Senior Supplier 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 Convatec Website.

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.

Position Overview:

The Senior Supplier Quality Engineer identifies, leads and executes large scale complex and strategic projects which maintain and enhance ConvaTec's Global Supplier Quality and External Manufacturing program. Furthermore, the Senior Supplier Quality Engineer is the recognized subject matter expert in the management and auditing of external manufacturing suppliers to ConvaTec.

The role is focused on being the Global Quality point of contact for projects and management of activities relating to external manufacturing quality for all four of Convatec's business units, and where necessary will support the Senior Supplier Quality Manager in the development of their team and processes.

The job holder will not only demonstrate, but also support establishing the highest Quality standards and will embrace/drive Convatec core mission, values, and priorities.

Key Responsibilities:

1. Identify, manage, and develop contract manufacturers according to established organization quality standards and policies.
2. Lead and provide input into global quality standards and policies regarding supplier quality/contract manufacturing management, supplier quality performance and supplier selection process, ensuring compliance to industry and regulatory standards.
3. Represent Convatec as a subject matter expert in Global Supplier Quality and External Manufacturing Quality during audits.
4. Support the maintenance of ConvaTec's Global Supplier Quality program, whilst driving opportunities for improvement.
5. Leads, identifies, and establishes processes and measures for maintaining, and improving supplier performance metrics, policies, and procedures in administering quality relationships with suppliers and external manufacturers globally.
6. Actively resolves contract manufacturer-related issues associated with quality or poor performance to supplier performance metrics.
7. Collaborates with the procurement and R&D teams to identify and certify new and/or alternative suppliers/manufacturers to mitigate supply risks or support new product launches.
8. Use and promote the benefits of structured and standardized Lean / Six Sigma / KT methodology for process improvement and development.
9. Conduct Supplier and external manufacturer audits.
10. Provides advice and training on quality processes and procedures relating to supplier quality / external manufacturing quality to ensure compliance with regulatory and organizational standards.
11. Leads and manages large-scale projects or processes relating to supplier quality and external manufacturing.
12. Raise appropriate questions or concerns regarding regulatory compliance to appropriate authorities regarding Purchasing Control activities.
13. Quality Subject Matter Expert support with R&D and external Manufacturing teams to complete trials, Technical & Statistical studies such as MSA, VSM, and Gage R-R at external manufacturers, including introduction of new products.
14. Provides leadership as subject expert in Statistical Sampling, Quality Sampling, CTQ Characterization, Risk Management activities, and statistical process controls at external manufacturers.
15. Drives significant change requests through to closure for our ECCF and CCR process.
16. Collates and shares information/data through reports and follows up on identified improvement opportunities. Actively participates and/or drives Quality System improvements as required.
17. Manages complex external manufacturing Investigations relating to suppliers issues through the SCAR and CAPA process.
18. Demonstrate high commitment to quality and customer service based on customer needs.
19. Build strong relationships with customers, suppliers, senior stakeholders, and support groups worldwide to meet the demands of a changing business environment.
20. Coaches, reviews, and appropriately delegates work with lower-level professionals.
21. Demonstrates strong technical knowledge and principles in relation to medical devices in line with ISO13485, ISO9001, GMP Parts 201 and 211, EU MDR.

Authority (if applicable):

Signatory of CAPA/NCR and SCAR-related approvals in Trackwise.
Signatory sign-offs of ECCF changes.
Signatory sign-offs of Supplier Audits.
Signatory sign-offs of Supplier Quality Agreements.

Skills & Experience:

1. Minimum 5 years of experience in the medical device industry.
2. Minimum 3 years of experience in relevant engineering and or Supplier Quality /External Manufacturing Quality Control.
3. Advanced knowledge in internal and supplier related CAPA/ NC/ SCAR execution.
4. Strong knowledge of regulatory requirements that affect the medical device manufacturing business and put policies and systems in place to achieve conformance: QSR Part 820, ISO 13485, MDD 93/42, ISO 9001, GMP Parts 201 and 211, EU MDR.
5. Knowledge of ISO 14971 Risk Management.
6. Ability to negotiate and partner with internal and external customers to enhance operational effectiveness.
7. Demonstrated Statistical skills and ability to establish and respond to supplier and external manufacturer related metrics.
8. Strong project management skills and deployment, with understanding of DMAIC principles.
9. Strong prioritization and coordination skills.
10. Ability to work with electronic databases (i.e. Documentum, Trackwise, SAP).
11. Advanced computer management skills including Microsoft Word, Excel and Visio.
12. Proactivity and flexibility to meet priorities and achieve deliverables.
13. Ability to negotiate and partner with internal and external customers to enhance operational effectiveness.
14. Can strategically lead, establish strategies and translate them into specific objectives and action plans.

Qualifications/Education:

1. BS or higher degree qualified in Science or Engineering.
2. Quality Auditor or Lead Auditor certification is required in ISO9001 or ISO13485.
3. Lean Six Sigma Greenbelt is preferable.

Team

N/A - reporting into Senior Director, Supplier and Distribution Quality with cross functional interaction with the wider Supplier Quality and external manufacturing teams.

Principal Contacts & Purpose of Contact

1. Internal - R&D, Operations, Marketing, Packaging, Labelling, and Regulatory. Procurement Corporate Quality functions.
2. External - Contact Manufacturers, Raw Material and Component Suppliers, Service Providers, Distribution Centres and Consultants.

Travel Requirements

The position may involve travel up to 20% of the time to Convatec sites and supplier locations globally.

Working Conditions

Remote, presence at the local office may be required based on in-country legal requirements and for specific meetings/projects/events.

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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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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