Specific Duties And Responsibilities
Maintain and update quality management system documentation, including policies, procedures, work instructions, forms, and records Create, revise, and archive quality documents ensuring they meet regulatory and organizational standards Coordinate the review and approval process for quality documents, ensuring timely completion and dissemination Ensure that all documentation is up to date and accurately reflects current practices and regulatory requirements Prepare and organize documentation for internal and external quality audits, ensuring readiness and compliance Conduct internal audits - ISO 9001:2015 standard and internal procedures Track audit findings and follow up on action items, ensuring timely resolution and documentation of corrective actions Manage document control processes, including version control, approvals, and distribution Document non-conformance reports (NCRs) and corrective action requests (CARs), ensuring accuracy and completeness Support the QMS Manager with external audits - Supplier, Customer, and Competent authority Qualifications & Experience
Minimum of 1 year of experience in a similar role Internal Quality auditor experience within the medical device manufacturing, distribution, or other regulated environment would be advantageous ISO 9001:2015 Auditors Course Skills
Knowledge of the Q-Pulse program is preferred but not required Be well organized, with strong time management skills Excellent communication and listening skills Ability to obtain, analyze, and present information Computer literate, including Outlook, Excel, Word, and PowerPoint Strong analytical and problem-solving abilities Ability to work independently and as part of a team How We'd Like To Work Together
Our core values, titled our Medtech Mindset, guide our culture and work environment:
We Go Forward Together: We operate as a unified team, leveraging diverse specialties to make swift, collaborative decisions and embrace progress over perfection We Take Our Business Seriously: We prioritize compliance and risk management to ensure the best outcomes for our patients and partners, supported by our innovative portfolio and commitment to sustainability We Deliver Exceptional Results: We focus on quality, customer satisfaction, and commercial success to achieve outstanding results for our patients, customers, and business Uniphar Medtech is an equal opportunities employer. The Company
Uniphar Medtech comprises 10 businesses across 21 markets and is the medical device arm of the Uniphar Group. Uniphar Medtech represents global leading medical device manufacturers across a multitude of specialties. We train, we educate, and we support our customers through dedicated clinical specialists across Sales & Technical Service, Clinical IT, Clinical Applications, Training and Education, and Customer Service. We are more than a distributor; we are a total solutions provider. Each of our businesses competes under their individual brand identity and respective specialties. Uniphar Medtech is the umbrella structure for all 10 brands and, in addition, incorporates our centralized support functions across Quality and Compliance, Logistics, Warehousing, Operational Excellence, Marketing, HR, Finance & IT. Business website:
https://www.unipharmedtech.com/
Uniphar Medtech is a Division of the Uniphar Group.
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