- Conduct Internal Audit and Corporate Audits as assigned.
- Ensure robust investigation of Audit Observations and adequate CAPA action plans, ensure alignment in Audit Non Conformance Ratings and review/approve CAPA as required related to Internal Audit Non Conformances.
- Support External audit process execution, from readiness to execution, help team to resolve compliance issues and timely and robust manner.
- Conduct review of External Audit CAPA effectiveness by collecting and analysing data accordingly
- Maintain deep knowledge and keep abreast of all current regulatory and statutory expectations.
- Develop and Deploy related Compliance trainings.
- Lead and execute the process to maintain Internal Quality Agreements in compliance.
- Execute Regulation/Standard Gap Assessments and implementation as required.
- Support Quality Improvements projects to compliance/enhance compliance.
- Execute Gap Assessments and implementation as required in relation to Quality Compliance Assessments.
- Practical knowledge and experience in diverse functions of the medical industry/pharma
- ISO13485 Auditor Certification and experience in executing audits
- Excellent written and verbal communication skills, with an open, collaborative, interactive leadership style
- Ability to build and nurture strong and positive relationships with other leaders to partner effectively
- Balanced technical understanding of products and processes combined with business and compliance acumen
- Excellent use of Microsoft Office applications, ability to generate report in Excel and other systems for data analysis
- Minimum of B.S., or equivalent, in a scientific/technical discipline is required.
- Five to Ten years in the medical device and/or pharmaceutical industry.
- Two to Four (2-4) years' experience in a QA/QC role.
- Practical experience and global mastery in global quality standards and regulations governing medical products.
- Six Sigma Green Belt/Black Belt certification or equivalent (preferred)
Remote working
Speaking: English
Writing/Reading: English
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Senior Quality Compliance Engineer - Deeside, United Kingdom - Convatec
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. Group revenues in 2022 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visitOur 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 #ForeverCaring as Senior Quality Compliance Engineer, and you won't either.
Job Summary:
This is a key role within the Global Quality function, where you will have the objective of maintaining high quality standards for the product manufacturing and compliance with all applicable regulatory requirements. The scope is focused on Quality Compliance processes and is assured via the execution of the Corporate Quality Compliance Programs.
Key Duties & Responsibilities:
Internal Audit Process:
External Audit Process:
Compliance and Education Program:
Internal Quality Agreement:
Regulatory and statutory expectations:
Integration/Divestiture:
The Ideal Candidate should bring the following qualities to the role:
Principal Contacts:
Internal: Global quality management, Site Quality Leads, R&D, Regulatory Affairs, Clinical Affairs, Quality Engineering, Quality Associates and all other functions as required by the role
Travel Requirements:
Periodic travel required. Once per Quarter.
Education/Qualifications:
Working Conditions:
Language Skills Required:
Our ambitions will bring the very best out in you. You'll be pushed to aim higher and really own your work. You'll be encouraged and supported to make things happen too. It can be challenging. But, as the progress you make will help improve the lives of millions, it'll be worth it.
This is stepping up to a challenge.
This is work that'll move you.
#ForeverCaring #ForeverConvatec #WeAreConvatec
#LI-DB1
#LI-Remote
Beware of scams online or from individuals claiming to represent Convatec
A 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 opportunities
Convatec 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 Representatives
Convatec 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
