Quality Operations Manager
il y a 5 jours
We are a rapidly growing pioneer in the medical device industry, dedicated to improving the lives of patients worldwide.
Our mission is to empower physicians to save lives by developing innovative medical devices that meet the highest standards of quality and safety.
We are proud of our strong values and commitment to excellence, which guide our day-to-day operations and drive our continued success.
Why Work with UsWe offer a dynamic and inclusive work environment that values diversity, respect, and recognition of individual contributions.
Our team is passionate about making a difference, and we are committed to providing a safe and healthy work environment that supports the well-being of our employees.
We are a multicultural community that values open communication, collaboration, and continuous learning.
About the OpportunityWe are seeking a highly skilled and experienced Senior Quality Assurance Manager to join our team at Balt.
As a key member of our quality operations team, you will be responsible for ensuring the highest standards of quality and compliance across our production sites.
You will work closely with our Site Quality Manager, Site Directors/Operations Managers, and other site production and process control specialists to ensure full compliance of site production and process control processes.
Key Responsibilities:
- Develop and implement quality procedures, work instructions, and key process indicators (KPIs) to ensure compliance with regulatory requirements.
- Lead and develop a 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 participate in meetings with other site SMEs to share opportunities for improvement.
- 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 Responsibilities:
- Ensure close monitoring and follow-up on any Non-Conforming Event (NCE) or Corrective Action Preventive Action (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.
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.
- Knowledge 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.
- Knowledge of MDSAP program.
- Advantage to have experience as an internal auditor or Lead Auditor.
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