Principal Quality Engineer

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

Position Overview:

Principal Quality Engineer is responsible for ensuring the quality of Controls, Products and Processes to meet acceptable industry standards in compliance; through systematic monitoring, verification, and improvement that guarantees stability of inputs and outputs.
This role is accountable for the Quality Assurance and Risk Management activities in changes to product and processes in the site and its related products. Develops and maintains quality controls to ensure proper mitigation of risks related to design and manufacturing, to maximize expected benefits in terms of safety and efficiency of products delivered to customers.

Key Duties and Responsibilities:

Supervise a team of Quality Engineers to achieve Quality Engineering objectives. • Identify, develop, and implement projects for continuous improvement of quality controls, product, and processes.

Plan and administrate tasks assigned to Quality Engineers, ensuring Quality Assurance and Good Industry Practices during Risk Management processes, Change Controls, Product and Process Validations in existing, transferred, and new products.

Support complaints investigations, root cause analysis, implement actions to improve customer satisfaction, product safety and efficiency.

Ensure adequacy and compliance of Site Master Validation Plan.

Accountable for Validation processes and Risk management during internal and external Audits.

Lead CAPA events (Corrective Actions and Preventive Actions).

Support site Audit processes and Continuous Improvement plans for the site.

Skills and Experience:

Manufacturing Quality/ Engineering experience in Medical Device environment (ISO 13485:2003, ISO 14971: 2019) – 5 years preferably.

Process validation knowledge and experience.

Computer System Validation knowledge and experience.

Project Management knowledge and experience, preferably.

Risk Management assessments and files (pFMEA, HA, Risk Assessments).

Experience supervising, coaching, or mentoring Engineering roles – 3 years preferably.

Data analysis and statistical tools using softwares knowledge and experience.

Strong Interpersonal skills.

Knowledge of Change Control management and assessments. Process Improvement knowledge, using Lean/ Six Sigma tools and principles.

Qualification and Education:

Degree, preferably in Engineering.

Six Sigma Certification (Green Belt or Black Belt), preferred. Education in ISO 13485:2003, ISO 14971: 2019, preferred.

Fluent English.

What you’ll get:

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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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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