Supplier Quality Manager

Essity; Charlotte (NC); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Healthcare and Dependent Care Flexible Spending Accounts (FSA)

401(k) with employer match

Employee Assistance Program

Job summary

A leading global hygiene and health company is seeking a Quality Assurance Leader to oversee supplier performance and quality systems. This role involves technical leadership, continuous improvement of processes, and collaboration with various departments. The ideal candidate has over 5 years of experience in quality management, is an experienced auditor, and possesses a Bachelor's degree in Engineering or Life Sciences. Join us in shaping a healthier future through innovative quality assurance strategies.

Qualifications

• 5+ years experience in quality assurance/quality management, preferably at medical device or pharmaceutical companies.
• Experienced and certified (supplier) auditor.
• Knowledge of quality system standards, laws, and regulations like ISO 13485, ISO 14971.

Responsibilities

• Act as role model for safety and quality.
• Ensure continuous improvement of supplier performance.
• Serve as technical leader regarding quality matters.

Skills

Quality assurance

Communication skills

Problem-solving

Decision making

Interpersonal relationships

Education

Engineering or Life Science related bachelor’s degree

Tools

MS Office

Electronic QMS systems

Job description

* 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, DocuSign, 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 / EyeMed 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* Voluntary benefits to include: critical illness, hospital indemnity, and accident insurance* Employee discounts program* Scholarship program for children of Essity employees.Essity is a leading global hygiene and health company. Our expertise began with the acquisition of the Swedish company Mölnlycke in 1975, through which our roots stretch back to 1849. Today, our sustainable innovations from globally trusted brands, designed for everybody and every body, care for the well-being of 1 billion people in 150 countries every day.Working at Essity is not just a career but a chance to make the world healthier, safer, and more hygienic. We innovate for good to break barriers and contribute to shaping a healthier future. At Essity, we have a people-first approach where every career is as unique as the individual. We empower employees to excel together and reach their full potential through a winning culture driven by a powerful purpose. Our performance-orientated environment motivates employees to think differently and embrace challenges so we can continue improving lives, every day through better hygiene and health. We provide a sustainable work-life based on flexibility for both employees and employers. We are committed to Diversity, Equity, and Inclusion in everything we do. It is the key to our success in creating an inclusive, collaborative, and caring company culture where you can be you with us. Our purpose of Breaking Barriers to Well-being, enables customers and consumers to lead fuller lives at all stages of life.Our leading global brands include TENA and Tork, and other strong brands such as Actimove, Cutimed, JOBST, Knix, Leukoplast, Libero, Libresse, Lotus, Modibodi, Nosotras, Saba, Tempo, TOM Organic and Zewa are sold in 150 countries. I In 2024, Essity had net sales of approximately SEK 146bn (EUR 13bn) and employed 36,000 people. We are headquartered in Stockholm, Sweden and Essity is listed on Nasdaq Stockholm. If you want to join a company where dedication to people is powered by innovation, welcome to Essity!