Quality Engineer

Job title:

Quality Engineer

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 at-risk 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.comOur search for better is changing the lives of our customers. It’s changing the careers of our people too – creating new challenges and opportunities all the time. We’re a business that never stands still. Join us on our journey to #ForeverCaringThe role:As our new Quality Engineer you will have a broad interaction with the organization and work within areas such as process validations, handling of non-conforming products and risk documentation just to name a few. As a part of the Quality Engineering team, you will also take part in other activities needed to maintain the right level of compliance in order to meet the expectations of our customers and relevant authorities.You will be part of a highly engaged team, where collaboration and a positive can-do attitude is highly valued. You will report to the Quality Engineering Senior Manager and your main work location will be in Denmark Osted (south of Roskilde). We offer flexibility to work from home. You can expect up to 15 travel days annually.Key Responsibilities:

• Support to assure compliance with internal and external requirements according to standards, customers and authorities.
• Support the Quality Management System, by developing, maintaining and improving procedures and instructions:
• Facilitate that approved procedures and instructions are followed
• Support in ensuring, that systems, documents, products and processes are in a validated state and fit for intended use by:
• Reviewing and/or approving specifications, plans, protocols and reports regarding verification/validation/revalidation/maintenance
• Participate in design review and design examination if needed
• Ensure timely handling of NC’s, CAPA’s, changes, audit findings, customer complaints, MIR and HHE’s
• Review and/or approval
• Follow up on assignments/records
• Participate in various risk management activities e.g.
• Write, update or approve p-FMEA if assigned to project, update, change or other
• Update and approve u-FMEA
• Update and approve d-FMEA

Additional responsibilities based on qualification

• Participate in planning and execution of audits
• Participate in MDR updates if needed

About youWe are looking for a candidate experienced within Quality Engineering. You are a team player, and you thrive in an international matrix organization characterized by cross-functional teamwork. You are pragmatic and operate with a sense of urgency to meet your deadlines. You enjoy a busy working day and can progress several tasks in parallel. You have proven analytical and problem-solving skills that will help you to take fast and well-founded decisions.QualificationsTo succeed in this role, you have:

• A Master’s or Bachelor’s degree in engineering, chemistry, biology, pharmacy or similar.
• A high level of language skills in English, both written and verbal
• Experience in Quality Management and the application of ISO 13485 and FDS 21 CFR part 820 in a medical device industry.

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-AN1#LI-OnsiteBeware 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

Fri, 04 Apr 2025 03:39:00 GMT

To help us track our recruitment effort, please indicate in your email/cover letter where (vacanciesin.eu) you saw this job posting.