QMS Specialist

Job title:

QMS Specialist

Company:

Convatec

Job description

Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring.
Our solutions provide a range of benefits, from infection prevention and protection of atrisk skin, to improved patient outcomes and reduced care costs. Convatec’s revenues in 2023 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC).
To learn more about Convatec, please visit http://www.convatecgroup.comChange is everywhere at Convatec. It’s transforming our business, and helping us improve millions of lives. And we’re nowhere near finished. Across every part of our business, we’re pushing for better. Join us on our journey to #ForeverCaring as a QMS Specialist and you’ll do the sameAbout the role:
QMS Specialist is responsible for ensuring constant development and maintenance of the quality management system (QMS) and to ensure that QA processes are in compliance with regulatory requirements in the countries where the company’s products are marketed.Key Responsibilities:

• Ensure simplification of procedures and processes, so the QMS always aims at and reflects best practice.
• Ensure quality awareness throughout the organization e.g. via training and education of employees in quality assurance and best practice throughout the organization.
• Ensure and develop customer communications in relation to quality aspects
• Daily tasks within the CR process
• Approve documents in the QMS (formalities, system coherence, standards etc)
• Develop quality procedures and processes, where necessary in close cooperation with corporate QA
• Ensure coherence and structure in the documents of the QMS
• Ensure that all elements and requirements in relevant standards are implemented and maintained in the QMS
• Plan and carry out thorough training of employees in the QMS
• Aim at simplification of the procedures in the QMS, so they are value adding and reflect best practice and global alignment
• Maintenance of Quality Manual, Cross Reference lists between QMS and applicable standards/regulation
• DHF overview, allocation of new DHF numbers, DHF’s after transfer to QA
• Participates in QA projects in relations to QMS and training
• Participate and conduct audit readiness tasks, as required, for internal and external audits

Authority:

• QMS specialist is capable of deciding the following;
• Document requirements during CR process
• QMS guidance with regards to structure and global alignment
• Method for completion of training in QMS

Authority within QMS:

• Sign and approve Change Request’s in QMS

• Sign and approve as substitute for Senior QMS Manager on Change Request’s in QMS

Skills & Experience:

• MS Office, Lotus Notes, TrackWise, Documentum; Visio
• Training in EU MDR, ISO 13485 and MDSAP (required)
• Strong Quality mindset
• Positive and open minded
• Collaborative skills for use in daily support
• Engaging and positive towards changes and daily challenges
• Initiative and able to identify improvements.
• Self-motivated and encouraging as a colleague

Qualifications/Education:

• Educated as e.g. Engineer, Pharmaceutics, Veterinarian, Medicine AND
• Experience within Quality Assurance in a Medical Device industry with

6 years of experience within QA processes and QMSLanguages:

• Speaking: Yes English
• Writing/Reading: Yes English

Working Conditions:
Hybrid working – 2-3 number of days per week in the office driven by business requirements as Convatec has a flexible approach to office working
Special Factors:
Extra hours can be expected during internal and external audits.Our transformation will change your career. For good.You’ll be pushed to think bigger and aim for excellence. Your ideas will be
heard, and you’ll be supported to bring them to life.There’ll be challenges. But, stretch yourself and embrace the opportunities, and
you could make your biggest impact yet.
This is stepping outside of your comfort zone.
This is work that’ll move you.#LI-DS4#LI-HybridBeware of scams online or from individuals claiming to represent ConvatecA formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you’re unsure, please contact us at .Equal opportunitiesConvatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.Notice to Agency and Search Firm RepresentativesConvatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.Already a Convatec employee?If you are an active employee at Convatec, please do not apply here. Go to the Career Worklet on your Workday home page and View “Convatec Internal Career Site – Find Jobs”. Thank you!

Expected salary

Location

Osted, Sjælland

Job date

Wed, 19 Feb 2025 06:15:48 GMT

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