Product 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 atrisk 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
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 a Product Quality Engineer and you’ll do the same

Your overall purpose, as a Product Quality Engineer, will be to participate from the beginning of a new project and achieve: Compliance with internal and external requirements according to standards, customers, and authorities. This is done by conducting- or participating in all relevant projects and that the quality system is developed, maintained, and improved for instance through internal and external audits

Key Responsibilities:

Competency Act in the role Product Quality Engineer (PQE) in projects.
Development of the quality system by:

• update and develop procedures, instructions, specifications, and batch control cards.
• facilitate that procedures are followed.
• draw up and/or follow up on internal deviations, rationales, statements, and preventive actions.
• To conduct teaching and coaching during introduction of new procedures, instructions, specifications, and modifications, otherwise.

To participate in projects including:

• Responsible for the Risk Management Plan including Use/Design FMECA and Process FMECA within a new project.
• Responsibility for QA/RA Requirement Plan including 510(k) application.
• Responsible for the Qualification Plan including size of PQ and sampling size.
• Responsible for the DMR with regard to overall content and communication between departments and sites to secure a complete DMR before qualification of design.
• Responsibility to ensure adequate communication/information within the QA/RA department regarding own projects, thereby ensuring coordination of tasks.
• Review of protocols and reports (documentation) regarding verification/validation within a projects concerning changes releated to products and/or processes.
• Participate in design review and design examination.
• Support development department regarding requirements and regulations.
• Assist the project team regarding external tests and verifications. Included is biocompatibility and stability testing.

Skills & Experience:

• Competent in oral and written English is a must
• Knowledge of the basic requirements of the FDA QSR, GMP and ISO 13485 or equivalent
• Experience with validation, measurement techniques and statistics
• Auditor experience (preferred)

Qualifications/Education:

• Engineer, Technician (chemistry, food or process technology) or similar relevant training
• Minimum of 3 years experience in similar position (preferred)

Travel Requirements

Expected 0-10 days

Working Conditions : Onsite

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.

#LI-DS4

#LI-Onsite

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 [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!