Supply Chain Compliance Manager
vor 4 Wochen
**Job Purpose**
Compliance of external suppliers (component suppliers, contract manufacturers, service providers, 3rd party product suppliers) and goods/services purchased with Straumann procedures and applicable regulations.
- Execution of the supplier audit program
- Perform audits according to the supplier audit program.
- Manage supplier audit records in order to ensure correct documentation, effective closure, including re-audits and observations handling
- Inform the corporate level on audit results allowing the corporate hierarchy to take preventive action.
- Monitor and follow-up Corrective Action and Preventive Action (CAPA) derived from corporate supplier audits.
- Supplier compliance and Vendor Management
- Define the qualification requirements for external suppliers and support during the qualification process.
- Process changes and requests for new suppliers. Reevaluation of existing suppliers.
- Maintain the Approved Supplier List (ASL): Maintenance of quality related data in Vendor Management module in SAP.
- Supplier performance monitoring including trending, data mining and reporting.
- Quality assurance
- Create, update, maintain and train the incoming product inspection planning and release the quality data packages for Headquarter
- Formal batch/product release based on quality certificates and/or record review for goods delivered from external suppliers (excluding Straumann manufacturing sites) to HQ.
- CAPA processing
- Investigate, Review and Approve in the Exception Management Process
- Assess non-conforming products and decide on their disposition
**Main Tasks and Responsibilities**
- Ensure that an appropriate quality assurance system is established throughout the supply chain in order to support the marketing activities.
- Set up and maintain quality assurance agreements (QAA) with the suppliers
- Identify quality issues and escalate them in an appropriate manner (analytical skills)
- Support Straumann and its subsidiaries and distributors with regards to compliance with distributor obligations.
- Ensure that required regulatory documentation for 3rd party products is available for the distribution chain.
- Maintain and improve processes
- Support other Departments in regard of interpretation of quality assurance requirements
- Communicate new quality assurance requirements and support in implementing these.
- Identify possible improvements in the supplier compliance and QA processes, define and lead the implementation.
- Share best practice realization among the Straumann organization to ensure a more functional business development opportunity.
- Auditing (if qualified): Lead Auditor for Quality System Audits (Supplier, Corporate, Internal).
**Profile**:
**Education**:
- University degree or equivalent in an applicable field (quality, engineering or other relevant scientific discipline). Advanced graduate studies/degrees are an asset.
- Formal qualification / training / certification on medical devices regulations such as ISO13485, Regulation (EU) 745/2017 (MDR), US FDA 21CFR Part 820 and other MDSAP regulations.
**Experience**:
- 3+ years of previous experience within the medical devices/pharmaceutical industry or 5+ years of experience within quality management, preferably at manufacturing site.
- Proven experience of Supplier Management and Purchasing Controls regulatory requirements.
- Proven experience with medical devices, including product design, manufacturing, life cycle management.
- Expert understanding of global medical device regulations and quality requirements as well as industry practice.
- Experience in audit process as auditor or lead auditor. Strong analytical and investigational skills.
- Proven project experience, preferably for process improvement projects (Lean, Six Sigma), are an asset.
Personal Attributes:
- Excellent communication skills, as demonstrated in a multi-cultural and multi-lingual environment. Distinct customer orientation both internally and externally. Team player with open, positive attitude and respect for others
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.
**Employment Type**:Full Time
**Alternative Locations**:Switzerland : Basel
**Travel Percentage**:0 - 10%
**Requisition ID**:8843
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