Senior Quality Compliance Engineer page is loaded Senior Quality Compliance Engineer Apply locations Reynosa, Mexico time type Full time posted on Posted Yesterday job requisition id JR00009868 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 visit http://www.convatecgroup.com This position 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.
Responsibilities: Internal Audit Process :
Execute the Internal Audit Process in the organization according to the site schedule.The position provides leadership, oversight, and strategic guidance for site issues related to Quality Compliance.Ensure that the Quality Management System is periodically evaluated and audited and appropriate CAPA is taken to meet the business and regulatory requirementsEnsure robust investigation of Audit Observations and adequate CAPA action plans, ensure alignment in Audit Non Conformance RatingsLiaise with Site Leaders on assessing gaps and defining actions plans related to Internal Audit Non ConformancesAnalyse Internal Audit data for systemic trends, drive compliance and improvement in Internal Audit MetricsGather and analyse data as an input to the Management Reviews to allow meaningful reviewSupport Internal Audit and Corporate Audits as required External Audit Process : External audit process execution, from readiness, to execution, response and tracking of commitments.Provides leadership, oversight, and strategic guidance for companywide issues related to Quality compliance.Liaise with Quality Leaders on assessing gaps and defining actions plans related to External Audit Non-Conformances, reviewing and approving responses to Notified Body/Health Authorities as applicable.Gather and analyse data as an input to the Management Reviews and/or CAPA Review Board Compliance and Education Program :
Contribute to the development of Corporate training materials to execute the Internal Audit Program and compliance education trainings (QSR, ISO, GMPsCoach/train internal auditorsKeep abreast of all current regulatory and statutory expectationsSupport Regulation/Standard Gap Assessments and implementation as required Inspection readiness: Enable successful product realization and compliance through readiness compliance activities, assessments, and other consultation.Ensure sites are in permanent state of inspection readiness using readiness toolsSupport coordination of responses to Notified Bodies to ensure SME and Management engagement and buy-inPerforms and lead Gemba walks as part of readiness activitiesKey Requirements Internal Lead 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. Qualifications/Education Minimum of B.S., or equivalent, in a scientific/technical discipline is required.Five to Ten (5-10) 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.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! About UsConvatec is changing. We're transforming our business, fueled by a fierce determination to improve the lives of millions more customers around the world.
Our shared focus, and the sheer drive of our people, are giving us real momentum. They're also making us a uniquely invigorating place to work. Join us and, whatever your role, you'll be pushed and challenged every day. You'll be supported too, empowered to spark and drive change where it matters most.
We have a uniquely dynamic, sometimes demanding environment. But if you're motivated, and as focused on delivering for patients as we are, it'll bring the very best out in you. You'll never stand still. And you might just make the biggest impact of your entire career.
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