Supplier Quality Engineer Ii
il y a 4 jours
Changing lives. Building Careers.
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.
Responsibilities
- Provides quality assurance leadership to select contract manufacturing sites and raw material suppliers engaged in the production of Integra products
- Establishes and ensures the Approved Supplier List is up to date
- Establishes timely planning and execution of supplier audits
- Conducts Supplier Audits according to good manufacturing practices, ISO Standards, and applicable regulatory requirements
- Ensures comprehensive measurement systems in place to monitor supplier quality/reliability, and to identify, correct and prevent defects
- Establish and ensure Supplier Quality Agreements are up to date for applicable suppliers engaged in the production of Integra products
- Report on contract manufacturer performance metrics
- Ensure technical support to QC, purchasing and production departments
- Provide Quality Engineering Support to suppliers including audits/assessments, inspection technique support, verification /validation activities, CAPA and change management. FDA CFR part 820 and ISO 13485 regulations/standards will be the focus.
- Addresses Supplier Change Requests in compliance with procedures and regulatory requirements.
- Ensures that activities for validation of outsourced processes/products are performed and documented according to procedures and within the defined timeline.
- Ensures that Supplier Non-conformances are initiated, dispositioned, approved and investigated according to plans and in compliance with procedures and regulatory requirements.
- Escalate supplier quality issues to management as appropriate, develop and propose robust and compliant solutions.
- Participates in and leads continuous improvement projects and initiatives.
- Participates and supports internal and third-party audits / inspections.
- Manages or participates in quality projects as required.
- Provides support with complaint investigations as required.
**Qualifications**:
- Experience working in a Medical Device manufacturing environment is preferred.
- Operations supplier quality experience is preferred
- Minimum 3 years of professional work experience in a GMP and /or ISO regulated industry is required
- Knowledge of Medical device standards and regulations such as ISO13485, 93/42 EEC, 21 CFR part 820
- Auditing background is required
- Lead Auditor certification to ISO 13485:2016 strongly preferred
- Strong communication, teamwork, and organizational skills are essential
- Strong analytical problem solving and root cause analysis skills
- Use of ERP, PLM systems
- Use of Microsoft office tools
- Knowledge of statistical techniques
- Experience or knowledge with the machining processes, injection molding, and/or electro-mechanical components/assembly is preferred
- Willingness to travel as part of duties
- Fluent in French and English
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