Junior Design Quality Engineer

Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.

We are currently searching for a Junior Design Quality Engineer, who will be responsible for implementing, supporting, and sustaining elements of Smith and Nephew’s quality system.  Under the guidance and direction of the Quality Engineering Manager, he/she ensures that medical device regulations, standards, and guidelines are complied with through execution of Smith and Nephew procedures. The Junior Design Quality Engineer 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.

What will you be doing?

• Provide quality support for manufacturing and product development processes and personnel to assure compliance with DOPs and GMP requirements. Pursues resolution of issues and problems as they arise.
• Support compliance and process improvement initiatives related to Operations, Engineering, and Quality functions (e.g. product quality, product transfers, complaints, labeling, validation, automation of systems, etc.).
• Lead the review, disposition, and correction/corrective action activities associated with discrepant components, materials, sub-assemblies, and finished products.
• 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. Coordinate corrective actions for issuance, review and closure of action plans.
• Support manufacturing operations and provide expertise in product requirements, risk management, test methods, and statistical analysis.
• Ensure compliance to product specific standards, cGMP, QSR, US FDA, ISO, IEC, UL, EN, MDD, and EU MDR requirements. Ensure that all the responsibilities within the scope of this job comply with the scope of the Quality System.
• Work with outside labs and suppliers to communicate Smith & Nephew product / process requirements as well as assess capabilities of the outside lab / supplier.
• Support Post Market Surveillance activities, Management Review, and audits/inspections.

What will you need to be succesful?

• Bachelor’s degree in science, engineering, or other related field
• Minimum 2 years experience, pharmaceutical/medical device industry or related regulated industry preferred. Experience in equipment qualification/process validation, and measurement system analysis preferred.
• Ability to make sound 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 is necessary
• Ability to provide and implement solutions to quality problems
• Ability to plan and schedule multiple projects and tasks
• Collaborative mindset and demonstrated ability to work effectively within cross-functional teams.
• Effective written/oral communication skills
• MS Office, MS Excel, and Statistical software proficiency
  
  

The anticipated base compensation range for this position is €26,500 - €39,750 annually.

The actual base pay offered to the successful candidate will be based on objective, job-related factors including (but not limited to) relevant skills, qualifications, and experience, scope and responsibilities of the role, geographic location, and internal equity considerations. Compensation decisions are made using consistent and gender-neutral criteria, in line with applicable pay transparency laws. This role has been evaluated within our internal job architecture and mapped to a defined pay band to ensure consistency and fairness.

You. Unlimited.We believe in creating the greatest good for society. Our Strongest investments are in our people and patients we serve.Inclusion and Belonging: Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about our Employee Inclusion Groups on our website (www.smith-nephew.com)
Your Future: Generous annual bonus
Work/Life Balance: Flexible Vacation and Time Off, Paid Holidays and Paid Volunteering Hours, so we can give back to our communities!
Your Wellbeing: Private Health
Training: Hands-On, Team-Customised, Mentorship.