Sr. Design Quality Engineer (Andover, MA)

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

We are currently recruiting for a Senior Design Quality Engineer, to collaborate with research and development (R&D) plus product support for our Sports Medicine Arthroscopic Enabling Technologies Division.

This is a fantastic opportunity to help maintain a compliant product portfolio and maintaining design compliance. Getting involved with testing strategies, verification, validation and review stages post launch of our New Product Development (NPD) portfolio.

By ensuring each process accurately meets the required criteria and quality standards allows our customers to continually receive a device and product that will help make a real difference to their lives.

Sound exciting? We believe so!

What will you be doing?

• Provide quality leadership to product support project teams as the quality engineering representative. Work with a team to develop methods and procedures to ensure that the appropriate tests are conducted to assure that products meet the required specifications/standards and that the safety and reliability of products are established. Generate/approve/manage design verifications, design validations, sterilization validations, process validations, supplier qualifications, test methods, capability studies, and risk management documentation.

• Support manufacturing operations and provide expertise in product requirements, risk management, test methods, and statistical analysis.

• Provide quality oversight and leadership for quality related issues (e.g. non-conforming material, corrections, deviations, CAPA, etc.). Investigates, documents and leads corrective/preventive actions to assure these are managed effectively.

• 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.

• Serve as a resource for training junior quality engineers.

• 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.

• Assist in other responsibilities requested by management to ensure compliance.

What will you need to be successful?

• Education: Bachelor's degree in science, engineering, or another related field

• Experience: Minimum 5 years' experience in the pharmaceutical/medical device industry or related regulated industry. Experience in equipment qualification/process validation, and measurement system analysis preferred.

• Competencies: 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

  • Must be 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

• Travel Requirements: Up to 5% domestic

You. Unlimited

We believe in creating thegreatest good for society. Our strongest investmentsare in our people and thepatients we serve.

Inclusion and Belonging-Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging. Learn more aboutEmployee Inclusion Groupson our website (https://www.smith-nephew.com/).

Life at Smith+Nephew: At Smith+Nephew, we care for one another professionally and personally. Find out more about inclusion, diversity and equity, flexibility, and wellbeing at work.

Other reasons why you will love it here!

• Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement
  Work/Life Balance: PTO, Paid Holidays, Flex Holidays, Paid Community Service Day

• Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program

• Flexibility: Hybrid Work Model (For most professional roles)

• Training: Hands-On, Team-Customized, Mentorship

• Extra Perks: Discounts on fitness clubs, travel and more

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Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.