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

　　Position Overview:

　　Representing Quality Management, actively contributes to the development of New Products within the new product development process.  Responsible for ensuring that Design Control requirements including development of Design and Development plans meet regulatory and applicable procedural requirements.  Responsible for reviewing and approving design control document outputs.  Works closely with Manufacturing QE’s to assure appropriate Validation Planning and a robust Design Transfer. 

　　Key Responsabilities and Skills:

　　Uses technical and GXP knowledge to influence and assure Quality and Compliance in Design and develops plans for Post Launch / lifecycle management activities. 

　　Provides leadership as subject expert in Design Control and actively supports and influences development teams in the translation of User Needs to Design Inputs, Design Outputs, Design Verification and Design Validation activities, and timely Design Reviews.  Develops and assures that Quality Control Plans are complete and meet the standards and requirements appropriate for the type of product.  

　　Responsible for Post Launch Reviews.  Investigates product / process performance issues and leads or participates in multifunctional evaluation of products in the market.  Evaluates data using statistical tools.  Leads or support Complaint investigations through Root Cause Analysis and effective Corrective or Preventive Actions (CAPA).  Leads or actively supports Product Change Control.

　　Performs internal and supplier process audits as required to support business.  Uses auditing as a proactive tool for improvement as well as compliance and challenges existing practice where appropriate.  

　　Champions Risk Management activities through leadership, facilitation and active support during Product Development, and Post Launch Change Control activities.  Demonstrates courage to drive Risk Management in decision-making to determine sound and timely decisions that balance compliance, business and product performance.

　　Requirements:

　　Bachelor degree in Science or Engineering.

　　3 - 5 years of experience working within the area and using quality tools such as Quality Control Plans, Test Method validation and transfer, Statistics, Experimental Designs, Root Cause Analysis, Process validation, Process Optimization.  . Demonstrated knowledge of Regulatory and GXP Compliance requirements such as QSR Part 820, MDD 93/42, GMP Parts 210 and 211, ISO 9001 / ISO 13485. Demonstrated knowledge and experience of Risk Management and the application and use of Risk Management Tools such as FMEA, Process Mapping, Hazard Analysis, ISO 14971.

　　Must be proficient with PC programs, i.e. Excel, Word, and PowerPoint.

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　　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.

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