are key aspects of the employee experience and contribute to our continued success.
No matter the country, we take care of you.
Would you like to be part of our story? Don't hesitate, come and join us
About the Opportunity
Reporting to the Site Quality Manager, you will work closely with the Site QA Manager, Site Directors/Operations Managers, the Global QA Manager and other site production and process control specialists to ensure full compliance of site production and process control processes.
You will have overall responsibility for the Balt Extrusion and Emboflu production sites (Montmorency in France and Gland in Switzerland respectively) and the site production and process control processes (i.e. line quality support, engineering, validation, labeling, optimization, NPD and metrology/calibration).
Job responsibilities:
- Develop procedures, work instructions and key process indicators (KPIs)
- Lead and develop the team of quality engineers, defining their objectives and regularly monitoring their performance
- Monitor and address any adverse KPI trends for assigned processes
- Identify opportunities for improvement and simplification of assigned processes
- Actively participates in meetings with other site SMEs to share these opportunities
- Ensure smooth communication and working relationships between site quality engineers and manufacturing engineers
- Work closely with the operational function to improve the local quality management system and meet the site's new strategic needs
- Ensure that site validations are implemented on time and maintained accurately
- Ensure that the site's metrology activity is maintained in compliance with the requirements of applicable standards and procedures
- Regularly monitor and evaluate quality assurance processes through close monitoring of data, and report any negative trends and/or opportunities for improvement to the site management team for appropriate action
Additional duties Specific to SME role:
- Ensure close monitoring and follow up on any NCE/CAPA raised against the assigned process within the site, from initiation to fully documented closure
- Follow up with any unfavorable trend in NCE/CAPA affecting assigned process, owns site NCs and CAPAs when linked to assigned processes
- Ensure training is set up and efficiently implemented on assigned processes across the site
- Coordinate and facilitate implementation of process improvement projects across the site to standardize and simplify it and obtain cost savings working in close cooperation with other site Production and Process control SMEs, the site QA director, the site Director and the Global QS Director
- Support the site QA Director in audits for assigned process, preparing, and acting as follow up to internal and external audits
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues on his/her assigned process
- Set up regular process meetings to identify opportunities
Qualification requirements:
- Graduate in quality, engineering or associated fields required (preferably mechanical)
- Experience in working with medical device manufacturers or other equivalent combination of education and experience, experience to be applicable in production and process controls within a certified Quality Management System
- Fluent in English and French
- Strong organization, written communication, and planning skills. Proven ability to successfully direct people and projects
- Must possess a high degree of organization, coordination and influencing skills and be a self-starter
- Proven ability to formulate Quality Operations facility strategies. Ability to plan, direct, and maintain site-based goals and objective relating to the QMS
- Knoledge of the Medical Devices Directive 93/42/EEC with its transposition into French law, the MDR 2017/45, main Medical Devices standards: ISO 13485, ISO 14971
- Knoledge of MDSAP program
- Advantage to have experience as an internal auditor or Lead Auditor
