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Skills: Quality Assurance, Device Master Record (DMR), ISO 13485, CFR 820, Supplier Quality Management
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Specialist - Identity and Access Management - 2060
pune, Maharashtra, India · On-site
Senior$6.5B raised
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Full-time
bachelor degree
Health Insurance, Life Insurance, Disability Insurance, 401(k) Contributions, Paid Time Off, Employee Assistance Program
Posted 40d ago
~40 hrs/week
Responsibilities
Responsible for quality assurance of Device Master Record (DMR) procedures and the maintenance of inspection criteria data. Supports supplier change control, vendor evaluations, and the preparation of complaint trending reports to ensure regulatory compliance.
Requirements
Requires a bachelor's degree and 3-5 years of experience, with at least 2 years focused on quality control or supplier quality management. Candidates must have knowledge of ISO 13485 or ISO 9001 and excellent English communication skills.
Full job description
Job Summary
Associate QA specialist is the role who responsible for quality assurance on the procedures of DMR and inspection criteria data maintenance. Implement the actions under supervisor’s supervision to ensure requirements are met under ISO13458 and CFR820.
Job Description
(1)Assist in collecting and verifying Device Master Record (DMR) documents for Medline products in compliance with regulatory requirements and project schedules;
(2)Support drafting inspection criteria for new finished goods, assist in updating and maintaining criteria for existing products on Medline quality management platform (ETQ);
(3)Help keep all inspection criteria on Medline quality management platform (ETQ) fully functional for daily inspection use;
(4)Support document review for supplier change control requests and assist supplier in finishing relevant change procedures;
(5)Participate in new product sample build review and assist supplier in understanding product specifications;
(7)Assist with supplier re-evaluation for vendors due for their periodic review under Vendor Evaluation Procedure and issue corresponding review dispositions;
(8)Review Component Sourcing Form submitted by suppliersand assign Quality Warnings (QW Codes) based on review outcomes;
(9)Collect the COC/COA from suppliers, conduct verification and upload records to the quality system;
(10)Complete ad-hoc tasks and special projects assigned by supervisors and DQA team.
Qualification: (1) Education level: Bachelor degree at least; (2) Working experience: 3-5 years working experience, at least 2 years’ experience on quality control or supplier quality management; (3) Understanding supplier manufacturing process and inspection process; (4) Knowledge on regulation/standards, risk assessment, customer needs, historical adverse events, etc. with inspection criteria; (5) Specific knowledge: Quality system knowledge of ISO13485 or IS09001 is a plus; (6) Certifications: CET-6; (7) Language: excellent verbal and written English.
Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For a more comprehensive list of our benefits please click here. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.
We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging pagehere.
Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.
Medline is the largest provider of medical-surgical products and supply chain solutions serving all points of care.
Industry
Medical Equipment Manufacturing
Company size
10,001+ employees
Headquarters
Northfield, IL
LinkedIn followers
445,593
Total funding
$6.5B
Medline is the largest provider of medical-surgical products and supply chain solutions serving all points of care. Through its broad product portfolio, resilient supply chain and leading clinical solutions, Medline helps healthcare providers improve their clinical, financial and operational outcomes. Headquartered in Northfield, Ill., the company employs more than 45,000 people worldwide and operates in more than 100 countries. To learn more about how Medline makes healthcare run better, visit www.medline.com.
Offices: Three Lakes Drive, Northfield, IL 60093, US · Pune, IN · One Medline Place, Mundelein, IL 60060, US · Nuevo Laredo, MX · Mexicali, MX
Manufacturing and distribution of medical suppliesMedical Devicesand Supply ChainConsumer GoodsHealth CareHospitalityMedicalManufacturing
Medline is the largest provider of medical-surgical products and supply chain solutions serving all points of care.
Industry
Medical Equipment Manufacturing
Company size
10,001+ employees
Headquarters
Northfield, IL
LinkedIn followers
445,593
Total funding
$6.5B
Medline is the largest provider of medical-surgical products and supply chain solutions serving all points of care. Through its broad product portfolio, resilient supply chain and leading clinical solutions, Medline helps healthcare providers improve their clinical, financial and operational outcomes. Headquartered in Northfield, Ill., the company employs more than 45,000 people worldwide and operates in more than 100 countries. To learn more about how Medline makes healthcare run better, visit www.medline.com.
Offices: Three Lakes Drive, Northfield, IL 60093, US · Pune, IN · One Medline Place, Mundelein, IL 60060, US · Nuevo Laredo, MX · Mexicali, MX
Manufacturing and distribution of medical suppliesMedical Devicesand Supply ChainConsumer GoodsHealth CareHospitalityMedicalManufacturing