Advanced Operations 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. 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.

Change is everywhere at Convatec. It’s transforming our business and helping us improve millions of lives. And we’re nowhere near finished. Across every part of our business, we’re pushing for better. Join us on our journey to #ForeverCaring as an Advanced Operations Quality Engineer, and you’ll do the same.

The Quality Engineer, Advanced Operations role is a key and influential position for the introduction and implementation of all new product development projects, within the Ostomy & Continence Care business units. As the recognized Manufacturing Quality SME, the role actively engages with the project teams, ensuring all manufacturing quality aspects are considered, and the appropriate level controls implemented throughout all steps of the IDEAL process through to product launch and plant handover.

The role provides key support to validation activities, process risk assessment (e.g., pFMEA), generation, review, and approval of key documentation, and development or implementation of in-process controls, final inspection requirements (Including test method validation), and sampling plans & controls. Guidance on up to date and future thinking manufacturing & process quality control methodology, including process controls, manufacturing & inspection technology, and data monitoring, whilst always ensuring compliance to our own QMS, regulatory bodies, and the enforcement of Good Manufacturing Practice (GMP) standards.

Your key duties and responsibilities as an Advanced Operations Engineer:

• As the Advance Operations Quality Engineer, provide required deliverables to the new product IDEAL stage gated process in a timely manner for both internal and external manufactured devices.
• Serve as Manufacturing Quality subject matter expert in the introduction and implementation of all New Product. Provide guidance to the teams at each stage of the IDEAL process, challenging the team when necessary to ensure manufacturing quality is not compromised.
• Collaborate with the Design Assurance team through each step of the design transfer process to ensure alignment on product risk assessment and final essential design output (EDO) determination.
• Translate essential design outputs into manufacturing ‘critical to quality’ characteristics (CTQ’s) that must be effectively measured and controlled to confirm acceptable product quality.
• Key stakeholder in identification of appropriate test methods to monitor/measure CTQ performance against strict acceptance criteria. Support test method development where necessary to ensure accurate determination of product quality, ensuring variable data methods where possible.
• Responsible for providing manufacturing quality guidance on the selection of production and test equipment to ensure product quality, level of test accuracy, and data monitoring capability are at the required specification. Expectation to work with suppliers of equipment including site visits to ensure correct level of quality is built in and achieved.
• Provide vital input and governance to gage R&R and Test Method Validation activities to ensure correct approach is applied to obtain reliable and accurate data.
• Sole Responsibility for assessment and application of effective sampling plans at all stages of validation and final implementation into production to enable appropriate level of inspection of product quality, whilst providing a high degree of confidence. Act as sampling SME for project teams assisting on FAT/SAT and other process development stages.
• Support Process development team acting as SME for statistical techniques and approach for determining optimum operating window through Design of Experiments and identification of reliable process response data sources.
• Ensure all validation activities are conducted in compliance with procedure whilst providing confidence that the product will consistently meet all quality requirements once in full production. Write, review, and approve validation documentation as appropriate, including being the responsible author of the Master Validation plan.
• Owner representative of global procedures for Quality Control Procedure & PFMEA risk documents. Responsible for regular review and updates as required, as well as generating both documents for all NPD projects for new product.
• Support new product supplier quality management working with SQE representative to ensure that manufacturing quality is not impacted through raw material quality issues.
• Work with third party manufacturing partners to ensure require quality management system controls are in place and effective, conducting site visits to ensure compliance is maintained through to product launch and plant handover.
• Responsible for final handover of new product and processes to the plant quality team, ensuring all major concerns are remediated during the final ‘Business as usual’ stage through close monitoring and collaboration with the NPD project team.
  
  
  

About you:

• Manufacturing quality experience
• Strong process validation experience and computer systems validation lifecycle (preferred)
• Recognized Root Cause Analysis, problem solving lead/Facilitator supporting resolution to major product or process issues for new product introduction.
• Risk management experience - PFMEA, HA, DFMEA & UFMEA
• Experience in implementing/review of pFMEA. + QCP’s
• Demonstrated ability to act as manufacturing quality SME in business-critical projects, prepared to challenge decisions whilst also motivating cross functional teams and ensuring that deadlines are met.
• Experience in New Product Development supporting implementation of new product from ideation through to launch via adherence to a structured or stage gated control methodology.
• Knowledge and experience of statistical software use, 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.
• 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
• Flexibility
  
  
  

Education/ Qualifications:

• Degree or equivalent in science, engineering, or related discipline
• Minimum 3+ years in a similar role, preferably within the medical device industry but not essential.
• Knowledge and experience in operations and manufacturing quality.
• Competent in the development and change of key process documentation i.e. Standard Operating Procedures, Process instructions, material specifications etc.
• Knowledge and experience in application of Statistical sampling techniques
• Experience performing risk analysis & management.
• Negotiation, persuasion and influencing skills to achieve objectives.
• Experience of notified body audits and FDA inspections
• Experience in project/process management.
• Confident presentation skills
• Operating in a team environment, working on multiple projects, and changing priorities.
• Lean Principles and/or Six Sigma Green Belt
• Proficient in Office (Excel, Word, and PowerPoint), Statistical software (MiniTab, etc.), TrackWise.
• Communicative level of English language
  
  
  

Travel Requirement:

Position may involve travel up to 25% of the time, mostly within Europe, but may also include US, Dominican Republic and other global sites as required. Most travel will require an overnight stay.

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.

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 careers@Convatec.com.

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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