Quality Engineer

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.com
Our 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

The Role:

The Quality Engineer, Advanced Wound care role will be visible to the shop floor, new product development projects, you will support Quality initiatives,

As a Quality Engineer, you will be responsible for risk management and adherence to applicable regulations and internal procedures. You will work closely with R&D, Manufacturing teams and suppliers where appropriate, working on post-market activities and lifecycle management, ensuring compliance throughout. You will provide leadership as a subject matter expert in Risk Management activities from R&D into operations

The role is focused on being a Quality support for multiple projects within AWC and handling of launching of new products and Life Cycle Management within AWC Business Unit. The role would include taking part for handling of non-conformances/CAPA’s/Complaints, etc.

The role drives and supports key quality and engineering activities such as pFMEA, process and product audits, Engineering and capability studies support, Quality control plan, documentation creation and review and the enforcement of Good Manufacturing Practice (GMP) standards. The role is focused on driving towards right first time and the role will be a successful lead for both internal and third-party manufacture projects.

Provides key supports to validation activities, generation and review of process risk assessment (e.g., pFMEA), and development or implementation of in-process controls, tests, checks, and inspection to support process and continuous improvement initiatives. – test method validation

The job holder will demonstrate the highest Quality standards and will embrace/drive Convatec core mission, values, and priorities.

Key Responsibilities

• Use and promote the benefits of structured and standardized Lean / Six Sigma / KT methodology for process improvement and development.
• Aid and assist Third party manufacturing teams to work with Quality agreements and conduct site visits to ensure project completion and right first time quality is driven.
• Responsible for reviewing design control and risk management document outputs. 
• Uses technical and GXP knowledge to influence and assure Quality and Compliance in Design and develops plans for New Product Development/Post Launch / lifecycle management activities. 
• Provides leadership as subject expert in Risk Management activities and assists Design Control and actively supports and influences R&D teams in the translation of User Needs to Design Inputs, Design Outputs, Design Verification and Design Validation activities, and timely Design Reviews, with particular involvement in Design Transfer activities.
• Ensuring specifications critical to product quality are fit for purpose and transferred effectively from R&D into operations, and subsequently monitored post launch to ensure effective when moving into business as usual.
• Support in Statistical Sampling, Quality Sampling, CTQ Characterisation, Risk Management activities and assists Design Control/Transfer and actively supports and influences R&D teams in the translation of User Needs to Design Inputs, Design Outputs, Design Verification and Design Validation activities, and timely Design Reviews.
• Act as product stewards for process FMEA and provides input on process validation to ensure manufacturing routes can produce product to specifications.
• Actively lead activities for process improvements within new product development and site activities which can involve working with process engineering and validation teams.
• 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 audits as required. Uses auditing as a proactive tool for improvement as well as compliance and challenges existing practice where appropriate.  
• Execute elements of quality management of suppliers (onboarding, evaluation, SCARs) to support new or existing products
• Act as product stewards for process FMEA and provides input on process validation to ensure manufacturing routes are capable of producing product to specifications.
• Champions Risk Management activities through leadership, facilitation and active support during Product Development, and Post Launch Change Control activities. Demonstrates 2 © Convatec 2023 courage to drive Risk Management in decision-making to determine sound and timely decisions that balance compliance, business and product performance.
• Responsible for Post Launch Reviews as appropriate. 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.
• Supports compliance with and maintenance of quality system documentation in line with regulatory standards including ISO 13485, 21 CFR Part 820. Improve and drive performance of quality system processes in order to meet quality and site KPI’s.

Key requirements

• Key competencies and characteristics candidates need to demonstrate in order to help build our diverse, inclusive culture and to be successful in the role. Examples include:
• Degree or equivalent in science, engineering, or related discipline
• Minimum 2+ years in a similar role, preferably within the medical device industry but not essential.
• Understand complaint handling systems in conjunction with 21 CFR 820 AND 803 as well as ISO 13485 MDSAP knowledge, ISO 9001, GMP Parts 201 and 211
• Strong knowledge and experience of CAPA and NC.
• Knowledge and experience of Trackwise, PowerPoint and SAP. Preferably MINITAB.
• Strong Interpersonal skills while experience in Cross functional deployment of projects.
• Six Sigma green belt qualified and / or demonstrated ability in the use of quality engineering tools and techniques (quality core tools) and data interpretation.
• A practical working knowledge of implementation of change control, and of all aspects of the process and computer systems validation lifecycle (preferred)
• Demonstrated ability to lead multiple projects and motivate cross functional teams whilst ensuring that deadlines are met.
• Competent auditor. Experience in hosting or acting as SME during external regulatory audits.
• Experience in implementing/review of pFMEA.

Education/ Qualifications

• Degree or equivalent in science, engineering, or related discipline
• Minimum 2+ years in a similar role, preferably within the medical device industry but not essential.
• Regulatory and compliance knowledge of validation
• Knowledge and experience of working with a Quality Management System within Medical Device manufacturing

Travel Requirements

Percentage of working time involving travel, and travel destinations

Example: Position may involve travel up to 25% of the time, mostly within Europe but overseas travel is expected. Most trips will include overnight travel.

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.

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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.

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