Quality Engineer, Advanced Woundcare

at  ConvaTec

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
We are guided by our five core values, that shape the way we work, every day: Improve Care, Deliver Results, Grow Together, Own It and Do What’s Right.
At Convatec, we’re transforming our business for the better. Better products. Better ways of working. And better ways of delivering for our customers and each other. We’re aiming for nothing short of excellence. Join us on our journey to #ForeverCaring as a Quality Engineer, Advanced Wound Care, and you’ll do the same.
The Quality Engineer, Advanced Wound Care role will be visible to the shop floor, new product development projects, you will support Quality initiatives, Advanced Operations Quality focus for AWC & other Quality and process improvements through the use of chemistry or chemical engineering knowledge, SPC, Process Capability, and Quality tools.
The role is focused on being a Quality support for multiple projects within AWC and handling of launching of new products 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.

SKILLS & EXPERIENCE:

• 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
• 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.

QUALIFICATIONS/EDUCATION:

• Degree or equivalent in science, engineering, or related discipline
• Fresh Graduate in science, engineering or related discipline

TRAVEL REQUIREMENTS

• Percentage of working time involving travel, and travel destination(s) Example: Position may involve travel up to 20% of the time, mostly within Europe but overseas travel is expected. Most trips will include overnight travel

• Use and promote the benefits of structured and standardized Lean / Six Sigma / KT methodology for process improvement and development.
• Works closely with R&D, Manufacturing teams where appropriate to complete trials, Technical & Statistical studies such as MSA, VSM and Gage R-R.
• 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.
• Work with internal team members cross-functionally and external partners around the globe while maintaining professionalism at all times
• Representing the ConvaTec Advanced Operation Quality function, actively contributes to the development of Existing Products within the Design Control process.
• Responsible for reviewing design control and risk management document outputs.
• Works closely with R&D, Manufacturing teams and suppliers where appropriate, working on New product development and technical projects, ensuring compliance throughout.
• 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.
• Support Cost of Quality and Automation Projects to aid with AWC while aiding the Advanced Operation team.
• Provides support as subject expert 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.
• Provide support towards Design and manufacturing feasibility towards AWC New Product Introduction in Quality aspects while focusing at Critical to Quality.
• Works with AO Quality and Other Quality team to ensure specifications critical to product quality are fit for purpose and transferred effectively from R&D into operations.
• Act as product stewards for process FMEA and provides input on process validation to ensure manufacturing routes are capable of producing 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.
• Collates and shares information/data through reports and follows up on identified improvement opportunities. Actively participates and/or drives Quality System improvements as required.
• Supports continuous improvement initiatives, process improvements to address operational issues using statistical process control (SPC) and Quality tools e.g. pareto, process capability, correlation analysis, etc.
• Supports and process NC and/or Corrective and Preventive Action (CAPA) to address operational issues including complaints and continuous improvement initiatives.
• Supports with project related document and technical review.
• 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