Design Quality Engineer 2

Are you passionate about quality? This position is responsible for implementing, supporting, and sustaining elements of Smith+Nephew’s quality system. Under the guidance and direction of the Design Quality Engineering Manager, he/she ensures that medical device regulations, standards, and guidelines are complied with through execution of Smith and Nephew procedures. The Design Quality Engineer 2 determines methods, techniques, and evaluation criteria for medical devices. He/she serves as a key resource for ISO, EN, MDD, EU MDR, and QSR requirements.

This position is level P2

What will you be doing?

• Ensure products are being manufactured in accordance with latest regulatory requirements (e.g. GMP’s, ISO 13485, ISO 14971, MDD, EU MDR, etc.), including but not limited to generating change control records, routing bill of material (BOM) updates, and process summaries.
• Work with suppliers to ensure changes related to latest regulatory requirements (e.g. GMP’s, ISO 13485, ISO 14971, MDD, EU MDR, etc.), has been implemented, as required.
• Assist Operations during manufacturing cutover to reduce scrap costs and ensure compliance.
• Support compliance initiatives related to Operations, Engineering, and Quality functions (e.g. product quality, product transfers, complaints, labeling, validation, automation of systems, etc.).
• Assist in the preparation and coordination of Internal and External audits to International and US standards and quality policies and procedures.
• Establish and maintain successful cross-functional relations with Materials, R&D, Engineering, Manufacturing, Marketing, IT, Finance, Sales, Quality, and Regulatory Affairs departments.

What will you need to be successful?

• Education: Bachelor’s degree in engineering or related discipline.
• Experiencie: Minimum 2 years experience in the medical device or related industry.
• Languages: Advanced English level.

• Competencies: Able to make decisions with attention to details.
• Understanding the impact of regulatory requirements (e.g. GMP’s, ISO 13485, ISO 14971, MDD, EU MDR, etc.) on Smith+Nephew’s products.
• Able to provide and implement solutions to quality problems.
• Ability to plan and schedule multiple projects and tasks.
• Effective written/oral communication skills.
• Team player.
• MS Office, MS Excel, and Statistical software proficiency.

You. Unlimited

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve. 

Inclusion, Diversity and Equity- Committed to Welcoming, Celebrating and Thriving on Diversity, Learn more about Employee Inclusion Groups on our website.

Other reasons why you will love it here!

• Your future: stock purchase program, referral bonus, subsidy in transport and food, recognition program.
• Work/Life Balance: Extra days off, birthday off, voluntary hours.
• Your Wellbeing: company doctor, medical insurance, gym, health campaigns, employee assistance program, parental leave. 
• Flexibility: Hybrid work model (for more professional roles), flexible schedules.
• Training: Training program, unlimited learning.
• Extra perks: employees association, and more…