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. 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
Our search for better is changing the lives of our customers. It’s changing the careers of our people too – creating new challenges and opportunities all the time. We’re a business that never stands still. Join us on our journey to #ForeverCaring
The role:
The supplier Quality Engineer is responsible of the IC Supplier quality activities including but not limited to supplier audits, qualification, monitoring, corrective and preventive actions, among others.
Responsibilities:
- Plan and execute the Suppliers Audit according to schedule, when applicable.
- Onboard new suppliers as per request and ensure suppliers are qualified accordingly
- Guide the organisation in relation to requirements for supplier controls.
- Monitor Supplier Audit Responses according to established metrics.
- Manage Suppliers performance according to established indicators.
- Manage and follow up corresponding Quality Agreements activities/process with the suppliers and site contacts, as applicable.
- Work with the supplier and procurement teams to solve any issue that may affect quality system and products.
- Oversea the local SCAR system, including activities such as follow up on investigations, actions taken and disposition of the materials.
- Support and participate in company projects.
- Implement Procedures, and work instructions to support supplier controls in QMS.
- Lead and or support, when applicable, audits and certification.
- Follow and enforce the corresponding policies and procedures, implementing solutions aligned to the needs of the business and its products.
- Support the development of Supplier Quality strategies both locally and globally.
Authority (if applicable):
This role as signatory rights as listed on Quality Management systems records and procedures.
Skills & Experience:
- At least 5 years working in the medical device industry and regulatory requirements including QSR, ISO 13485
- Strong and effective presentation skills for business cases, written documents, and interpersonal communications
- Has participated (either in back or front room) in inspection by regulating entities (e.g. FDA, Anvisa, ISO).
- Ability to work with other areas and other sites
- Ability to handle high pressure situations
- Strong English written and verbal skills, required
- Basic computer skills
Qualifications/Education:
- Degree in science, Engineering and or business administration.
- Knowledge and execution of CAPAs, Complaints and process associated with them.
- Knowledge and understanding of validations and qualifications principles.
- Has lead auditor experience according to ISO 13485
Special Factors
Travel is expected in relation to conducting supplier visits and audits.
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-ÁN1
#LI-Hybrid
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.
Already a Convatec employee?
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!
What We Do
Royal Bank of Canada is a global financial institution with a purpose-driven, principles-led approach to delivering leading performance. Our success comes from the 88,000+ employees who leverage their imaginations and insights to bring our vision, values and strategy to life so we can help our clients thrive and communities prosper. As Canada’s biggest bank, and one of the largest in the world based on market capitalization, we have a diversified business model with a focus on innovation and providing exceptional experiences to our 17 million clients in Canada, the U.S. and 27 other countries. Learn more at rbc.com.
We are proud to support a broad range of community initiatives through donations, community investments and employee volunteer activities.