Senior Quality Engineer (Columbia, MD)

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

The Senior Quality Engineer is responsible for providing technical and Quality support to Smith & Nephew AWB products during development, implementation, validation and commercialization. The Senior Quality Engineer applies Design Control, Risk Management, technical writing skills, statistical analysis, root cause analysis and investigation tools, knowledge of regulations, knowledge of biological and other tools to support development and manufacturing activities in a cGMP environment.

What will you be doing?

• Provides support for New Product Development and market expansion. Strong background in Medical Device Design Control and Risk Management is a must.

• Performs non-conformance and CAPA investigations to determine root cause and drive corrective actions.

• Writes, reviews and executes validation protocols, reports and other technical studies, as required.

• Performs data analysis that includes use of statistical tools, including, but not limited to trending and sample size determination.

• Performs risk assessments including Hazard Analysis and FMEA applying standards such ISO 14971

• Provides technical and quality support for various validation projects including shipping studies, stability studies, clean room validations, equipment (Lyophilizers, Autoclaves, Controlled Rate Freezers) validations, cleaning validations, microbial reduction and viral inactivation studies, process qualification and other validation types, as required

• Writes Standard Operating Procedures and Change Controls, as required

• Works independently and provide leadership to manufacturing technicians and other executors of authored protocols

What will you need to be successful?

• Education:

• Minimum of a Bachelor of Science degree in Engineering or scientific field required

• Licenses/ Certifications: CQA preferred

• Experience:

• 5 years of experience in medical device R&D, Quality Assurance, Quality Control, and/or Quality Engineering environment.

• Familiarity with human tissue regulations a plus.

• Competence in both medical product design and manufacturing quality is essential, including shop floor control and manufacturing quality engineering.

• Competence in quality management systems - design control, risk management, process validation, design quality, 21 CFR 820, ISO 13485. Working knowledge of applicable quality system regulations including US, EU, and other major global/regional standards for tissue and/or medical device products.

• Fluent in statistical software (Excel, MiniTab, R); Fluent in Microsoft programs (Word, Excel, PowerPoint, Project and Visio), Strong written and verbal communication skills

• Ability to perform software programming (R, SQL, C++) preferred

• Excellent organizational and time management skills.

• Excellent verbal and written communication skills.

• Ability to work independently.

• Technical writing.

• Proficiency in Windows and Microsoft Office Applications (i.e., Word, Excel, Outlook, MS Teams)

• Physical Requirement: Office area and manufacturing shop floor exposure, be able to lift 25 lbs infrequently

• Travel Requirements: <10-25%

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- We are committed to welcoming, Celebrating and Thriving on Diversity, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/ ).

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

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.

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