CAPA Specialist

Job title:

CAPA 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 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:CAPA Specialist is responsible for taking lead on the IC NC/CAPA process – including monitoring process performance and implementing continuous process improvement and to ensure that the IC NC/CAPA process are in compliance with regulatory requirements in the countries where the company’s products are marketed.Key Responsibilities:

• Provide continuous and rigorous assessment of NC/CAPA activities and documentation to assure compliance with NC/CAPA processes, FDA regulations, ISO 13485, and Medical Device Requirements through the review of NC/CAPA records.
• Ensure that NC/CAPA records are routed, reviewed, approved, and implemented in accordance with established procedures.
• Provide guidance, support, and mentor the NC/CAPA Owners, NC/CAPA Leads and CAPA meetings members regarding the NC/CAPA process, NC/CAPA best practices, NC/CAPA record content, and NC/CAPA software tools.
• Facilitate NC/CAPA Meetings, and support members and Executive Management with metrics and reporting on critical aspects regarding the status of the NC/CAPA process.
• Works cross-functionally with a sense of urgency to ensure timely, compliant, and effective NC/CAPA records.
• Participates in Corporate NC/CAPA meetings.
• Supports the development and implementation of Quality System NC/CAPA procedures, NC/CAPA software, and NC/CAPA training programs.
• Supports internal and external audits and inspections for NC/CAPA records and processes and other roles as needed.
• For TrackWise Event/CAPA Module: Identify and assist with the implementation of updates to the NC/CAPA TrackWise module; including participating in validation efforts e.g., user acceptance testing.
• Develops and reports quality assurance KPI’s as required. Collates quality data and presents for management review.
• Participates in QA projects in relation to NC/CAPA process and training
• Participate and conduct audit readiness tasks, as required, for internal and external audits
• Participate in planning and execution of Internal audits as NC/CAPA SME, as applicable
• Participate in planning and preparation of data for Management Review

Authority (if applicable):

• CAPA Specialist act as quality approver
• Act as NC/CAPA SME in IC
• NC/CAPA owner and NC/CAPA action owner
• Delegate for Senior QMS Manager as NC/CAPA process owner

Skills & Experience:

• MS Office, TrackWise, Documentum; Visio
• Training in EU MDR, ISO 13485 and MDSAP (required)
• Demonstrate methodical problem-solving skills in a fast-paced continuous improvement culture
• Strategic driver for a world class Nonconformance/CAPA process
• Demonstrate the highest Quality standards, and being able to impart knowledge and increase best practice across site
• Experience with medical device manufacturing environment is preferred
• Positive and open minded as a person
• 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 within the Medical Device industry with

3 years of experience with NC/CAPA process.Working Hours:Hybrid working – 2-3 number of days per week in the office driven by business requirements as Convatec has a flexible approach to office workingOur 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-ÁN1
#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, 05 Feb 2025 01:29:45 GMT

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