Supplier Quality Manager

* Act as role model for safety and quality;
* Ensure continuous improvement of supplier performance;
* Serve as technical leader regarding quality matters for the area of responsibility;
* Lead global SQM best practices, quality systems, and processes;
* Develop policies and procedures, seek to harmonize overlapping or conflicting processes, and identify opportunities for lean processes and documentation;
* Actively participate in audits by the notified body or other authorities;
* Manage approved supplier list;
* Manage supplier nonconformance/CAPA process to ensure timely resolution and effective corrective actions;
* Quality owner for complaint investigation, disposition, resolution, and response for supplies (Raw material and BIFG);
* Implement new quality and regulatory requirements with the supplier;
* Strongly cooperate with other departments (procurement, regulatory, supply chain) to solve strategic issues with suppliers;
* Prepare and negotiate quality agreements with new suppliers and update existing agreements;
* Schedule, plan, and execute supplier audits to monitor supplier qualification;
* Monitor validation processes concerning sterilization and production at suppliers;
* According to requirements create, maintain, procure, negotiate and/or check all required supplier documentation such as quality agreements, current certifications or registrations, assessment reports, and delivery specifications;
* Support and monitor supplier compliance with sustainability targets by ensuring that suppliers comply with our supplier standard and that audit is carried out in “high risk” areas;
* Provide statistical analysis on supplier performance and ensure regular KPI reporting;
* Participate in interdepartmental projects to ensure quality compliance with internal and external requirements;
* Initiate and participate in improvement projects;
* Set-up quality inspection strategy/plans in the system;
* Monitor and support product releases;
* Ensure that products have the required regulatory status;
* Provide quality compliance guidance to 3PLs regarding the handling of returned goods, packaging damages, etc;
* Ensure proper training for quality functions for BIFG inspection related tasks.
* 5+ years experience in quality assurance/quality management preferably at medical device manufacturers, pharmaceutical or automotive companies;
* Experienced and certified (supplier) auditor;
* Prefer knowledge of quality system standards, laws, and regulations such as ISO 13485, ISO 14971, US-FDA QSRs, EU – MDR, GxPs;
* Knowledge of modern tools and application in continuous improvement projects (Six Sigma Green or Black Belt certification);
* Excellent communication and influencing skills;
* Big picture orientation;
* Assertiveness;
* Demonstrated ability to work in a matrixed environment;
* Ability to achieve results through problem-solving, decision making, prioritization, organization, and time management;
* Experience in developing strong and effective interpersonal relationships with a range of external and internal stakeholders;
* Engineering or Life Science related bachelor’s degree;
* Business fluent in English (verbal and written).
* Software knowledge: MS Office, Docu Sign, electronic QMS systems. Knowledge of AI applications in supplier quality management, such as predictive analytics for quality control and automation of routine tasks.
* United Healthcare PPO / Eye Med Vision Insurance / Delta Dental Insurance
* Wellness program provided through Rally
* Healthcare and Dependent Care Flexible Spending Accounts (FSA)
* 401(k) with employer match and annual employer base contribution
* Company paid Basic Life, AD&D, short-term and long-term disability insurance
* Employee Assistance Program
* PTO offering with Paid Holidays
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