Senior Supplier Quality Manager HFX
Senior Supplier Quality Manager HFX
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Job Description
DESCRIPTION OF THE COMPANY
TISSIUM is a missiondriven medical device company founded in 2013 headquartered in Paris with a production facility in Roncq (near Lille) and an office in Boston. We are dedicated to creating a new era of body repair by leveraging our biopolymer platform to develop new innovative solutions in surgery for a positive impact on patients lives.
Our technology is based on research and intellectual property from the laboratories of Professor Robert Langer (MIT) and Professor Jeffrey M. Karp (Brigham and Womens Hospital) who cofounded the company with Christophe Bancel (CEO) and Maria Pereira (Chief Innovation Officer).
We are developing polymers for atraumatic tissue repair in various applications. Today these polymers are used for structureless nerve repair hernia repair and cardiovascular sealing
Since our inception we have raised a total of 170 million euros. Our latest fundraising round which concluded in April 2023 resulted in 50 million euros in additional funding. This infusion of capital provides us with the necessary resources to finance the commercialization of our first products.
Joining TISSIUM means taking part in a human adventure in a stimulating and fastgrowing environment while helping to build a future leader in its field.
RESPONSIBILITIES
The Senior Supplier Quality Manager is responsible for the development implementation and continuous improvement of the Supplier Quality Management System (QMS) to ensure product quality and compliance with standards ISO 13485 and 21 CFR part 820 MDR regulation and regulatory requirements. This role involves crossfunctional collaboration with Product Development engineering Technical Procurement Advance Manufacturing Engineering/Manufacturing Engineer and other departments to drive and support suppliers in their enhancement.
- Develop and maintain a robust supplier quality management system
- Ensure the Selection qualification and periodic monitoring of suppliers service providers (quality agreement Audits Approvals annual performance review... in collaboration with Technical Procurement.
- Lead Supplier Audit program schedule perform part of the Audits at supplier facilities and ensure the followup of actions within the defined deadlines.
- Ensure the processing and followup of Supplier NC Change product quality reviews.
- Lead the Supplier Corrective Action Request (SCAR) process to address nonconformities and prevent recurrence working closely with suppliers to implement corrective actions.
- Coordinate the Supplier Change Notification process to ensure timely communication and evaluation of changes proposed by suppliers assessing potential impact on product quality and regulatory compliance.
- Collaborate with crossfunctional teams to drive continuous improvement initiatives and Support suppliers in their skills enhancement
- Ensure the quality and safety of medical devices subcontracted by Tissium
- Guarantee the release and availability of batches of finished products and/or semifinished products from the supplier.
- Provide guidance and training to internal teams on supplier quality management practices and procedures.
- Conduct regular reviews and assessments of supplier performance metrics to drive datadriven decisionmaking and improvement strategies.
- Ensure compliance with regulatory requirements and industry standards related to supplier quality management.
REPORTING LINE
This job will report to theQuality Director.
YOU WILL LOVE THIS JOB IF
- You have good knowledge of manufacturing processes Control Plan setup statistical technique.
- You have a strong knowledge of regulatory requirements (e.g. 21 CFR part 820 FDA ISO13485 ISOand industry standards related to supplier quality management.
- You have excellent project management skills with the ability to lead crossfunctional teams and drive initiatives to completion.
- You have a strong analytical and problemsolving skills to effectively address supplier quality issues and drive continuous improvement.
- You can make independent decisions.
- You have excellent communication and interpersonal skills to collaborate with internal and external stakeholders.
- You can communicate diplomatically and firmly with suppliers.
BACKGROUND
- Masters degree in engineering Quality Management or related field.
- Minimum of 710years of experience in medical device industry
- Manufacturing quality assurance supplier management in the medical device industry.
- Lead auditor certification is a plus
WHY JOIN US
- Evolve in a pleasant and stimulating environment with a work culture that values acting with urgency a willingness to take risks a desire to learn an ability to challenge norms and a capacity to operate within a dynamic range;
- Scalable career paths: At TISSIUM we invest in the training and professional development of our employees with programs adapted to their needs. We believe in the importance of offering varied learning methods to allow everyone to flourish in their professional project.
- An opportunity to join an ambitious and innovative startup striving to address one of the most persistent medical challenges since the inception of surgical procedures.
- Join a MedTech company that is environmentally and socially committed Environmental Social and Governance (ESG) themes are anchored in our business model and as our business grows we found it to be even more essential for us to strengthen and solidify our ESG strategy and commitments.
- Enjoy many benefits: Worklife balance Possibility of teleworking Attractive overall remuneration Opportunities for internal or geographic mobility 2 sites: Paris Boston and Industrial site: Roncq)
- An international work environment with team members from over 19 different nationalities reflecting TISSIUMs commitment to diversity and its inherent strengths.
HIRING PROCESS
- The journey starts with an interview with Talent Acquisition Manager 30 mins).
- Then a facetoface (virtual) meeting with the Manager of the department you are applying to join 1 hour).
- This will then be followed by a Technical Interview to validate your practical jobrelated skills 1 hour).
- For the very final round you will be invited onsite for a team and culture fit interview 1 hour 30 minutes).
Intrigued Wed love to hear from you! Apply today were standing by for your resume!
We firmly believe that building a company for everyone requires a diverse team. Our organization values diversity and welcomes applications from individuals of all backgrounds. We do not discriminate against employees or applicants based on gender identity or expression sexual orientation race religion age national origin citizenship disability pregnancy status veteran status or any other differences. Our company culture prioritizes human interaction and ensures that every individuals voice is heard making our processes lightweight yet efficient.
Employment Type
Full Time
