Engineer – Business Quality bei Convatec

About 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 more than 10,000 colleagues, we provide our products and services in around 90 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 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit http://www.convatecgroup.com

The role:

• Responsible for maintaining a state of audit readiness by maintaining Quality Systems, including, Internal audit, change control, EDMS, supplier control and represents Quality Management on the more complex projects that involve coordination of several quality resources.
• Supports key areas in Supplier Control,  NC/CAPA and audit processes including monitoring process performance and implementing continuous process improvements.

Key Responsibilities:

• Identifying, coaching, and managing suppliers according to the organisation’s quality standards and policies.
• Providing advice and training on supplier quality procedures and conducting audits to ensure compliance with the organisation’s requirements and applicable standards/regulations.
• Focus on establishing, maintaining and improving supplier performance metrics, policies, and procedures in administering quality relationships with suppliers.
• Supporting and leading where appropriate, supplier selection, evaluation and
• approval.
• Provides a QA review and approval of documents (e.g. procedures within the EDMS, Laboratory Equipment qualification documentation, QA review/QA manager review for NCs within TrackWise)
• Maintains an excellent up to date knowledge of international Quality Regulations and advises management of implications for the site.
• Works closely with other functions on site, to communicate and implement relevant Quality Systems
• Support the general activities with the Quality Department
• Prepares routine metrics relating to the Quality System and the routine Management Reviews.
• Supports inspections by regulation bodies, including BSI.
• Proficient in EDMS, TRACKWISE, SAP, and spreadsheet / database software

Authority (if applicable):

• Authority to review and approve quality records.
• Conduct internal audits and generate reports.

Skills & Experience:

• Keen sense for attention to detail and ability to apply skillset to document and record reviews.
• Excellent sense of prioritization and time management, operating against multiple deadlines.
• Demonstrated experience of project management and/or leading project implementations.
• Ability to deal and lead through difficult situations with tact and professionalism.
• Analytical mindset and able to influence others using data driven decisions.
• Demonstrate problem solving and trouble shooting skills.
• Experience of using electronic quality management system software.

Qualifications/Education:

• Degree, or equivalent, in Science or Engineering.
• Demonstrated experience in Pharma/Medtech industry.
• Knowledge and experience of working with a Quality Management System within Medical Devices.
• ISO 13485 lead auditor or internal auditor qualification.
• Microsoft Office skills are essential; Statistical tools (e.g. Minitab) and SAP knowledge desirable.

Principal Contacts & Purpose of Contact

Internal -

• Quality management
• Global quality – For updates to quality processes as well as quality projects.
• GDC departments – To support as part of the quality function in GDC. 

External -

• Notified bodies – As part of external audits.

Travel Requirements

This position may require some Domestic and International travel to be undertaken, which will necessitate overnight stays.

Languages

• Speaking:                   Yes                 English

• Writing/Reading:        Yes                 English

Working Conditions

• Hybrid working in an office environment (CTEC Deeside)/work from home.

Ready to join us?

At Convatec, we’re pioneering trusted medical solutions to improve the lives we touch. If you’re ready to make a real impact, apply today and help us bring our Forever Caring promise to life.

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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 [email protected].

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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If you are an active employee at Convatec, please do not apply here. Go to the Career Worklet on your Workday home page and View "Convatec Internal Career Site - Find Jobs". Thank you!